Real World Health Care Blog

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Calling for an Integrative Approach to Pain Management

This week, Real World Health Care continues our series on pain management with an interview with Bob Twillman, PhD, FAPM, Executive Director of the Academy of Integrative Pain Management. Dr. Twillman is responsible for overseeing federal and state pain policy developments and advocating for those supporting an integrative approach to pain management. He also serves as chair of the Prescription Monitoring Program Advisory Committee for the Kansas Board of Pharmacy. Dr. Twillman previously served as a faculty member at the University of Kansas School of Medicine, where he founded and directed the inpatient pain management program and was a co-founder of the hospital’s Palliative Care Team.

Improving People’s Lives

Bob Twillman, PhD, Executive Director, Academy of Integrative Pain Management

Real World Health Care: Can you describe the mission of the Academy of Integrative Pain Management?

Bob Twillman: Our mission is to improve the lives of people with pain by advancing a person-centered, integrative model of pain care through evidence-guided education, credentialing, and advocacy. In essence, we want to promote an integrative, multimodal, multidisciplinary approach to pain management because we believe such an approach is more effective and more cost-effective in treating all types of pain, both chronic and acute. Our educational opportunities teach clinicians how to provide this kind of care, and our advocacy efforts — which are unparalleled in the pain management sphere — promote policies that encourage provisions of this type of care.

Clinician Training & Challenges

RWHC: Why is it important for clinicians to be well-versed in integrative pain management?

BT: The traditional biomedical approach to pain management doesn’t always work well for a good number of people with pain. We know — and it’s been confirmed by the Institute of Medicine and in the recently-issued National Pain Strategy — that pain is a complex biopsychosocial phenomenon, and that an integrative approach is the only safe and sane way to care for people with pain. The only way to achieve the best possible pain control for every person with pain is to use an integrative approach that addresses all aspects of this complex phenomenon, as they play out for each individual person. There is no cookbook for pain care, and one size doesn’t even fit most, so we need to use an integrative approach that permits maximum flexibility in providing care.

RWHC: What are some of the biggest challenges that clinicians face in dealing with patients’ pain management issues?

BT: Undoubtedly, access to all the treatments we need in order to provide integrative pain care is our biggest challenge. Access to integrative non-pharmacological treatments such as acupuncture, massage therapy, biofeedback and others has never been good because insurance reimbursement is poor, causing people with pain to have to pay out of pocket for these treatments — something many of them can’t do. Adjunctive treatments such as physical therapy and behavioral health care might be more readily available, but they also are subject to inadequate insurance coverage that makes true access less than optimal. And now, even the medications that have been so ubiquitous as primary treatments of pain are under fire and both insurers and policymakers are restricting access to those as well. It’s really challenging to provide the kind of care that even key governmental agencies like the CDC have been calling for.

RWHC: How is the Academy addressing these challenges?

BT: AIPM continues to advocate for appropriate access to all of the treatments we need in order to provide comprehensive integrative pain care. Often, that means we have to battle inappropriate restrictions on pain medications, but we also advocate extensively for policies that promote improved access to non-pharmacological pain treatments. Recently, we have been advocating for enhanced Medicare and Medicaid coverage of integrative pain treatments, while also advocating for more opportunities to carry out Medicaid demonstration projects that we believe will show how much can be gained if those treatments were covered. And of course, we continue to educate clinicians about ways they can provide integrative pain care even if they don’t have a large multi-disciplinary staff and insurance coverage for all the treatments they need.

Pain Management Therapies

RWHC: What are the most promising non-pharmaceutical approaches for pain management and why are they important?

BT: Consider what the pain management experts at the Department of Defense and the Department of Veterans Affairs have listed as the five evidence-based, non-pharmaceutical approaches they think every current and former service member with chronic pain should be able to access: chiropractic and osteopathic manipulations, acupuncture, massage therapy, biofeedback, and yoga. And it’s important to note here, in follow up to my previous comment on inadequate coverage, that only some types of chiropractic and osteopathic manipulation are covered by Medicare, and only for some diagnoses. None of the rest of this list of five are covered.

Additionally, we know that many people with pain benefit from physical and occupational therapy and from behavioral health interventions. If we had full access with adequate insurance coverage for these treatments, we would be delighted. Being able to get these treatments for people with pain would mean that more of them would have less pain, better functioning in a number of areas, improved quality of life, and increased likelihood of being able to work. Plus, we would spend less money achieving those improved outcomes.

Opioid Addiction

RWHC: How is the rising opioid addiction issue in America changing how clinicians address and treat their patients’ pain?

BT: For much of the past two decades, pain treatment has been primarily associated with opioid prescribing. While I think increased opioid prescribing was a well-intended attempt by the medical profession to provide better pain care, it may have been misguided due to lack of evidence, lack of access to alternatives, and the influence of a number of market forces and cultural beliefs. Now that this increased prescribing has been implicated in the parallel and sharp increase in overdose deaths involving prescription opioids, policymakers are extraordinarily active in pushing legislation and regulation intended to reduce excessive prescribing. Unfortunately, this is happening in the context of the non-pharmaceutical treatment access problems I outlined previously, without concomitant attempt to improve that access. All of that leaves primary care clinicians, who deliver the majority of pain care in this country, struggling to figure out what to do.

