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Author Archive: Practical Bioethics

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05/13/2015

ETHICS OF THE POLITICS OF PAIN

Picking Up the Gauntlet

On May 1, the Center for Practical Bioethics hosted an ethics symposium, something they do every spring. What made this event special enough that it moved me to write about it was the topic, Healing What Hurts: The Politics of Pain.

I’m a bit of an oddball in the pain world. I am not a healthcare professional, nor am I person with chronic pain. I am not an academician or researcher; I don’t work in industry. I am someone who came in the ‘side door’ to the pain world providing services like strategic planning, meeting coordination, and program/project management to organizations like the Center. I can’t truthfully say that helping to change the way pain is perceived, judged and treated is a personal passion of mine. But it has become something I believe in and care about, a testament to the incredible people at the Center with whom I have the privilege of working, and my exposure to the thinking and work of individuals like those who presented last week.

At the symposium, I felt like I was witnessing the creation of a beautiful tapestry, with each speaker picking up the thread of those who came before and continuing to weave the threads together until the complicated (and troubling) reality of the polarizing space in which pain currently resides was achingly clear. Some threads:
  • Historian and author Dr. Keith Wailoo’s spellbinding historical dissection of the poles our policymakers and courts have swung between in answering the questions, “Whose pain matters and who deserves care?” While historians feel more comfortable looking back instead of ahead, Dr. Wailoo did offer some insight into my question of how to have success this time around in making sure that reimbursement model changes follow our ability to demonstrate that comprehensive multi-modal pain care holds down costs and improves outcomes.
  • Dr. Kathy M. Foley (I view her as the Grand Dame of this continent’s pain movement) exposing the harsh realities of care being forced to focus on what’s reimbursable vs. what’s best for the person with pain.
  • Dr. Bob Twillman laying bare the damage caused when overly simplistic policy and action around harm reduction focuses solely on cutting down on the supply of prescription narcotics, without looking at the demand side and asking, “In which patients should we use opioids, at what doses, for how long, with which adjunctive treatments, and with what precautions?”
  • Dr. Richard Payne sharing some pretty mind-blowing emerging science about how the social determinants of health most closely associated with underserved populations actually affects one’s biology. Melissa Robinson from the Black Health Care Coalition made it real for the impoverished in Kansas City.
  • And, pain pioneer Dr. Lynn Webster, pain advocate Janice Lynn Shuster, and public policy expert Katie Horton reminding us all that the lives of people in pain matter and their stories must be heard.
Having worked in this arena for over a decade, I will own that the fight to make things better for people with pain feels akin to running a marathon in five feet of mud – it’s a slow slog even on good days. The assembled audience sensed there may still be some dark days ahead before the pendulum swings back towards reason and progress. But the conviction that things will get better and that we must continue the fight was evident in abundance.

Who else but the Center could and would provide the kind of thought provoking and engaging delve into the ethics of the politics of pain? There may be others, but the Center picked up the gauntlet and ran with it. And for that, they have my love, admiration and respect. [In the spirit of full disclosure, I currently do some consulting work for the Center on the PAINS Project.]

Written By Ann J. Corley, MS

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05/01/2015

Granny Takes an Art Class

My Journey with Elizabeth Layton

Although it was nearly 40 years ago, I remember seeing Elizabeth Layton's drawings for the first time as if it were yesterday. I was a young reporter for The Herald newspaper in Ottawa, Kansas, when I saw two of these drawings. They made me laugh and cry at the same time. Drawings of an old woman with big green eyes that reached out to me.

Then, I learned from her art teacher at Ottawa University that Elizabeth Layton was 68 years old and taking her first art course. This, I realized, would be a good story for my newspaper, "Granny Takes Art Class." Meeting her, however, I realized that this was more than a one-time story for the Ottawa Herald. It would be my life.

When the story appeared in The Herald, I had also arranged for a dozen of her drawings to be shown at the local library. Visiting her weekly, I learned more of the story. She had been depressed half her life and undergone shock treatments. Learning to draw helped to cure her depression. It was gone six months after she began drawing by looking at herself in a mirror and drawing not only what she saw but what she felt.

I was able to arrange for one-person exhibitions of her work in about 160 museums across the country, including the Smithsonian. And I was able to get coverage of her in Life, People and Parade magazines, as well as NPR and Good Morning America.

