PATIENT-CENTERED RESEARCH CAN IMPROVE CHRONIC PAIN CARE AND ADDRESS OPIOID ABUSE

Going for the Brass Ring

Last year, Joe Selby, MD, executive director of the Patient-Centered Outcomes Research Institute (PCORI), spoke to members of the NIH Interagency Pain Research Coordinating Committee (PCORI) to inform those of us on the committee about PCORI’s intentions to do more funding focused on chronic pain research. Dr. Selby said their interests were possibly in low back pain, migraine, musculoskeletal pain, and/or opioid abuse. I was elated. Then about a month ago (May 14, 2015), Dr. Selby posted a blog on the PCORI website titled, “Patient-Centered Research Can Improve Chronic Pain Care and Address Opioid Abuse.” 

I hope with all my heart that he is right; research or policy that can do both of these things is like grabbing the brass ring while on a merry-go-round. It is certainly a worthy goal but, to many, seems all but impossible. If anybody can do this, however, PCORI may have the best chance. Established by the Patient Protection/Affordable Care Act in 2010, PCORI’s mission is to “examine the relative health outcomes, clinical effectiveness, and appropriateness of different medical treatments” – particularly complex problems that threaten the health and well-being of all Americans. Chronic pain certainly meets that criterion.

In Dr. Selby’s blog, he said, “Since 2012, PCORI has built a sizeable portfolio of studies on chronic pain, two of which specifically address opioid treatment.” He went on to list some of the questions these studies have focused on:

• How can we improve patients’ ability to communicate confidently with doctors about pain and pain medication?
• What approaches to care delivery can minimize health and safety risks when long-term opioid use is considered?
• What collaborative-care approaches to pain can improve quality of life, patient satisfaction, and adherence to other treatments?
• How can we encourage patients to join and stay enrolled in integrative treatment plans that show promise of reducing chronic pain while lowering risk for opioid abuse?

He also informed readers that, in June, PCORI would be hosting “multi-stakeholder workshops” to discuss whether comparative effectiveness research (CER) can be helpful in addressing these issues. 

The week before Dr. Selby posted his blog, I was pleased to receive a letter from him inviting the Pain Action Alliance to Implement a National Strategy (PAINS) to send four representatives to two workshops in Washington, DC – one focused on low back pain and the other on long-term use of opioids in the treatment of pain. We quickly accepted, and on the morning of June 8, two members of the PAINS team and two of our Citizen/Leaders (people living with chronic pain and/or family members caring for chronic pain sufferers) went to the airport excited about traveling to our nation’s Capitol and participating in these important discussions. After six hours at the airport and our second plane cancellation due to mechanical problems in Kansas City and bad weather in DC, I emailed our PCORI contact to tell him that we would not be coming to DC, and we headed home with heavy hearts. 

The next day, I tried to participate in the opioid workshop remotely, but technical difficulties that even their “help desk” didn’t seem to be able to overcome, made it all but impossible for me to do so. I must say, however, that I am grateful to one of the meeting participants and the facilitator of the “opioid workshop” for their extraordinary efforts to include me. I am also grateful that the next day the PCORI facilitator sent me the rank-ordered questions that emerged from the workshop and gave me permission to share them. They are very interesting, and can be seen at:  

http://www.pcori.org/events/2015/prioritizing-comparative-effectiveness-research-questions-long-term-use-opioids-chronic

That afternoon I wrote to Dr. Selby to express our gratitude for PCORI’s interest in chronic pain and to explain to him why PAINS representatives were not at the workshops the day before. I said that it is our view that, “PCORI is essential to the ‘cultural transformation in the way pain is perceived, judged and treated’ called for in the IOM report, Relieving Pain in America, and echoed in the forthcoming National Pain Strategy Report.” I also invited him and/or others at PCORI who he would deem appropriate to visit Kansas City to meet with our team and PAINS’ Citizen/Leaders. I told him that our Citizen/Leader Group has met with and advised us for more than two years and that they have been enormously helpful. I encouraged him to activate the following link (and click the link there to the video, “The Faces of Pain”), so that he could meet some of these outstanding individuals:

http://practicalbioethics.org/resources/chronic-pain-resources

I also suggested that these remarkable people and others like them could be very helpful to PCORI, in fact, I believe, essential, as they build out their pain portfolio. I also offered to arrange for us to come to DC if it was not possible for them to come to Kansas City.