We are hearing from people with pain that some clinicians are responding by either setting an arbitrary dose limit for opioids, or by establishing policies that they will not prescribe opioids, regardless of the circumstances. That may be harming people who benefit from those medications, in service of benefitting those who use opioids inappropriately and in a harmful manner. I think it’s going to be a while before all of this shakes out and we can arrive at a balanced approach that maximizes the benefits and minimizes the harms for everyone.

Pharmaceutical Industry Efforts

RWHC: What should be the role of the pharmaceutical industry in addressing the rising opioid addiction issue in America? How can they work with clinicians and groups like the Academy?

BT: The pharmaceutical industry has been engaged in efforts to make their products safer, by developing abuse-deterrent opioids. These medications make it much harder to abuse prescription opioids by means of altering them to permit snorting or injecting the opioid medication. This is an important step, because it will protect people who misuse these medications — the vast majority of whom are not people with pain. If we are able to do that, then perhaps we won’t see as much of a reactionary backlash that causes people with a legitimate medical need for prescription opioids to have their prescriptions denied or taken away.

The industry can also help us by increasing funding for our education and advocacy efforts. We have so many needs for education — both for new clinicians who are now in school and for experienced clinicians who are in practice — that meeting the need is an enormous and extremely expensive task. Due to mandates for Risk Evaluation and Mitigation Strategies (REMS) education imposed by FDA, much of this funding has been redirected away from organizations like ours that can provide integrative pain management education — and without discernible benefit. We desperately need FDA to revise the REMS program blueprints so we can teach clinicians about more than just the pharmacology of opioids and so we can teach about non-pharmacological approaches to pain care. It’s really challenging for the industry to adhere to FDA mandates and to go beyond those, but we need to find a way to encourage that to happen.

Assessing Chronic Pain

Our series on Pain Management continues this week with insight on how clinicians assess chronic pain. We spoke with Bryan Jensen, PhD, a clinical health psychology postdoctoral fellow at the VA Salt Lake City Health Care System, where he treats inpatients and outpatients with chronic pain as well as facilitates primary care chronic pain recovery groups. Dr. Jensen recently graduated with his doctorate in clinical psychology from Virginia Commonwealth University, where he focused his clinical and research work serving patients with chronic disease in both inpatient and primary care populations, most notably underserved patient populations and those with high levels of co-morbidities.

Bryan Jensen, PhD, VA Salt Lake City Health Care System

We asked him about his recent Translational Behavioral Medicine article on chronic pain assessment within a translational framework and the challenges facing researchers and clinicians who are studying and treating chronic pain.

Real World Health Care: Can you provide a summary of your recent article in Translational Behavioral Medicine?

How Chronic Pain is Assessed

Bryan Jensen: As researchers and clinicians seek to treat pain, we first need to understand if we are assessing pain accurately. The article is a review of how pain is assessed across the translational continuum. It starts by exploring the basic science of animal models of pain and the types of methods used in that setting to assess pain. Clearly, these methods are not the same methods we use in clinical practice — a rat is not the same as a human — but they must translate. We are starting to understand that older models of pain assessment may no longer be adequate, so we are looking at newer models and seeking to determine a more accurate definition of pain across clinical and research settings. Other translational issues are outlined with a focus on how providers are using pain assessment tools and how they can implement newer evidence-based tools for more evidence based assessment.

The article points to three main areas that hold promise to bridge current gaps. One is using computer adapted technologies to obtain self-reported measures of pain. Because we can’t take a “thermometer reading” of pain, we rely on patients’ assessments. But pain is multi-dimensional, and asking patients to go through a 100-question survey is daunting and time-consuming, so scientists have developed computer programs that evaluate how patients respond to clinicians’ questions and adapt those responses so clinicians can more efficiently and effectively get the information they need. The NIH has been rolling out these tools over the past decade.

The second promising area is lab-based, for example, using a blood draw to look for proxy measures of pain. This is more of a downstream method to assess the patient. These tools still require further research to understand how to directly translate into clinical practice.

The third promising area is observational. In animal models, we poke a rat and watch its response. With very few exceptions — such as needle prick tests for diabetic neuropathy — we’re not going to go poking human patients. But there are observation-based methods that allow clinicians to accurately measure pain and pain behaviors. For example, the University of Alabama at Birmingham developed a pain behavior scale. Unfortunately, it isn’t widely used, even though it has demonstrated excellent validity in terms of helping providers easily and quickly measure pain and pain behaviors like grimacing, holding one’s back, and limping. It really does an excellent job giving a complete picture of a patient’s experience.

Effective Pain Treatment

RWHC: What are some of the important implications for patients and for the field of pain management?

BJ: The whole point of accurate pain assessment is to allow for more effective treatment. If patients are more aware of various pain assessment methods, they can advocate for themselves and request clinicians to widen their scope of assessment. Informed patients always help the clinical process.

The goals are improved assessment and treatment, which would lead to better patient care, higher patient satisfaction, and a reduced burden on patients, their families, and our nation. Economically, the cost of chronic pain is over $600 billion a year. If we can chip away at that, we would be making a huge impact.

Challenges and Opportunities

RWHC: What are the biggest challenges facing researchers when it comes to studying pain assessment, and how can those challenges be overcome?

BJ: From a research perspective, there’s less emphasis on assessing pain than there is on treating pain. The main challenge is a financial one, with fewer research dollars dedicated to studying pain measurement. Another challenge is a theoretical one. There’s been some exciting, cutting-edge research on neurological measures, focused on neurosignatures that act as a thermometer to measure pain, but there’s been some discord in the field as to whether this is a useful pursuit. We also need better uniformity across the literature in terms of methods and measurement. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has been working for well over a decade to develop consensus and establish best practices for measuring pain in clinical trials, but these best practices aren’t always followed.