She and I had an understanding and a mission. We knew that viewing her drawings could and has helped people – people dealing with their own aging, their own depression, their own families. And the drawings could help people better understand the social issues around them – racial injustice, homosexuality, the environment, homeless, and on and on.

Elizabeth had to draw and I had to get those drawings "out there." It was my therapy during the last 16 years of her life and the 22 years since.

By Don Lambert, Curator

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04/21/2015

ODE TO A BLONDE BOMBSHELL

When I first met Bonnie Peterson 30 years ago, I thought, “Wow! You’re the nurse guys dream about!” She was young, blonde and beautiful. What I couldn’t tell at first blush was that she was also one of the smartest and most tenacious nurse leaders I have ever had the privilege of working with, and without question, the strongest advocate for nursing, nursing ethics and bioethics that I have ever known.    

Bonnie and I both had new jobs. She was the new Vice President of Nursing/Clinical Care at Children’s Mercy Hospital (CMH) here in Kansas City, and I was the Executive Director of a brand new freestanding bioethics center, Midwest Bioethics Center (now the Center for Practical Bioethics). The year 1985 was a great one for Bonnie. That year she married her Pete Peterson, an attorney who knew how lucky he was to have landed Bonnie. They adored one another.

Ethics Committee Pioneer


CMH was one of the Center’s “early adopters.” There was a group of physicians there who had met regularly for a number of years and included one of our founders, Hans Uffelmann, a philosopher at the University of Missouri – Kansas City. It was sort of a “journal club.” They would all read articles, and then meet for breakfast to discuss them. Hans convinced the group that they should transition into a hospital ethics committee, which was quite the thing for hospitals to do at that time, and that he and others at the Bioethics Center should consult with them in this transition and provide ethics education to them. 

They agreed, and Bonnie was the administrator with whom we worked and who oversaw this transition. Ultimately, however, CMH established an ethics committee under the authority of the medical staff. Unfortunately, to them this meant that, although nurses were welcome to participate in the educational activities, they could not serve as committee members. (There was a lot of brouhaha about legal protection from disclosure regarding  intimate case conversations.) Having come to know Bonnie and being aware of how much effort she had put into this, I thought she would be furious, but not so. That was not her style.

She let the guys proceed (and they were all male physicians), and she established a “nursing ethics forum” where nurses met monthly to also discuss difficult cases. It could not be called an ethics committee because there already was one in place and it was for physicians only. In a short time, however, physician members of the ethics committee became open to nurses presenting cases before their group and, eventually, nurses and others were invited to serve on the ethics committee. That’s the way Bonnie did things. Unlike me, she never stomped her feet or demanded anything. She simply decided what she thought best, and then she made it happen – quietly, unrelentingly….

Leader, Teacher and Mentor Extraordinaire


And what she thought was best was very impressive. She was part of the team at CMH that planned a new wing of the hospital with a Kaleidoscope theme. She was involved in CMH opening auxiliary clinics and ultimately a second hospital in the Kansas City metropolitan area, bringing hospitals together to support air ambulance services that none of them could afford separately, and establishing a neonatal ICU at another hospital. She was also an active and dedicated member of the Bioethics Center. It was rare for us to hold any event that Bonnie was not present. She even participated in a week-long nursing ethics intensive seminar hosted by the Center, although she could have taught the course herself and actually served on the faculty for nursing leaders that followed her group. 

After more than a decade, Bonnie left CMH. She accepted executive positions in a couple of other KC hospitals, but Bonnie loved children. That’s where her heart and passion were and that’s where she went – to the Children’s Hospital of Wisconsin. And when she called, we went to “do ethics” with them, and whenever she was in Kansas City, she called and came by the Center. 

Fortunately, for us Bonnie ultimately returned to Kansas City, in part, to pursue her life-long dream of completing her PhD in teaching at the University of Kansas. None of her friends could understand why she thought she “needed” a PhD. Bonnie Peterson was one of the best teachers I have ever encountered, and her students LOVED her. She served on the Advisory Board for the School of Nursing as did I. 

Colleague and Friend


One of my greatest honors was to have been recognized as an honorary alumnus by the School of Nursing. It wouldn’t have been like her to share that she was the one who nominated me. I learned that later from someone else.

