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Author Archive: 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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09/10/2013

Privacy and Whole Genome Sequencing

-->Privacy is a big topic that’s getting bigger and more complicated every day. People increasingly accept that just about anyone can find information about them on the Internet. Indeed, millions make it easier by sharing details on social media.

With respect to health and healthcare, it’s thrilling to look forward to a time when cures are found and people who have banked their genetic code can be contacted to learn about and benefit from them.  

At the same time, many are concerned about potentially negative consequences of the availability of genetic information. What if, in the wrong hands, it could affect health insurance, employment, loans, a divorce or custody case, even the chance of finding a spouse – not only for the individual but other living and future relatives?

The Center for Practical Bioethics’ 2013 Fall Symposium, “Ethical Frontiers in the Brave New World of Genomics and Learning Health Systems” on November 8 will explore the ethical implications of whole genome sequencing in light of its rapid growth and importance to Learning Health Systems, where knowledge is drawn from every encounter, both research and clinical, yet policies regarding the handling of data differ substantially. 

The Presidential Commission and Beyond

The Presidential Commission for the Study of Bioethical Issues’ report submitted to President Obama in October 2012, “Privacy and Progress in Whole Genome Sequencing,” made recommendations in six areas:

·      Strong baseline protections while promoting data access and sharing
·      Data security and access to databases
·      Informed consent process
·      Facilitating progress in whole genome sequencing
·      Public benefit from medical advances that result from whole genome sequencing

“The Presidential Commission’s work and the Center’s Symposium,” said Alan Rubel, JD, PhD, “are first steps in the process of tailoring the apparatus we already have in place to deal with the problems inherent in whole genome sequencing.” Dr. Rubel served as an advisor to the Presidential Commission, an assistant professor at the University of Wisconsin School of Law, and will join the faculty at the Symposium.

Procedures to Drive Benefit & Minimize Risk

“The potential for people to benefit and suffer negative consequences from whole genome sequencing is substantial enough that we need to develop procedures to ensure that we derive the most benefit without jeopardizing people’s well being,” said Dr. Rubel. “How information is used isn’t always clear. There ought to be some way – some standard language – to convey what the possibilities are so that people donating material or having their genome sequenced can be said to properly consent. There are issues of data security as well.”

Dr. Rubel is a strong proponent of providing more and better information to the public about what whole genome sequencing can and cannot do. “Many conditions have to do with chronic and environmental disease that can be prevented by changes in lifestyle, independent of genomics, and may be better addressed without getting into genomics.”

He also believes that concerns about privacy often mask other worries that may be best understood as issues of justice. “If, for example, our worry is that genetic information being disclosed will harm our employment, it may be that the real problem is how vulnerable people are in terms of employment, and if we deal with that, the genetic issue goes away.”

About the Symposium

At this Symposium, you will:

·      Hear updates on progress in the brave new world of genetic science.
·      Gain insight into ethical issues around data collection, privacy and informed consent, especially as they apply to genomics and Learning Health Systems.
·      Explore what type of ethical framework is needed to advance research while protecting human subjects in Learning Health Systems.

Register now at https://www.practicalbioethics.org/register-learning-health-systems. For more information, contact Cindy Leyland at 816-979-1357 or cleyland@practicalbioethics.org.

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08/28/2013

How Future Doctors Think

How Future Doctors Think
Flanigan Lecture Explores How Medical Students Make Sense of Their World

 What kind of physician do you want? Do you want someone who, out of respect for your autonomy, explains treatment options but makes no recommendations, leaving the decision up to you? Or do you want something more?

If you want something more, the research conducted by Felicia Cohn, Ph.D., who presented the 19th Annual Rosemary Flanigan Lecture on July 30, 2013, underscores the importance of knowing how your doctor thinks and helping him or her to understand your story.

Patterns in Their Stories

When Dr. Cohn taught medical ethics at the University of California-Irvine School of Medicine, she noticed patterns in the stories medical students shared concerning conflicts they encountered between their personal values and professional obligations and what they did about them. Her colleague at UCI, Humanities Director Johanna Shapiro, wondered if there might be a way to analyze and identify themes from these stories as told in 299 papers Dr. Cohn had collected.

“The themes of the students’ narratives really did fall quite neatly into six categories,” said Dr. Cohn.

• Restitution (38%)  - Appealed to a moral norm or ethical principle.
• Compromise (16%) – Conceded core values.
• Journey (16%) – Grew through experience.
• Witnessing (13%) – Felt empathy but stood by and watched.
• Resistance (9%) – Rejected professional ethics in favor of personal views
• No Problem (2%) – Never experienced any conflict.

“I thought the papers would tell a lot more stories about witnessing and compromise, which were the type of stories that the students mostly shared in class,” said Dr. Cohn. “But it turned out that restitution – appeal to principle – was the most common story they told. And more often than not the principle the students appealed to was autonomy. In other words, it’s okay for me to do this because it’s what the patient said he wants.”

Autonomy or Guidance?

Dr. Cohn explained that this emphasis on autonomy in modern medical culture has important implications for both healthcare professionals and their patients.

“If physicians really think what a patient is doing is wrong but feel that respecting autonomy takes precedence, they’re going to be spending a lot of time doing things that they think are wrong. Then they’re miserable and we go and ask them to be nice to patients. I can’t help but think that’s where a lot of the dissatisfaction and even burnout from healthcare professionals comes from.”

Conversely, for the patient who wants more than options from their physician – who wants their physician to consider how their illness and treatment will integrate into their life and make honest recommendations based on that – then the doctor who tells a restitution story probably isn’t the doctor for them.

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

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07/18/2013

A Primer on Learning Healthcare Systems

Healthcare systems and all who participate in them – providers, patients and administrators – have an obligation to pursue continuous quality improvement in order to quicken the pace of medical discovery, reduce harm to patients and improve the efficiency of care. To achieve these goals, traditional healthcare systems must transform into Learning Healthcare Systems that more seamlessly incorporate research into clinical care, continuously learn from daily patient-provider encounters, and use ever-expanding databases to inform patient assessment and treatment.

These activities raise thorny issues concerning the under and overprotection of human subjects, especially in healthcare settings where research has traditionally and formally been distinguished from treatment. Overprotective research ethics protocols can stall progress. Underprotection of human subjects exposes patients to significant risk without oversight.

The challenge faced by the LHS is to develop policies and procedures that maintain respect for human subjects and, at the same time, do not unnecessarily encumber the aggregation of data that allow investigations that lead to quality improvement.

The Center’s 30-year history in working with healthcare providers and consumers uniquely positions it to:

   · Develop consensus and common definitions as to what constitutes “low risk, low-burden” research that may not require intense oversight;

   · Raise public awareness of patient and provider responsibility to participate in research with great potential to improve quality; and

   · Implement a communications strategy to engage providers and patients in a dialogue that results in their mutual understanding of roles they play in improving health outcomes and quality.

The Center has always served as an honest broker and convener in contentious cutting-edge bioethics issues and regional health care initiatives and stands poised and ready to help communities meet the obligations of Learning Healthcare Systems.

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

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