RWHC: What are the biggest challenges facing clinicians in assessing pain, and how can those challenges be overcome?

BJ: Making clinicians aware of the latest research is a big challenge. I hear lots of clinicians express that they don’t have the training to fully assess and treat pain — especially chronic pain. Many providers approach treating someone with chronic pain with some trepidation as we have seen political, societal, and clinical swings in the use of opiates and other pain medications. Many clinicians will opt to not treat chronic pain or to seek out clinics with non-opiate policies. This is problematic, because the fact is that some patients do benefit from opiates.

We need more focus on early medical training. Medical schools are just starting to employ an integrated approach to pain, by combining the fields of primary care, psychology, pharmacy and social work. Trainees and residents are now being exposed to a broad-based perspective on how to approach and treat chronic pain, but additional course work is needed.

Clinicians also have a practical challenge. Most cases of pain are managed in primary care practices, and these clinicians are time-strapped. They default to the model of assessing pain by asking patients what their pain is on a scale of one to ten without looking at how pain impacts a patient’s functionality and quality of life. Those quality of life measures, like being able to get back to work or play with your kids, are important goals for treatment.

RWHC: What initially attracted you to this field and what continues to inspire you?

BJ: I initially became interested in the field of pain assessment when my daughter was born. She had an early medical condition — which fortunately turned out to be benign— and I was struck by the integrated team at the Shriner’s hospital who cared for her and our family. Since then, I’ve had wonderful opportunities to do clinical work with chronic pain patients. I continue to be inspired by my patients and the impact pain has on their lives. It’s gratifying to help them go from being essentially disabled to the point where they can regain their lives and take part in meaningful activities.

 

A Big Pain

Editor’s Note: This article in our pain management series originally appeared in Biotech Primer Weekly. For more of the science behind the headlines, please subscribe.

The Science Behind Opiods

Emily Burke, BiotechPrimer.com

The opioid addiction epidemic gained attention at the highest levels of U.S. policy circles this past year, as presidential candidates that disagreed on nearly everything else vowed to make fighting the problem a priority if elected. In July, the U.S. Senate overwhelmingly approved a bill to strengthen prevention, treatment, and recovery efforts. And no wonder – according to the Center for Disease Control, opioid overdose deaths are at an all-time high – a stark reality that highlights the dark side of a class of treatments serving a vital need. Opioid pain medications manage the severe short-term or chronic pain of millions of Americans. While these medications mitigate needless suffering, joining forces are the government, corporations, and medical community to battle against opioid abuse and addiction.

We wonder: what is the science behind the headlines? So, let’s talk about how pain medications work, the different types on the market, and the approaches to developing less addictive versions of opioid drugs.

Opiods vs. NSAIDS

There are two main categories of pain medications, opioids and non-steroidal anti-inflammatory drugs (NSAIDs). Although these two categories of drugs work differently, they do share one thing in common: both are derivatives of natural products. The NSAID Aspirin is a synthetic version of an extract from willow tree bark, and opioids are synthetic versions of opium and morphine, which come from poppy flowers.

Aspirin works by inhibiting an enzyme called cyclooxyrgenase 1 (COX-1). Once stopped, COX-1 is no longer able to produce signaling molecules, called prostaglandins and thromboxanes. Prostaglandins and thromboxanes have a wide variety of functions, including mediating aspects of inflammation (fever and swelling) as well as promoting neuronal response to pain. Other NSAIDs, such as ibuprofen and naproxen, also work by inhibiting COX-1 or its sister enzyme COX-2.

Opioid pain medications, such as Oxycontin and Percocet, work by binding to mu receptor proteins on the surface of cells in the central nervous system (CNS) —think brain and spinal cord. While the CNS is tasked with relaying pain signals, opioids decrease the excitability of nerve cells delivering the message, resulting in pain relief—along with a feeling of euphoria in some users. 

Lessening the Pain

Short term medical used of opioid pain killers rarely leads to addiction—when properly managed. Due to the euphoria-inducing effects of the drugs, long-term regular use, or use in the absence of pain, may lead to physical dependence and addiction. And because regular use increases drug tolerance, higher doses are required to achieve the same effect, leading abusers to consume pain pills in unsafe ways such as crushing and snorting or injecting the pills. According to the Centers for Disease Control, 44 Americans die every day due to prescription painkiller overdose. At the same time, chronic pain is also a serious problem, affecting approximately 100 million U.S. adults, while millions of others suffer acute pain due to injury or surgery. The medical need for these drugs is very real despite the dark side.

The answer to developing less addictive drugs may be found in a drug that blocks pain without inducing euphoria. These new drugs will need a different mechanism of action than traditional opioid drugs, which bind to the mu receptors of cells inside the CNS. Drugs under development include those that bind to a different type of opioid receptor, the kappa opioid receptor. These receptors are present on sensory nerves outside of the CNS.

Preclinical studies suggest that targeting these receptors could be effective at reducing pain without driving addictive behaviors. A lead candidate, CR845, is currently in Phase 3 clinical testing for post-operative pain and pruritus (severe itching), and in Phase 2 clinical testing for chronic pain. Also under development are compounds that selectively activate cannabinoid (CB) receptors outside of the CNS. CB receptors inside the CNS are linked to the psychoactive qualities of marijuana; those outside the brain are found on white blood cells and have been shown to be involved in decreasing pain and inflammation. A lead CB receptor activator, CR701, is in preclinical development.