Bonnie also came home because she was having some health problems. I can’t remember when Bonnie was diagnosed with cancer; it seems like a very long time ago. However, I do remember when I was diagnosed with cancer. It was in January 2011. Bonnie was right there for me. I got phone calls, notes, books, love and encouragement from her. In thinking about how to express my respect and admiration for Bonnie Peterson, I decided to share that Bonnie Peterson was the one person in my circle of family, friends and colleagues with whom I cried and told her how frightened I was. In her inimitable way, she said, “We’ll be okay. Nobody is better prepared than are you and I to deal with these issues. We’re good at making tough decisions about healthcare, and I’ll be there when you need me.” 

Like many others, I feel blessed to have known Bonnie Peterson, PhD, RN, and I will miss her. 


By Myra Christopher, Kathleen M. Foley Chair for Pain and Palliative Care
Center for Practical Bioethics

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04/14/2015

LIVING WILLS, GREYHOUNDS AND GOALPOSTS

National Healthcare Decisions Day – April 16, 2015

By John G. Carney, MEd, President and CEO
Center for Practical Bioethics


For years, I’ve been curious to know whether people fail to complete living wills and avoid naming a healthcare agent out of procrastination or a false sense of confidence that they have plenty of time to do it later.

Reality is, if you don’t do it when you don’t have to, it’s not likely to go well when you do. Naming someone during a time of crisis to speak on your behalf can be downright cruel, especially when you’ve not shared much about the things that are really important to you.

Share What’s Important

What are those things? Well, they aren’t scary or monumental. They include things like how important laughing, talking, sharing and “just being” are to you. Don’t get all tied up in feeding tubes. Instead think about what sharing a meal means to you. Is it a means to an end or an end in itself?

I once shared a house with an older-than-me bachelor and swore when he ate at home he never cooked anything that didn’t come in a box and could go in a microwave. I, on the other hand, started just about every meal sautéing fresh onions and garlic in olive oil. Food had entirely different meanings to us, and that became starkly evident to me when we talked about his dad’s early onset Alzheimer’s and how differently he approached the question of feeding tubes when the difficult question arose in his family.

So stop worrying about a tube in every orifice! Instead think about the sharing what you want more than anything – even at the end. Don’t obsess about completing a living will (aka healthcare directive) to the point that it paralyzes you from acting. Instead, take the time to share with someone who loves and cares for you what’s important to you as you think about life in general and especially its final stages. Focus on the positive - the most fulfilling aspects of your life. This isn’t a “bucket list” of items to do, but rather a sharing of values and convictions. What do relationships, solitude, faith, nature, self-expression and art, work, music and family mean to you?

Then, when that’s all done, ask that person to be your agent. And then promise that person that you’ll do it again in a year or two down the road – or whenever you have a major event in your life – from the birth of a child to the diagnosis of a serious illness. Life happens and, while our wishes and dreams may alter, you’ll be comforted by the fact that values – real bedrock beliefs about life and love – pretty much stay the same. But don’t assume even those close to you know all that.

Recognize Greyhounds and Goalposts

Over the years I’ve learned about two very important syndromes that all of us deal with differently. One is called the “Greyhound Syndrome.” It’s the phenomenon that sometimes we experience a great freedom of anonymity sitting next to a perfect stranger (on a bus traveling cross country) and share our deepest thoughts more freely than we do with those we’ve shared a lifetime with. Hospice volunteers can regale you with stories they’ve heard, never to share again, by a dying patient. These are not necessarily dark secrets of our past so much as unvoiced hidden treasures. Some are worth sharing before we die; others are worth taking to the grave. Think about which is which.

The other syndrome is what’s called “Moving Goal Posts.” This phenomenon deals with how some future state or health condition may appear unacceptable at one point in our lives and much more acceptable at another. That’s why checking boxes and lists on living will forms doesn’t work for people in states of relative good health. But stories, treasured thoughts, values and convictions work at every level.

Have a Caring Conversation Today

So take a leap and share your stories with someone you love. And, this April 16, on National Healthcare Decisions Day, have a caring conversation. Name an agent. Start talking about what matters most and don’t make it a somber depressing discussion. Think about it as a gift to those you love that will lead to peace of mind – for you and them. Because it likely will – far more likely than leaving it to chance. Close to 85% of us will have to rely on someone else to make our final wishes known. 