The ambitious goal PCORI has set -- comparative effectiveness research that will improve chronic pain care and address opioid abuse -- will require the involvement of many stakeholders. The most important among those may well be people who struggle to live with chronic pain and family members who care for them day-after-day. PCORI’s very name implies that they understand that. I look forward to hearing from Dr. Selby and welcoming him and others to Kansas City. In the meantime, I can almost hear the calliope music on the merry-go-round.

By Myra J. Christopher

Myra J. Christopher is the Kathleen M. Foley Chair in Pain and Palliative Care at the Center for Practical Bioethics and Director of PAINS.

The Ethics of Resuscitation

A Brief History and Center for Practical Bioethics’ Efforts to Improve CPR Outcomes

Promise and Problems

Cardio-pulmonary resuscitation has offered food-for-thought for philosophers and bioethicists from its beginning, and the Center for Practical Bioethics has a long history of grappling with this subject.

In 1966, the National Academy of Sciences reported that closed chest cardio-massage and CPR should be ordinary treatments for hospitalized patients. Before that, CPR was a “hit-and-miss” proposition. Through the 1970s and 80s, the use of CPR became more prominent in hospitals, and CPR expanded to include defibrillation. In 1984, the year the Center was incorporated, Johns Hopkins Hospital became the first to incorporate automated external defibrillators (AEDs) into resuscitation efforts.

CPR was original intended for those who experienced cardiovascular arrests that were witnessed (i.e., those who died of a heart attack observed by someone with CPR skills). By the late 1980s and early 90s, it was being applied to all those who died in hospitals – and raising questions. One writer referred to it as “medical creep.” Another said, “Resurrecting the dead became medicine’s obsession.” Another referred to death itself as a “recurrent problem.”

DNR Orders

The Center for Practical Bioethics and others imagined that issuing do not resuscitate (DNR) orders would protect patients, who had little to no chance of benefiting from CPR, from the harms that can result when CPR is used inappropriately. Typical among these harms are broken ribs, burned skin, massive bruising, and being caught between life and death with little “quality of life.” Ron Stevens, MD, then head of Oncology at the University of Kansas, said that CPR was the “least aesthetically pleasing intervention done in medicine.” Another physician, one of the Center for Practical Bioethics’ “near founders,” Bill Bartholome, MD, wrote an article for the Annals of Internal Medicine in 1988 in which he said, “What is needed is a new perspective, a new way of thinking about Do Not Resuscitate Orders (DNR). We need to come to understand that in most tertiary medical centers and nursing homes the only predictably good candidates for the use of CPR’s techniques are staff and visitors.” 

For the most part, DNR orders were recognized in hospitals, but as, Medicare and state regulatory surveyors saw resuscitation as a quality measure, physicians were often hesitant to write such orders in particular for frail, elderly patients without capacity and/or when families were demanding that “everything possible be done.” And when patients who did have a DNR order left the hospital, there was no way for the DNR order to follow them home.

New Guidelines and Strategies

The Center for Practical Bioethics and others recognized that the near universal practice of attempting to resuscitate everyone who died in a hospital was ethically flawed and that questioning CPR in peer-reviewed journal articles and its efficacy at professional conferences was not enough to safeguard patients.  

In 1988, the Kansas City Regional Hospital Ethics Committee Consortium convened by the Center followed the lead of a community-based project in Hennepin County Minnesota that created a way for DNR orders to expand beyond the hospital settings. With our emergency medical service providers, local hospitals and nursing homes, Kansas City became the second community in the country where patients at home could have a DNR order that would be honored. The Kansas City initiative was featured in the Annals of Emergency Medicine.

The Consortium also created policy guidelines for DNR Orders in Nursing Homes and for Honoring DNR Orders During Invasive Procedures. The Spring 1998 issue of Bioethics Forum contains these Consortium guidelines. Because of this work, the Joint Commission (then JCAHO) sought the Center’s help in developing their standards.

POLST and Beyond

That same year the Center became aware of POLST (Physicians Orders for Life Sustaining Treatment) in Oregon, which expanded from unwanted and potentially harm treatments statewide. In 1999, the Center published a policy brief reporting Oregon’s initiative in Issue 3 of its publication, State Initiatives in End-of-Life Care. Implementing a POLST-like project in Kansas City has been challenging because our community straddles the state line. Today, the Center in concert with large healthcare-providing institutions leads a similar project called Transportable Physicians Orders for Patient Preferences (TPOPP). It is the first bi-state “POLST paradigm” initiative in the country. TPOPP educational materials and resources can be found at practicalbioethics.org.