Also under development are small molecule inhibitors of ion channels – proteins on the surface of nerve cells that help to transmit pain signals by allowing positively charged calcium ions to enter the nerve. This plays a critical role in sending the pain signal to the brain, yet because it works on nerves outside of the brain, it has less of a potential for addiction.  Phase 1 clinical studies are currently underway of HX-100 for the treatment of painful diabetic neuropathy.

Another development is a derivative of capsaicin, a naturally-occurring compound found in chili peppers. Capsaicin has pain relieving properties and has been used as a natural remedy. The lead candidate, CNTX-4975, is a highly potent, synthetic form of capsaicin designed to be administered via injection into the site of pain. CNTX-4975 targets the capsaicin receptor, an ion channel protein on the surface of nerve cells. When CNTX-4975 binds the capsaicin receptor, the influx of calcium ions results in desensitization of the nerves, making them unresponsive to other pain signals. This effect can last for months, and only affects nerves near the site of injection. CNTX-4975 is currently in Phase 2b clinical studies for knee osteoarthritis, and Phase 2 clinical studies for Morton’s neuroma, a sharp pain in the foot and toe caused from a thickening of the tissue around one of the nerves leading to the toes.

Earlier this year, researchers at Tulane University published a paper that shows great promise for the development of effective yet non-addictive pain medications. They have developed a compound that is derived from the endogenous opioid endomorphin. Endogenous opioids are chemicals produced naturally by the body that bind to and activate the mu opioid receptors, resulting in pain relief and mild euphoria without the detrimental side effects associated with opioid drugs such depressed respiration, motor impairment, and addiction. Scientist have tried before to develop safer pain medications based on endogenous opioids, but have not been successful, due to the instability of these molecules. The Tulane team created a derivative of endomorphin that is stable and binds to the mu receptor in such a way that pain relief occurs, but not the negative side effects listed above. Clinical testing is expected to begin by the end of 2017.

An Antidote to an Overdose

Overdosing can be fatal since respiratory failure occurs at high blood concentration levels of opioids. If an overdose is suspected, the individual should be treated as quickly as possible with naloxone—a “competitive antagonist” of the mu opioid receptor. Simply put, a competitive antagonist binds the receptor without activating it. Since naloxone doesn’t activate the receptor, it doesn’t have any pain-relieving or euphoria-inducing qualities; rather, it prevents the opioid drugs from binding. It may also displace opioids that have already bound the mu receptor, aiding in the stoppage of an overdose.

Cocktail Fodder: Runner’s High

Some folks love to run; others avoid it at all costs. This might be explained by inherent differences in sensitivity to the natural opioids called endorphins that are released during exercise. Not everyone experiences the “runner’s high” — feelings of calm and mild euphoria – just like not everyone experiences euphoric feelings from pain medications. These differences may help to explain why some people enjoy exercise and others don’t, and why some people get addicted to opioids—while others can take them or leave them.

 

NSCLC: The Promise of Immunotherapy

As part of our series on non-small cell lung cancer (NSCLC), Real World Health Care spoke with Hossein Borghaei, D.O., in the Department of Hematology/Oncology at Fox Chase Cancer Center, which is part of the Temple Health System. Dr. Borghaei serves as Chief, Thoracic Medical Oncology; Director, Lung Cancer Risk Assessment; and Associate Professor. He specializes in endobronchial disease, lung cancer, lung metastases, mesothelioma and thymoma and conducts research in molecular therapeutics.

Dr. Borghaei was the lead investigator of the CheckMate 057 study, which helped to introduce a new immunotherapy paradigm in lung cancer treatment.

Real World Health Care: Tell us about your role at Fox Chase Cancer Center, especially as it relates to the research and treatment of non-small cell lung cancer (NSCLC).

Dr. Hossein Borghaei, Fox Chase Cancer Center

Dr. Hossein Borghaei, Fox Chase Cancer Center

Hossein Borghaei: I’m a medical oncologist by training, with a special concentration in lung cancers. I treat patients at all stages of the disease and have run a number of clinical trials. Some of those trials have been investigator-driven, while others have been funded by the industry. I’m also involved in the Eastern Cooperative Oncology Group which does NCI-funded translational and clinical research. I also have a small research lab that does pre-clinical investigations, working with other investigators to find new ways to treat cancer patients with new or existing drugs.

RWHC: Can you share some highlights of your recent NSCLC research?

HB: The most interesting, impactful and attention-getting study I’ve been involved with recently is related to immunotherapy. This was a Phase III study in which we found that non-squamous NSCLC patients can live significantly longer with an immunotherapy drug called nivolumab than they can with single agent chemotherapy. The immunotherapy treatment has been approved, allowing physicians to use it to manage patients when there is a progression of the disease after platinum doublet chemotherapy. We also found that this immunotherapy resulted in fewer grade 3 or 4 adverse events.

We recently presented a follow-up to the study in which we found that, after a two-year time point, nearly double the previously treated non-squamous NSCLC patients and nearly triple the previously treated squamous NSCLC patients were alive compared with those treated with chemotherapy.

RWHC: What do you think are the biggest challenges in NSCLC research?