If you need help getting started, we’ve got a little booklet that will help you do just that. Download a free Caring Conversations workbook or order a printed version from the Center for Practical Bioethics’ website.

Seize the moment and turn what you thought was morbid and ghoulish into the marvelous and glorious. You may just discover something about a loved one that will serve you both in the moment and for a lifetime.

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04/13/2015

Gratitude for Rev. Gardner C. Taylor

Remembered by Dr. Robert Lee Hill, Senior Minister
Community Christian Church, Kansas City, Missouri

When a comprehensive American religious history of the 20th century is finally compiled, the magisterial preaching eloquence of the Rev. Dr. Gardner C. Taylor will be remembered with astonishment and abiding, awe-struck admiration. Dr. Taylor died on Sunday, April 5. He was 96.

For more than 70 years, Dr. Taylor held forth among African American Baptists and a panoramic array of religious adherents throughout the United States and around the world as an orator with few if any peers.

MLK’s Favorite Preacher

As the pastor of the Concord Baptist Church of Christ in Brooklyn, New York, for 42 years, and afterwards in retirement, Dr. Taylor engaged the issues of his community, the nation and the world with passion, insight and effectiveness. He artfully combined the necessary durative dynamic of transcendence with the equally necessary punctiliar character of incarnation.

With Martin Luther King, Jr., who called Dr. Taylor his “favorite” preacher, he helped found The Progressive National Baptist Church in order for congregations to better address and overcome the ravages of racism and segregation in the U.S. Working from the North, he led the Concord church and many other congregations to raise funds for Dr. King’s efforts in the South.

Dr. Taylor also served on the New York City Board of Education and was always involved in issues that arose in the “public square” of Brooklyn and greater New York. In his later years, Dr. Taylor worried that many religious leaders and their congregations had lost their “prophetic edge” and might fall into the trap of merely mirroring a consumeristic culture.’’

Compassion Sabbath in Kansas City

Whenever he spoke and wherever he travelled, Dr. Taylor dealt with ethical issues and matters of public significance, including when he came to Kansas City.

The Center for Practical Bioethics will remain abidingly thankful for Dr. Taylor’s presence in Kansas City in 1999 at the launching of “Compassion Sabbath,” which engaged more than 80,000 faith community leaders and members in hundreds of congregations in an interfaith initiative to increase the quality of care for those facing the end of life. At a breakfast gathering at Union Station, he spoke compellingly of the need for honesty and compassion in relation to the experience of debilitation and pain at the end of life.

During the time of a sabbatical journey in 2010, I was privileged to share a long interview/conversation with Dr. Taylor in his home in Raleigh, North Carolina. In retirement, Dr. Taylor echoed in his meditations what he put forth as a preacher, pastor, and activist for the betterment of humanity. Well into his 90's, Dr. Taylor spoke plainly and with swift clarity about the process of aging. When asked about what he prayed for, he said his personal prayers were "to get out without too much pain." And he added, with a chuckle, "And I'm ready to get out, I'm ready to go."

People in the pew, the academy of homileticians, and awe-struck fellow clergy regarded Dr. Taylor as a singular personality whose like only comes around once every century or so. We would agree and only add that we’re so glad that he came to Kansas City to share his extraordinary voice for the intertwining for what is “good” and what is “right.”

Note: The Kansas City Star published an article about Dr. Gardner on April 11, 2015, describing his pulpit as “the most prestigious in black Christendom.”

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04/09/2015

Do Your Little Bit of Good: National Pain Strategy Comment Period Ends May 20

Do Your Little Bit of Good:
National Pain Strategy Comment Period Ends May 20


2.2 Create a comprehensive population health-level strategy for pain….
(Complete before the end of 2012)


In June 2011, those of us who served on the Institute of Medicine’s committee that published Relieving Pain in America sent our report to Congress. It included sixteen recommendations to improve care for at least 100 million Americans who live with chronic pain. It provided what we referred to as a blueprint to “transform the way pain is perceived, judged and treated.”

Our first recommendation (2.1) was to “improve the collection and reporting of data on pain.” We had all been dismayed to learn how little reliable data we actually had to draw from in our process. The second recommendation (2.2) was to “create a comprehensive population health-level strategy for pain prevention, treatment, management, and research. Our “blueprint” was fundamentally a timeline which sequenced our recommendations. We ranked the population health-strategy as our first priority and asked that it be completed within 18 months, i.e., by the end of 2012.