The Center’s work in this area has long included inviting scholars from across the country to speak about their research and writing on this topic. On August 12, 2015, 7:00 pm, we will continue providing education and opportunity to learn from national scholars and one another when David Casarett, MD, presents the 21st Annual Rosemary Flanigan Lecture at St. Joseph Health Center in Kansas City, Missouri. Dr. Casarett is a tenured professor at the University of Pennsylvania Parelman School of Medicine and the author of Shocked: Adventures in Reviving the Recently Dead, a complete history of CPR.


By Myra Christopher and Rosemary Flanigan, PhD

21st Annual Rosemary Flanigan Lecture

SHOCKED: Adventures in Bringing Back the Recently Dead

August 12, 2015
Reception 6:00 pm
Lecture 7:00 pm
St. Joseph Medical Center
Alex George Auditorium, Building D
1000 Carondelet Drive, Kansas City, MO

David Casarett, MD, associate professor of medicine at the University of Pennsylvania, will explore the history, science and moral hazards of reviving the “recently dead.”

A Right to Be Shocked?

Back in the 18th century, concerned citizens were experimenting with ways to bring back the dead. But they didn’t make a lot of progress. Indeed, the 19th century was not a particularly productive one for the science of resuscitation, and the first part of the 20th century wasn’t much better.

Fortunately, though, there were other important advances during that period, including many new discoveries and inventions. There was the airplane, of course (1903), and the ballpoint pen (1935), and let’s not forget the machine that makes sliced bread (1927), as well as the first Rock & Roll song (1951). That, by the way, is widely believed to be “Rocket 88”, by Jackie Brenston and his Delta Cats, which beats the heck out of Schubert or Chopin, if you ask me.

But if you were a cardiac arrest victim who was “apparently dead” in 1951, your chances of survival probably weren’t much better than they would have been 100 years before. On the bright side, if you were lucky enough rejoin the living in 1951, you’d be able to wake up to the world’s first Rock and Roll song.

Things Have Changed

In the last 50 years, things have changed. A lot. Now resuscitation is no longer the province of medical professionals. Anyone can resuscitate anyone. Moreover, it’s a revolution that we’re all part of, whether we know it or not. If you have two arms, and a sense of rhythm, you can perform CPR.

That’s not such a bad thing. Certainly the science of resuscitation has improved, and CPR does save lives. So encouraging bystanders to try their hand at bringing back the dead seems reasonable.

On the other hand, a try at resuscitation seems to have become mandatory. It’s the new default. Unless you happen to have an “out of hospital” Do Not Resuscitate (DNR) order, or a highly visible bracelet (or a tattoo), if your heart stops there’s a good chance that someone is going to feel compelled “to do…. something!”

That’s a little worrisome. I’m thinking of the court case that resulted from the death of Mary Ann Verdugo, who died in a Target store in 2008. Her family brought a lawsuit against Target because, they said, the store did not have an Automatic External Defibrillator (AED) available to its customers. That case is making its way slowly through the courts. In the most recent development, the California Supreme Court found in favor of the store, saying that it didn’t have a duty to provide defibrillators. The case isn’t over, though. Now it goes to the 9th Federal Circuit Court.

Crowdsourcing Resurrection

Regardless of how that suit is decided, it’s going to have interesting implications for the ongoing revolution in crowdsourcing resurrection. It also will raise many questions that we’ll need to think through very carefully.

Do we all have an obligation to try to bring someone back from the dead?  Should we assume that person lying on the floor wants us to try? How much evidence to the contrary do we need in order to decide that resurrection shouldn’t be an option?

These are difficult - and perhaps impossible - questions for the paramedics, doctors and nurses in medical settings who wrestle with them every day. And that’s concerning, because now we’re asking everyone to make those decisions. Bystanders, resident service directors and even gardeners will need to start thinking about whether and when resurrection is appropriate, necessary and the right thing to do.

These difficult questions are multiplying, as the revolution in crowdsourcing resurrection is speeding up. It took 200 years to get the hang of CPR. Now we have defibrillators that are proliferating in malls and airplanes and bus stations. And there are more developments on the horizon.

Sure, we’ll get better at bringing back the dead. That’s good news for people who can rejoin the living, and especially for those who want to. But as the tools of crowdsourcing are increasingly available, we need to figure out whether and how to use them.