HB: We need more funding. NSCLC is a disease that affects a large population. It’s the number one cause of cancer deaths in the U.S. and it’s a very difficult disease to treat. Having adequate funding to study NSCLC is important. There are a number of drugs being investigated to treat NSCLC, so we also need patients who can participate in rationally designed clinical trials that can address specific questions and help to bring new treatments to the marketplace. There is certainly a tremendous amount of interest in evaluating new treatment options, but investigators running clinical trials are struggling in some cases to find the right patient population to study.

RWHC: What do you think are the biggest challenges relating to current NSCLC treatment?

HB: One of the biggest challenges relating to treatment comes back to the ability of patients to participate in clinical trials. Many trials are conducted in academic centers like Fox Chase Cancer Center, making it difficult for patients in remote geographic areas to participate. Even for patients who live close to a clinical trial location, they may have co-morbidities such as emphysema or COPD, making it physically challenging to participate.

Another challenge we face as clinical researchers is our ability to obtain biopsies from NSCLC patients. Biopsied tissue from tumors at different phases of the disease is critical for our ability to understand why some treatments work on some patients but not on others, and every biopsy has its risks. I’m hopeful that the emerging field of liquid biopsy — which will allow us to do molecular-level testing on blood samples — will help us overcome this challenge.

RWHC: What do you think have been the most important advances in NSCLC treatment over the past decade?

HB: Molecularly targeted therapies that allow clinicians to personalize cancer treatments have been successful for about 25 percent of lung cancer patients. Our ability to understand what’s going on in a tumor at a molecular level lets us better target specific drugs to treat and manage the disease.

RWHC: Why did you get involved in this field?

HB: As an oncology clinician, I really get to know my patients on a personal level. A cancer diagnosis is life-altering, and as a treating physician, I get to address my patients’ concerns and fears. I find that closeness extremely rewarding. From a research standpoint, there is such a huge need to understand the disease process and so many patients that we can’t yet cure. I want to contribute to our overall understanding of this disease and why it’s so difficult to treat. The research opportunities in NSCLC are almost limitless.

Non-Small Cell Lung Cancer: With Greater Understanding Comes Greater Challenges

This week, Real World Health Care speaks with lung cancer specialist, Gregory Masters, MD, FASCO, attending physician at the Helen F. Graham Cancer Center and associate professor at the Thomas Jefferson University Medical School. In addition to being Fellow of the American Society for Clinical Oncology, Dr. Masters is co-chair of the ASCO Committee for Updated Guidelines on Chemotherapy for stage IV non-small cell lung cancer. We talked about some of the challenges facing both researchers and clinicians treating patients with non-small cell lung cancer (NSCLC).

Real World Health Care: What do you see as the biggest challenges facing NSCLC researchers, and how can those challenges be overcome?

Gregory Masters, MD, FASCO

Gregory Masters, MD, FASCO

Gregory Masters: The field of lung cancer treatment is exploding in terms of our ability to understand the molecular biology of NSCLC, immunotherapies, targeted therapies and surgical techniques. We’re improving our ability to treat the disease, but we’re also challenged in terms of clinical trials. There’s a limited amount of time, limited number of patients and limited resources to design and implement those studies. More treatments mean more ways to design trials to compare and evaluate the efficacy of those treatments. So in some senses, the field is a victim of its success.

Collaboration is key, and the Cancer Moonshot program is a great example of this because it focuses on the pooling of data and resources to improve our ability to tackle the many challenges we face. We need the large cancer centers working together with community oncologists and the pharmaceutical industry to design studies, get patients enrolled and evaluate results.

RWHC: What do you see as the biggest challenges facing NSCLC clinicians, and how can those challenges be overcome?

GM: As our understanding of the biology of NSCLC increases, it adds a level of complexity for oncologists to keep up with. This is an issue that becomes more acute when you consider that the same oncologists treating NSCLC are treating other types of cancers as well, and there has been an equal explosion of research in other cancers.

We need to make sure that practicing oncologists have the resources they need for ongoing education. They need to attend relevant meetings and stay up on the latest research. They need to avail themselves of the resources available through the National Cancer Institute. They also need access to clinical trials. The real-life challenge in all of this is finding the time and energy to keep up with the latest research and opportunities. In all honesty, there are often not enough hours in the day.

RWHC: What do you think have been the most important advances in NSCLC research over the past decade? And how are those research advances changing the face of clinical treatments?

GM: The biggest advances have been in our understanding of the molecular biology and molecular genetics of NSCLC, which allow for targeted therapies. Each targeted therapy has a targeted population, which helps us make good on the promise of personalized medicine. Plus, we now have immunotherapies that allow us to “turn off” immune system regulators. In a practical sense, this means that patients who, until recently had few options if they were coming to the end of the line in terms of the ability of chemotherapies to treat their disease, now have new clinical options. Those options not only increase our ability to treat the disease, they give our patients the emotional boost they need to take the next step.

RWHC: Where do you see NSCLC research going in the next decade?

GM: It’s hard to predict. I don’t think anyone would have predicted ten years ago where we are today. But one area of promise is the further characterization of molecular changes in tumors as well as secondary changes in patients who have mutations, such as ALK mutations. This work is exciting and just in its infancy. Another area of promise is in our understanding of the immune system to determine which patients will benefit from a course of treatment and which won’t. We’re also developing a better understanding of the importance of palliative care and quality of life. All cancer patients can benefit from palliative care, but we need to expand the care team to include more people who can help, especially because oncologists are stretched so thin. We need additional resources to help our patients manage their symptoms and provide for a better quality of life.