It has been my privilege to serve on the National Pain Strategy Oversight Committee, which was charged by the Department of Health and Human Services (HHS) with developing the plan called for by the IOM. Unfortunately, that charge was not issued until the end of 2012 and the process took much longer than we had anticipated. The committee’s work was completed last summer and then it entered the vetting process. The good news, however, is that last week the National Pain Strategy Report was posted in the Federal Register. Until May 20, 2015, recommendations and comments from the public are possible.

We wish to strongly encourage all of those interested in efforts to improve chronic pain care to review this document and share your thoughts about it. You can do so by going to -
https://www.federalregister.gov/articles/2015/04/02/2015-07626/draft-national-pain-strategy

The report is only 43 pages and is organized in six sections: 1) Population Research, 
2) Prevention and Care, 3) Disparities, 4) Service Delivery and Reimbursement, 5) Professional Education and Training, 6) Public Education and Communication.

Each section contains a statement of “the problem” and then provides objectives and strategies for remedying that problem. From my perspective, some of the Report’s most important objectives are to:
• Foster the collection of more and better data for all populations, including developing metrics for measuring progress. (Good solutions always start with good facts.)
• Determine and analyze the benefit and cost of current prevention and treatment approaches and create incentives for using those treatments with high benefit-to-cost ratios. (Get the biggest bang for the buck.)
• Develop standardized and comprehensive pain assessments and outcome measures intended to increase functionality. (Move beyond 1-10 pain scales.)
• Acknowledge and address biases in pain care. (Biases that are implicit, conscious or unconscious.)
• Demonstrate the benefit of inter-disciplinary, multi-modal care, including behavioral health, for chronic pain. (Pain is a complex issue that requires complex solutions.)
• Align reimbursement with care models that produce optimal patient outcomes. (Both public and private payers are critical to reform.)

Perhaps, most important of all, however, is to improve health literacy, communication and education about pain among patients, healthcare providers, policy makers and the public. 

More than 80 pain and policy experts from across the country volunteered their time to develop this report. Many others in federal agencies have also been involved, and all agreed to the following vision:
If the objectives of the National Pain Strategy are achieved,
the nation would see a decrease in the prevalence across the
continuum of pain, from acute, to chronic, to high-impact
chronic pain, and across the life span from pediatric through
geriatric populations, to end of life, which would reduce the
burden of pain for individuals, families and society as a whole.
Americans experiencing pain – across the broad continuum —
would have timely access to  a care system that meets their
bio-psychosocial needs and takes into account  individual
preferences, risks, and social contexts.  In other words they
would receive patient-centered care.


Further Americans in general would recognize chronic pain  
as a complex disease and a threat to public health and a just
and productive society. 


All those involved in developing the report are committed to getting it right, and to do so, it is critical that people living with chronic pain, their families and those who care for them (especially primary care providers) provide input and feedback. To paraphrase Bishop Desmond Tutu, “Do your little bit of good…. It is those things put together that change the world.”


https://www.federalregister.gov/articles/2015/04/02/2015-07626/draft-national-pain-strategy


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04/01/2015

It is Time to Ditch Pain Scales

Western medicine is in large part based on objective evidence. If you can’t see, touch, taste or weigh it, it simply does not exist. Unfortunately, pain is subjective, with no “litmus test.” Each individual’s pain experience may vary depending on one’s genes, culture and/or world view, including religious beliefs.
Pain scales were an attempt by well-meaning people to address this problem. The idea was that if a mechanism were devised to make pain more comprehensible, less subjective, not quite so “slippery,” people with pain would get better care. And, at the same time, those who care for them could be more confident that they were doing the right thing when prescribing medications that have serious side effects, including addiction and unintended death. Pain scales also helped assure providers that they were treating people fairly — without regard to age, race, ethnicity, etc. - so that a person with a pain score of seven would be treated like any other person with a pain score of a seven.
Unfortunately, this grand experiment has not worked.

