Archive for June, 2010
Inside the Process of Authoring a Book: Diane Meier on Palliative Care: Transforming the Care of Serious Illness
Our recent book, Palliative Care: Transforming the Care of Serious Illness (Jossey-Bass, San Francisco 2010), has been a long time coming. I got the invitation from my co-editors Stephen Isaacs and Bob Hughes of the Robert Wood Johnson Foundation over three years ago. The book was to be another in an annual series of books on health reform in areas of significant investment by the Foundation. Prior volumes addressed the Campaign for Tobacco Free Kids and School-Based Clinics, among others. I was asked to both write an introductory essay placing the field in context, and to help select a series of previously published articles for reprinting in the volume. The audience for the book was a matter of some discussion- we settled on the educated public and, we hoped, health care policy makers. The reprints were to serve as the signal and seminal pieces that exemplified the evolution of the field from its inception to its current status.
Sounded simple enough.
Many, many, hours and three years later, we had a draft ready to go press. The articles were chosen with a great deal of input from colleagues in the U.S. and around the world and lots of great pieces of writing had to be left out for lack of space. My essay started with the roadside hospices for the Crusaders of medieval times and ended before the passage of the 2010 Accountable Care Act and I learned way more than I anticipated about the threads that contributed to our field now- the 14th century origins in church-sponsored hospitals for the poor and hopelessly ill; the evolution of the place of death from a familiar experience to a mistake in the “medical model” of the modern world; the new science of pain and pain management in the 1970’s; the revolutionary and determined roles of three middle aged women (British nurse, social worker and physician Cicely Saunders, Dean of Yale University School of Nursing, and University of Chicago physician Elisabeth Kubler Ross) in a male dominated medical business culture; and the power of a federal payment mechanism (the Medicare Hospice Benefit) as a mediator of social change. The development of the field of palliative care as an approach to the human experience of illness and disability stands on the shoulders of at least a thousand years of social evolution. Humbling. It helps to understand what came before in order to think about what should happen next. Some people want to use the book in colleges and universities and Schools of Public Health. Hope for the future.
The Hospice and Palliative Care initiative in VA took on renewed strength and vigor in 2008 when specific funding was allocated to this initiative. Since then, Palliative Care Consulting Teams (PCCTs) have been developed in every VA facility. Regional oversight of these teams is being provided by a Program Manager and a Clinical Champion, positions that VA Central Office directed regional offices to hire. Partnering with all major national hospice and palliative care organizations, the VA has now entered the crucial phase of training and educating its staff. Train-the trainer programs specific to VA have been developed by these national organizations to meet the needs of all disciplines providing palliative care services to veterans.
Opportunities are usually accompanied by challenges, which are not significantly different for VA than for the non-VA palliative care programs. Supply of a skilled workforce, access to quality palliative care, and evidence based practice standards are some of the prevailing challenges.
The VA has positioned itself as a leader in hospice and palliative care. It is reassuring to know that this most important and essential part of health care has also become integrated into the mainstream of the care we provide to our nation’s heroes.
The AAHPM Delegation to the American Medical Association (AMA) House of Delegates welcomed back a good friend and effective representative at the AMA’s 2010 Annual Meeting in Chicago, held June 12-15. Dennis S. Pacl, MD FACP – who was instrumental in the securing the Academy’s seat in the House and once served as its delegate – rejoined the team as Alternate Delegate, replacing Ron Crossno, MD CMD FAAFP FAAHPM, who is now focused on serving the Academy as its President Elect. I was pleased to accept the appointment to fulfill Dr. Crossno’s term on the AMA Pain and Palliative Medicine Specialty Section Council (PPMSSC) and will serve as Acting Vice-Chair through November 2010. Aided by key AAHPM staff – including CEO Steve Smith, Jackie Kocinski and Laura Davis – the Academy’s small, but effective delegation enjoyed another active and successful meeting.
Protecting and Expanding Past Achievements
The AMA periodically reviews established policies to ensure their relevance over time. After acceptance of its report on the ethics of palliative sedation to unconsciousness (AAHPM Bulletin, Summer 2008), the AMA’s Council on Ethical and Judicial Affairs (CEJA) planned to “sunset” an older policy that addressed decisions at the end of life. This older policy included concise definitions of key terms used in palliative care and clear statements about the ethics of withholding and withdrawing care outside of the realm of palliative sedation to unconsciousness. The AAHPM Delegation testified about the older policy’s enduring relevance, and the House of Delegates retained it as AMA policy in deference to the Academy’s continuing interest.