RWHC: While exposure to cigarette smoke, asbestos and certain chemicals have been linked to NSCLC, many patients have not experienced such exposures. At the same time, other people with high exposure don’t get lung cancer. Does this mean the disease may be linked to genetics or some other factor?

GM: This is a question we’ve been asking for many years. How do we differentiate between environmental factors and intrinsic risk in a patient or a population? It’s the old nature versus nurture debate. We’re certainly improving our understanding of risk factors, but we still do not yet know why some people have a higher risk while other who smoke two packs a day don’t. We need more research in epidemiology and population-based studies. Unfortunately, those studies are hard to do.

RWHC: Why did you get into this field? What continues to inspire you?

GM: Choosing a career can be tricky. I was exposed to some great role models when I first started studying medicine and developed a deep respect for oncologists and the relationships they have with their patients. I continue to have great interest in research and learning more about cancer, but more than that, I enjoy having a positive impact on my patients—seeing them improve and seeing the gratitude of family members who appreciate what I do to help their loved ones. That’s what makes me excited to come to work every day.

How to Help Sick Kids Get Better When Insurance Isn’t Enough

During the month of August, Real World Health Care will take a short break from focusing on medical breakthroughs and the researchers who are shaping the future of medicine. We will instead bring you a special series from our sponsor, the HealthWell Foundation, about what happens when families cannot afford the medical treatments their children desperately need. The families we will profile have turned to the Foundation for help, through the HealthWell Pediatric Assistance Fund®, the only fund of its kind.

Since its launch in 2013, HealthWell’s Pediatric Assistance Fund has awarded more than $850,000 in grants to help more than 400 children start or continue critical treatments covering more than 90 disease areas and conditions, including ADHD, autism, cerebral palsy, Type 1 Diabetes, epilepsy, scoliosis, seizure disorder and many more. The Fund covers family cost-shares for surgical procedures, medical devices, counseling services and prescription drug copays. This week, we’d like you to meet Karis, whose family can’t afford her type 1 diabetes testing supplies.

Imagine this: You take your child to the doctor thinking she has an infection. You discover that she has a life-altering condition and your health insurance doesn’t cover all the costs.

That’s what happened to Alicia Bell when her daughter Karis was diagnosed with type 1 diabetes. Says Bell: “There are no vacations from being a parent, and there are no vacations from being a parent of a T1D child.”

Bell was not only surprised at her daughter’s diagnosis, she was further amazed to find her insurance wouldn’t pay for all the diabetic testing supplies Karis would need.


Did You Know?

60% of bankruptcies in the U.S. are related to medical expenses.


The Bell family is far from unique. Each year, more and more Americans are forced to choose between paying for lifesaving treatments and for food, housing and utilities. People may cut pills in half, skip meals or housing payments or declare bankruptcy. An estimated 29 million Americans are underinsured and more than 60 percent of all bankruptcies in the U.S. are related to medical expenses. In the Bells’ case, Alicia would need to go into serious credit card debt just to pay for her daughter’s diabetes monitoring and testing supplies.

“I would never want money to factor into my daughter’s health care,” Bell says. “I’d sell my

Karis and her new insulin monitor

Karis and her new insulin monitor

house and everything I own if I had to.”

Fortunately, when health insurance is not enough, there is a group that helps close the gap, putting life-changing medications within reach for thousands of people in need and helping to pay for prescription drug copayments, deductibles and health insurance premiums for critical treatments.

A HealthWell Foundation Pediatric Assistance Fund grant not only pays for Karis’ supplies—including an insulin monitor, so Karis doesn’t have to have her finger stuck several times a day—it pays the co-insurance for her hospital and clinic visits and will help pay for an insulin pump if and when she needs one.

Your generous gift to the HealthWell Foundation can help kids like Karis and others afford the medical treatments they desperately need. Consider a monthly gift, a tribute or memorial donation, or an employer-sponsored fundraiser or end-of-year giving campaign to make an extraordinary and lasting difference in the lives of kids in need. Donate today.

“Not Being Able to Afford Medication for Our Child is Devastating”

During the month of August, Real World Health Care will take a short break from focusing on medical breakthroughs and the researchers who are shaping the future of medicine. We will instead bring you a special series from our sponsor, the HealthWell Foundation, about what happens when families cannot afford the medical treatments their children desperately need. The families we will profile have turned to the Foundation for help, through the HealthWell Pediatric Assistance Fund®, the only fund of its kind.


Did You Know?

Thanks to HealthWell’s Pediatric Assistance Fund, more than 400 children suffering from 90 life-altering conditions have been able to access critical medical treatments.


Since its launch in 2013, HealthWell’s Pediatric Assistance Fund has awarded more than $850,000 in grants to help more than 400 children start or continue critical treatments covering more than 90 disease areas and conditions, including ADHD, autism, cerebral palsy, Type 1 Diabetes, epilepsy, scoliosis, seizure disorder and many more. The Fund covers family cost-shares for surgical procedures, medical devices, counseling services, prescription drug copays and other out-of-pocket costs. This week, we’d like you to meet Alejandro, who was diagnosed with Cystic Fibrosis when he was six weeks old.

In the following letter, Alejandro’s parents, Ruben and Thelma, share the challenges of affording care for their child and the big difference that HealthWell’s Pediatric Assistance Fund grant made in their lives.