Although today pain is assessed far more often than it was before pain was labeled the 5th Vital Sign and pain scales were devised, there is significant evidence that pain care is no better than before.
On March 30, an article by Amy Dockser Marcus appeared in the Wall Street Journal titled, “In search of a better definition of pain.” In it, Tamara Michael, a 45-year old women who lives with chronic pain due to Multiple Sclerosis, describes work she has done with a group of researchers to come up with a better way to assess patients’ needs for pain control. They have come up with a narrative assessment based on functionality, i.e., a person’s ability to do activities of daily living (ADLS) – things most of us take for granted like the ability to dress ourselves, prepare a meal, or drive a car.
I applaud Ms. Michael and the researchers working with her and others in the article who commented on the need for a better mechanism to accomplish the goals that motivated those who developed the Pain Scale. However, I think there is a bigger issue here than what assessment tool we use and that is the stigmatization of those who live with chronic pain, which has led to the erosion of trust between healthcare providers and those who live with chronic pain.
Pain patients are often characterized as “drug seekers,” malingerers, lazy and told that their real problem is “all in their head.” They are also seen as putting those who care for them and prescribe pain medications at risk of scrutiny by state medical boards, as well as local, state and federal law enforcement agencies. Although pain is the number one reason people seek medical care and the desire to address pain and suffering is what “calls” most people to the healthcare professions, we are at a “medical impasse.” Doctors feel threatened by their patients, and those living with pain feel abandoned by their physicians.  
So, how do we find our way out of this quagmire? The Institute of Medicine report, Relieving Pain in America, published in 2011, called for a “cultural transformation in the way pain is perceived, judged and treated.” It also called for a shift from a biomedical to a bio-psychosocial pain management models, i.e., an approach that provides access to multi-modal treatment that could include medications and interventional procedures, but also access to counseling and behavioral health, physical therapy and exercise, diet and nutrition counseling, chiropractic care, acupuncture, massage and other complementary and alternative treatments. Bio-psychosocial approaches are both comprehensive and individualized. 
In 2015, a National Pain Strategy Report, which is an effort to operationalize recommendations made in the IOM report, will be published. I am hopeful that it will serve as the springboard for the “cultural transformation” called for in the IOM report. However, I believe that, until the loss of trust between pain patients and healthcare professionals is restored, it will have little impact, and from my point of view, the only thing that will restore that is communication – respectful communication.
I was in the hospital recently and noticed that at the foot of my bed was a whiteboard that told me the name of the hospitalist, the nurse and the nurse aide on duty. It also included a 1-10 pain scale printed right on the board, including little happy-to-sad faces for patients who do not read. When one of my daughters saw it, she said, “Wow! Mom, the pain scale is printed right on the board. That ought to make you feel great.” Unfortunately, it did not. It made me think about how difficult it will be to undo the 1-10 Numeric Pain Scale and to put in its place a more patient-centered approach, like the one reported in the Wall Street Journal, or an even simpler, more humanistic approach such as physicians asking, “How are you today?” Then listening to and respecting the patient’s response. 

Written by Myra Christopher
Kathleen M. Foley Chair in Pain and Palliative Care

Learn more at http://www.practicalbioethics.org

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03/04/2015

Group-Level Expanded Access to Unapproved Medicine: The realistic solution for patients


Guest Blog Author: Jess Rabourn*, Managing Director, ALS – Emergency Treatment Fund


Since 1962, Federal law prohibits open sales of any new pharmaceutical product until that product goes through years of clinical research and is granted approval by the FDA.  

Yet unapproved new drugs are provided to thousands of patients daily.  They’re not openly sold, but instead made available by drug companies to study safety and effectiveness in humans.    FDA allows such managed uses of unapproved drugs through authorized Investigational New Drug (IND) exemptions, which are filed by drug companies, physicians, or other program sponsors.

INDs are filed for clinical trials that are intended to gather data and to support marketing approval.  Additionally, INDs for Expanded Access may be filed when seriously ill patients lack access to traditional clinical trials and there is no other effective treatment available.  Expanded Access programs were used extensively in the late 1980s and early 1990s to provide exploratory treatment to persons living with AIDS. As new antiretroviral drugs were studied in research trials they were simultaneously made available in much larger Expanded Access programs for the many patients who were too sick to take part in the research trials.

Between 2002 and 2012, a new class of lifesaving TK-1 inhibitors was made available to tens of thousands of cancer patients through several Expanded Access programs.