By David Casarett, MD

Dr. Casarett, a researcher and tenured professor at the University of Pennsylvania Perelman School of Medicine, will present the 21st Annual Rosemary Flanigan Lecture on August 12, 2015.

How was Henrietta Harmed?

The HeLa Legacy

I recently had the pleasure of meeting two of Henrietta Lacks’ descendants when I participated in a panel discussion with her granddaughter Kimberly Lacks and her great-granddaughter Veronica Spencer at Metropolitan Community College, Longview’s Spring Convocation on April 16th, 2015. The story of Henrietta Lacks was chronicled in the best-selling book The Immortal Life of Henrietta Lacks by Rebecca Skloot. This African-American woman, who died in 1951, is the source of the famous HeLa cells. These cells, obtained from a biopsy of Henrietta’s cancerous cervix, are unique; they are immortal in the sense that they have been growing in tissue culture since they were removed from her body in 1951 by doctors at Johns Hopkins Hospital.

Henrietta and her HeLa cells have a complex legacy. Although the cells were taken without Henrietta’s truly informed consent, they have been used in medical research to make important scientific advances ranging from the development of the polio vaccine to new drugs to treat HIV and cancer. Despite this incredible contribution to medicine, her role as the source of these cells has been obscured until recently. (In medical school, I first learned of these remarkable cells as ‘Helen Lane’ cells.) Neither she nor her family or descendants received any monetary compensation, although pharmaceutical companies have profited enormously from drugs developed using her cells. And, in a striking irony, many of her descendants lacked health insurance to provide access to the very medical treatments that HeLa cells had enabled.

Despite these facts, I was once asked by a bioethicist the following question: How exactly was Henrietta Lacks harmed? After all, would it not be the case, even today, that patients undergoing surgery for cancer would give tacit or formal written consent for their doctors, or researchers associated with their doctors, to use tissue obtained from surgery for medical research, and expect no formal recognition or financial compensation?

Direct and Indirect Harm

I believe Henrietta was harmed. She was directly harmed because she was not fully informed of the risks and benefits of undergoing particular medical treatments for her cancer and participating in research. Admittedly, the standards of informed consent and, in particular, consent for research participation have changed dramatically since 1951. However, there has always been a universal medical ethic to be truthful, and to hold the patient's best interest as the primary responsibility of the physician. These are two critical elements of the concepts that have now come to be named as autonomy and respect for personhood. The obligation to be truthful and to inform patients about the risks and benefits of their medical treatments were firmly enshrined in medical ethics even back in the 1950’s. The failure to live up to these responsibilities was partly responsible for the physical pain and suffering that Henrietta Lacks endured.

Henrietta was also indirectly harmed through the impact her treatment has had on her family and descendants. Like many others who live marginalized lives in marginalized communities—as surely was the case in the 1950’s in segregated city of Baltimore and arguably remains the case even today—they do not have faith in the integrity of the medical institutions that are supposed to serve them.  From personal communication with the family, I know that absence of trustworthiness manifested by Johns Hopkins in their treatment of Henrietta continues to influence the current attitudes of her descendants toward medical care in their community. This is an ongoing harm. 

Making Amends

What might Johns Hopkins and the medical establishment do to make amends to the descendants of Henrietta Lacks? One important step has been taken recently. The National Institutes of Health (NIH) announced an agreement with the Lacks family to protect their personal privacy and give them a say in how some research using HeLa cells is conducted. Specifically, the genome data of the Lacks family, which was revealed when the HeLa cell genome was decoded, will be accessible only to those who apply for and obtain permission from a committee of the NIH that includes members of the Lacks family.

Furthermore, the investigators must acknowledge the contribution of the Lacks family in their publications and presentations of their research data. However, the NIH agreement does not include a financial compensation for the family. 

Johns Hopkins, an elite and powerful institution, could also make an overt commitment of resources to create and advance programs that promote better access to care for poor and marginalized groups in Baltimore. The institution should work to identify and repair factors at work in the community that adversely affect health. Furthermore, it should explicitly identify these programs as a form of compensation, or reparations, for past ethical breeches that contributed to these problems. This should be undertaken in the name of Henrietta Lacks in recognition of both her extraordinary contribution to science and medicine and her family’s remarkable commitment to the continued use of her cells for the betterment of humanity.

The Henrietta Lacks story teaches us many things. One important lesson is that it is never too late to acknowledge and to make amends in the present for the great wrongs that have been committed in the past.




Written by Richard Payne, M.D.