Aljeandro

Aljeandro

“Our son, Alejandro, was diagnosed with Cystic Fibrosis (CF) when he was six weeks old. This was a time with many mixed emotions for our family. Alejandro is a twin and we were thrilled to welcome two new babies into our family. Along with our excitement, there were many sad times because we were scared of the unknown: CF and our biggest fear as parents came true with his diagnosis. He has a chronic illness that can be managed, somewhat, but has no cure. 

CF is a disease that requires Alejandro to take many medications and breathing treatments. As part of his treatment, his doctors prescribed medication during the respiratory syncytial virus (RSV) season. Alejandro was prescribed one shot per month for a total of five shots; one for each month from November through March. Our out-of-pocket cost is $750 [$150 per shot], which is a huge financial burden. We applied to the HealthWell Foundation for financial assistance in order to be able to pay the copayment for Alejandro’s treatment. We also contacted the manufacturer of the drug. Unfortunately, having CF does not make you eligible to receive financial support. Having a child with a chronic illness has placed a lot of stress on our family, especially on my husband and me. 

Not being able to afford medication for our child is devastating and extremely frustrating for us as parents. This is why we are so thankful for the Pediatric Assistance Fund through the HealthWell Foundation. Without a grant, we would not have been able to afford this extremely important medication for Alejandro. Receiving help was heartwarming to us because, although the contributors to the Pediatric Assistance Fund do not know our son, they were willing to donate money to ensure a child who is in need of medication receives it. On behalf of Alejandro and our family, we would like to thank all of those kind people who donate their hard earned money for children like Alejandro who need extras in order to live.”

Ruben & Thelma (Alejandro’s parents)

Companies: An average Pediatric Assistance Fund grant is $2,500. With your corporate donation, you can help children like Alejandro afford the medical treatments they desperately need. Donate today to HealthWell’s Pediatric Assistance Fund.

Focusing on Recovery, Not Financial Burdens

During the month of August, Real World Health Care will take a short break from focusing on medical breakthroughs and the researchers who are shaping the future of medicine. We will instead bring you a special series from our sponsor, the HealthWell Foundation, about what happens when families cannot afford the medical treatments their children desperately need. The families we will profile have turned to the Foundation for help, through the HealthWell Pediatric Assistance Fund®, the only fund of its kind.


Did You Know?

HealthWell’s Pediatric Assistance Fund is the first of its kind. It was opened in response to families who had nowhere else to turn.


Since its launch in 2013, HealthWell’s Pediatric Assistance Fund has awarded more than $850,000 in grants to help more than 400 children start or continue critical treatments covering more than 90 disease areas and conditions, including ADHD, autism, cerebral palsy, Type 1 Diabetes, epilepsy, scoliosis, seizure disorder and many more. The Fund covers family cost-shares for surgical procedures, medical devices, counseling services, prescription drug copays and other out-of-pocket costs. This week, we’d like you to meet Anna, who was born with a rare disorder affecting the brain.

In the following letter, Anna’s mom Mary, from Delta, Pennsylvania, shares the challenges of affording care for their little girl and the big difference that HealthWell’s Pediatric Assistance Fund grant made in their lives.

Anna, after surgery, healing & growing

Anna, after surgery, healing & growing

Our daughter, Anna was born with a birthmark on her face and scalp. The doctors suspected there was more to the story. A CT scan of her head confirmed the diagnosis of Sturge-Weber Syndrome, a rare disorder affecting the brain. We spent the next few weeks as new parents trying to understand our beautiful little girl and the rare disease she had. When she was just 3 weeks old, she had her first set of seizures. It was terrifying to see her little body so out of control. She was admitted to the hospital and started on medication. The doctors were able to control the seizures, but never for too long.

Since that first seizure many years ago, we have celebrated many days without seizures and suffered through the days when they eventually returned. We changed medications, avoided activity that might over fatigue her, struggled through specialized diets and prayed for a cure. Eventually, Anna was scheduled to undergo a radical surgery to remove the diseased half of her brain. We knew this could offer her a future without seizures, but we also knew the incredible cost we faced.

With the help of the HealthWell Foundation, Anna had her surgery. She is back home, seizure free – healing and growing. Our family has been able to focus our attention on Anna’s recovery knowing the financial burden has been reduced.

We are so grateful for the financial support the HealthWell Foundation has offered to us. With their help, we are able to celebrate the wonderful little girl God has blessed us with and we look forward to her bright future.

Help kids like Anna get the medical treatments they desperately need. Ask your employer today about how your donation to HealthWell’s Pediatric Assistance Fund can go farther with a matching gift program. Donate today.

“I Don’t Know What I Would Have Done without HealthWell”

During the month of August, Real World Health Care will take a short break from focusing on medical breakthroughs and the researchers who are shaping the future of medicine. We will instead bring you a special series from our sponsor, the HealthWell Foundation, about what happens when families cannot afford the medical treatments their children desperately need. The families we will profile have turned to the Foundation for help, through the HealthWell Pediatric Assistance Fund®, the only fund of its kind.


Did You Know?

100 percent of donations to HealthWell go directly to patient grants and services.


Sophie

Sophie

Since its launch in 2013, HealthWell’s Pediatric Assistance Fund has awarded more than $850,000 in grants to help more than 400 children start or continue critical treatments covering more than 90 disease areas and conditions, including ADHD, autism, cerebral palsy, Type 1 Diabetes, epilepsy, scoliosis, seizure disorder and many more. The Fund covers family cost-shares for surgical procedures, medical devices, counseling services, prescription drug copays and other out-of-pocket costs. This week, we’d like you to meet the Ambassador of the Pediatric Assistance Fund, Sophie.