FDA understands the need for treatment options and has a track record of liberally authorizing Expanded Access through group-level “Intermediate Size INDs” and larger group “Treatment INDs”.  A third kind of Expanded Access IND exists for exceptional single-patient cases, but this channel is inappropriate for most diseases, provides no useful data, and is almost never agreed to by the drug companies.  True Expanded Access programs enroll on a group level just like regular clinical trials and require no patient-level FDA filings.

Despite the easy regulatory pathway, drug companies struggle to justify the costs and burdens of providing their product to patients before commercialization.    THIS factor, more than any other, is what keeps dying patients from accessing safe exploratory medicines.  As a consequence, there aren’t nearly as many access programs as there are eligible drugs in deadly diseases.

To address this gap, a nonprofit company called ALS Emergency Treatment Fund (ALS-ETF) was formed in 2012.  ALS-ETF was built to sponsor Expanded Access programs as an independent third party, for ALL patients who otherwise have no access to investigational medicine.  Through FDA-authorized cost recovery, ALS-ETF can engage healthcare payers, patients, and charitable assistance funds to ensure enrollment is both scalable and fair.  Participating clinics work in partnership with the platform –not as service providers- allowing ALS-ETF to manage large, centrally-coordinated Expanded Access programs at little or no cost to drug companies.  Well-designed Expanded Access programs can generate vast amounts of patient response data, which is especially valuable in poorly understood diseases.

This responsible solution works under the laws that already exist and has been enthusiastically received by FDA, drug companies, and research organizations in multiple disease areas.



* Mr. Rabourn spent the first 15 years of his career in institutional asset management and was awarded the Chartered Financial Analyst designation in 2004. He held a senior position at a New York hedge fund until 2008, when his dad, Frank Rabourn, showed the first symptoms of ALS. From that point onward, he has made it his full time career and personal mission to change the treatment landscape for current and future rare disease sufferers.  Mr. Rabourn is involved in multiple drug development ventures and, in 2012, joined three ALS families to launch ALS Emergency Treatment Fund, a professional service provider and a leading authority on Expanded Access programs.

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02/26/2015

The Center for Practical Bioethics Weighs In on Proposed “Right to Try” Legislation in Kansas

A perspective from John G. Carney’s (President, Center for Practical Bioethics) based on testimony before the House Committee on Health and Human Services (HB 2004, Right to Try)


Most of us would agree that the “Right to Try” legislation proposed in the State of Kansas is appealing in the world of ideas and the realm of rhetoric where personal freedom and the pursuit of limitless aspirations are admirable ideals. But the world of reality bends its merits to questionable decisions that may disrupt the safe delivery of care to the most vulnerable population that healthcare professionals are called to serve.

In bioethics we recognize the deep-seated human impulse to rescue the imperiled, which is what this legislation seeks to do. However, we also grudgingly acknowledge that we could not run our businesses, public and private services or health care systems while indulging this impulse without limits. Furthermore, it is also widely accepted that “spectacle ethics” that turn individual cases into cause célèbre should not dictate public policy – no matter how heart-breaking they are. In the real world, there are good reasons to think that the “Right to Try” legislation should not be pursued despite our natural impulse to rescue.

While the popular framing of this issue characterizes interventions as miraculous and life-saving, there is little to no evidence that the interventions actually result in a good or “hoped for” outcome. We are not bound to provide a treatment that offers no benefit. In fact, it is a violation of our moral duty to do so.

Proponents may argue, if there is some evidence in the first phase of the clinical trial process that the patient may benefit from this treatment, then we should allow them access in the face of their impending death. Urgency is a given in these instances and experts argue that impending death is a criterion that allows for special consideration in these cases. But we are also obliged to consider the facts before arguing for new legislation to provide that consideration. 

Recent efforts within the FDA clearly demonstrate the agency’s attention to this issue. The FDA has updated and expanded its expedited processes for accommodating requests for access to drugs under development called Investigational New Drug (IND) Application. FDA Commissioner Dr. Margaret Hamburg has reported that in FY 2013, the most recent year for which data are available, nearly 100% of all applications submitted were approved (974/977) and many of those requests processed within hours of submission.

FDA has further pledged to continue to streamline its efforts despite its mandate to ensure safety and efficacy. For individual states to adopt legislation that circumvents the process of safety and efficacy places undue burdens on private business and manufacturers. Drug and medical device companies have repeatedly expressed concerns about their ability to handle and process the applications diverted from the FDA.