Sophie suffers from a chronic illness affecting millions of Americans: asthma. In her own words, Sophie describes what it’s like to live with asthma and how HealthWell helped her family afford the medication she needs.

“Finding HealthWell was like a breath of fresh air,” says Pat, Sophie’s father.

Sophie is one of 14 million children in the United States whose family is underinsured. You can help kids like Sophie afford the medical treatments they desperately need by donating your tax deductible gift to HealthWell’s Pediatric Assistance Fund. Donate today. Watch Sophie’s story.

Sophie TY

 

A Tale of Two Liver Transplants: Altruistic Compassion for a Compassionate Altruist

Editor’s Note: Real World Healthcare will be taking a brief hiatus during the month of August. During this time, we’d like to share with you some of the compelling stories we’ve published about patients facing both medical and financial hardships.

 

“Talk about your life changing in an instant,” Helen said, remembering her first diagnosis of acute liver failure. The doctor told her family there was nothing more to be done, and she was given two weeks to live.

Helen Bozzo

Helen Bozzo

Helen Bozzo had spent most of her time being a mother. Her husband, a farmer, worked long hours in the fields in their rural California farm, and early on in their marriage the couple decided that she would stay home to care for their three children. She was the “homeroom mother,” volunteering in classes and with the school’s administration, PTA and athletics department. Helen’s passion was helping others, and not just in the school.

Eventually moving into the town, Helen enjoyed taking others into her home – her children’s friends, her son’s comrades from the Marine Corps – she always had a full house and enjoyed taking these friends in like her family.

“I enjoyed cooking for everyone, reading, knitting and gardening,” she said. “Still things I enjoy doing today, but loving and helping people is my number one pleasure in life.”

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A Note from Our Sponsor: Are you, or is someone you love, an MS patient on Medicare in Need of Financial Assistance? Click here to visit the HealthWell Foundation’s eligibility page.

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Helen had returned from what she remembers as a great family vacation to Disneyland when she began to get ill quickly. Her doctor had her admitted to her local hospital where, after receiving tests and specialists’ opinions, she was given that shocking diagnosis.

But her family could not accept that. They sought a second opinion, and got Helen an appointment at a local cancer center. Here she was evaluated and admitted to the hospital, where she spent a month undergoing “every test known to man” and waiting desperately for an answer. All that was clear was that her liver and now her kidneys were failing. She was placed on dialysis.

“I was going downhill fast,” Helen recalls.

After much deliberation, Helen’s doctors decided to put her on the transplant list. Eight days later, on April 29, 2007, a suitable liver was available and she had the transplant. Her health began to improve immediately.

More than a third of people on the transplant list die each year waiting for an organ, according to Helen. She would later come to realize just how lucky she was, saying, “The odds of finding a match in such an acute critical case as mine are astronomical,” she said. “The doctors told me later that I was within hours of death.”

For the time being, Helen was in the clear. She had great insurance and her payment plan kept her bills covered. Though she was in debt, she was able to keep her medications coming. Considering how hard her recovery was, that was a very good thing. It took Helen a year to be able to walk again, but she eventually made a full recovery.

For the next four years, things went well for Helen. She became active again, and that meant re-embracing her spirit of altruism. She became active in the organ donor/recipient community, particularly in a liver transplant support group in which she helps others through the process of getting a transplant. She became a California Donate Life Ambassador, speaking at various organizations about the importance of becoming an organ donor. What energy Helen had, she gave to others.

Shortly before her third walk with the American Liver Foundation’s “Walk for Life,” Helen decided she had to see her doctor. She had started feeling tired after a recent road trip with a friend, and now she was feeling worse. To her dismay, the doctor’s test showed some major problems. After ten days of testing in the hospital, her liver was failing again. She was placed on the “Status 1” list in five states, the top of the transplant list.

“It was life or certain death,” Helen said.

Three days later, on September 26, 2011, Helen had her second liver transplant.

Along with this transplant, however, came three expensive new medications that her insurance would not cover. Charging thousands of dollars to her credit card every month, Helen was becoming massively over-extended. She called every agency she could, but no one could help her until she found the HealthWell Foundation. HealthWell is a nationwide non-profit providing financial assistance to insured patients who are still struggling to afford the medications they need (and sponsor of this blog). Helen qualified for a grant that helped cover her copays for her medications.

Now, Helen and her husband are back on their feet. As always, Helen turned her attention to paying it forward to others as soon as she could, donating to the HealthWell Foundation, continuing to support transplant recipients and raising over $25,000 in her walks for research and awareness of liver disease and failure. She spends time with her ever-growing family and her husband, with whom she just celebrated 40 years of marriage. When she’s not helping others or enjoying the love of her family, she still likes to knit, garden and cook, and hopes to see all 50 states one day.

“We are so very thankful to the HealthWell Foundation,” Helen said. “I know of families in our transplant support group that have lost their homes because they were in the same situation we were in. Thankfully we found the HealthWell Foundation in time. The home we had worked so hard for, we were able to keep. The peace of mind in knowing that every month when I went to the pharmacy I would have the money to pay for my medications meant everything to our family. The stress was gone and I could focus on my recovery in peace.”

We at RealWorldHealthCare are thrilled to see patients like Helen in such good places, doing such wonderful things. Please share your thoughts in the comment section.