Furthermore, drug manufacturers are under no obligation to provide access to their products. The effects of unlimited access to drugs that have only been through Phase One clinical trials cannot be known and subverts the scientific process. In turn, accommodating appeals by individual patients ultimately diverts private business interests on the basis of questionable practices.

The substantive ethical and practical problems associated with this bill, coupled with the fact that these instances are exceedingly rare (estimated to be about 5 cases a year in Kansas), raise serious doubts about its merits. Significant and promising collaborative efforts are underway, such as the ALS Emergency Treatment Fund, that offer far more hope to patients than “Right to Try.”

The agencies that provide for our safety and ensure the efficacy of treatments operate in the real world, as does the legislature. Despite our natural need to rescue the imperiled, this committee and this body retain the responsibility to legislate with prudence and wisdom.

John G. Carney, President and CEO
Center for Practical Bioethics

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02/07/2015

Chronic Pain — The Invisible Public Health Crises

Chronic Pain -- The Invisible Public Health Crises

A Call for Moral Leadership

“I am an invisible man. No I am not a spook like those who haunted Edgar Allen Poe: Nor am I one of your Hollywood movie ectoplasms. I am a man of substance, of flesh and bone, fiber and liquids- and I might even be said to possess a mind. I am invisible, simply because people refuse to see me.”
- Ralph Ellison

Ralph Ellison’s famous novel, The Invisible Man, starts with this passage, which also reminds me of the problem of chronic pain. The Institute of Medicine (IOM) report, Relieving Pain in America, documented the more than 100 million Americans (almost 1 in 3 and surely someone whom you know and love) suffers from chronic pain, at an economic cost of $6 billion and an incalculable psychological cost. We named pain as a “disease” because of its profound effects on the brain and its interference with multiple domains of the quality of life of sufferers. The committee identified chronic pain as a public health problem, given the sheer numbers affected, and the opportunities to intervene to prevent acute pain from becoming chronic pain. However, the report is now almost four years old, and it is fair to say has not really moved the needle in doing what we implored in the IOM report—“changing the way in which pain is judged, managed and perceived.” Why is that?

Because pain is subjective -- and therefore difficult to measure by the usual medical tests -- it is often doubted. As someone once said, my pain is real, your pain is in doubt. Also, we live in profound cultural ambivalence about pain. Cultural icons such as  Julius Caesar and Albert Schweitzer have been quoted as saying that pain is worse than death, but there is also an ethos of “no pain, no gain.” Medical interventions, particularly powerful opioid drugs such as morphine and oxycodone, although essential to manage acute and persistent pain, come with a cost of many side effects and may induce psychological dependence in some. Persons in pain and their doctors fear addiction, although we do not truly know the risk of addiction in persons taking opioids who have not abused recreational or illicit drugs. For these and other reasons, on an individual and societal level, we prefer to ignore the problem of chronic pain, unless confronted by it in our personal lives.

So how do we advance the moral imperative to address pain and suffering in contemporary medical practice, as required by our ethical codes and professional oaths? How do we bring the invisible suffering of so many to light and work to alleviate it? I think we commit ourselves to five big goals:

1. We advocate for more and better science to understand the underlying neuroscience of pain production and modulation. This requires advocacy at the NIH and other federal agencies to fund worthy science related to pain mechanisms and clinical trials of pain treatments.

2. We advocate for more and better drug development, including the creation of abuse deterrent opioid formulations and novel non-opioid based analgesics. This will require advocacy for effective public-private partnerships between the pharmaceutical industry, academia and federal agencies.

3. We advocate and demand better education of health care professionals to live up to their obligations to be competent and to attend to pain and suffering in their patients. We also advocate for better public education so that persons suffering with chronic pain understand that this is a disease, and not subject to quick fixes.

4. We advocate and demand better policy solutions to provide sustainable and patient-centric interdisciplinary pain treatment programs that truly address patient and provider needs. 

5. Finally, we need effective collaboration on a shared policy agenda between pain specialists and substance abuse specialists to advocate for comprehensive, rehabilitation-focused care for chronic pain, and greater access to substance abuse treatment for those persons who have a dual diagnosis of chronic pain and addiction.    

These are my thoughts. What do you think?

Richard Payne, MD
John B. Francis Chair, Bioethics
Center for Practical Bioethics

Esther Colliflower Professor of Medicine and Divinty
Duke University

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