The AAHPM Delegation and PPMSSC also offered support to a passed resolution that asked the AMA to recognize, yet again, the benefit of hospice at the end of life and to encourage attending physician collaboration with hospice staff who are caring for their patients. This resolution will result in an AMA study of the Medicare Hospice Benefit and issues related to access issues for eligible patients. Your delegation expects the Academy will be involved in the development of this AMA report.
VA Physicians’ Access to Prescription Drug Monitoring Programs (PDMPs)
In April 2010, a member of the AAHPM Public Policy Committee brought forward for discussion a directive from the U.S. Department of Veterans Affairs (VA) Office of General Counsel (OGC) that restricted VA physicians from participating in state Prescription Drug Monitoring Programs (PDMPs). The OGC directive is based on concerns about patient privacy and informed consent issues inherent to PDMPs. At the AMA meeting, the Kentucky delegation introduced a resolution that opposed the OGC directive, which afforded a welcome opportunity for the AAHPM Delegation to advocate aggressively for Academy members who practice in VA hospitals.
In reference committee hearings, AAHPM testified in favor of Kentucky’s resolution based on three principles. First, the Academy argued that VA physicians should have access to the same prescription data as non-VA physicians as a matter of fairness and equity. Secondly, as evidenced by recent U.S. Food and Drug Administration (FDA) efforts to create a Risk Evaluation and Mitigation Strategy (REMS) for long-acting opioids, all physicians share a role in creating a balance between protecting patients’ legitimate access to controlled medications and assuring the public’s safety; PDMPs represent useful tools for achieving that balance. Finally, the AAHPM noted that while the OCG’s concerns about privacy and consent issues are prudent, they do not automatically trump issues of public safety, civil justice and professional autonomy from an ethical or legal standpoint.
Other Achievements in the AMA House
AAHPM co-sponsored a resolution with the American Geriatrics Society (AGS) and other specialty allies, urging the AMA to recognize an ongoing need for physicians who care for older adults to be competent in geriatric care and encouraging adequate geriatrics training in medical school and graduate education. This resolution passed with broad support, and it parallels Academy efforts to incorporate palliative care education into medical school and graduate curricula.
Lastly, through its involvement in the PPMSSC, AAHPM supported the acceptance of a report by the AMA Council on Science and Public Health (CSAPH) that addressed recent scientific findings on the pathogenesis of neuropathic pain. This included a recommendation for increasing the use of the term “maldynia” and integrating the objective concept of neural injury into the subjective experience of chronic neuropathic pain, a practice that would potentially benefit patients who suffer from disability related to neuropathic pain.
(Any AAHPM members interested in learning more about the work of AMA or joining the AMA should contact Chad Kollas, AMA Delegate, at email@example.com or Dennis Pacl, AMA Alternate Delegate at firstname.lastname@example.org.)
Saudi ARAMCO Medical Services Organization
May 24-26, 2010
I participated in a fascinating international medical conference at the Saudi ARAMCO hospital in Dhahran, Saudi Arabia. I was invited to speak on palliative care topics during a geriatric and palliative care conference by Dr. Richard Dupee, chief, Geriatrics Service, Tufts Medical Center. Dr. Charles Cefalu, a geriatrician at Louisiana State University joined us as a speaker.
During the conference we spoke about a number of typical geriatric topics including the management of behavioral problems in dementia, the evaluation and prevention of falls and urinary incontinence. In an overview of the concept of palliative care, I discussed the evaluation and treatment of delirium, talked about artificial nutrition and hydration and discussed techniques for difficult conversations among other topics. I found discussing many of these topics challenging given the vast cultural differences seen in the Arab world.
While I wasn’t lecturing I met with a number of physicians, nurses and hospital leaders and discussed hospice and palliative medicine concepts. The hospital is interested in establishing a palliative care service as well as a home health care service, but they face significant cultural barriers. For example the concept of “Do Not Resuscitate” is only very recent development in the hospital and the concept is still not widely endorsed by many physicians, patients or families. I got the impression most patients and families expect to have resuscitation attempts no matter the underlying disease process or prognosis.
When I discussed the lack of evidence of benefit for gastrostomy tubes in patients with advanced dementia, many in the audience voiced anecdotally based skepticism. It appeared to me that patients, families and physicians simply expect patients with advanced dementia will receive tube feedings. Additionally the physicians mentioned they are prohibited from prescribing strong opioids for non-malignant pain and methadone is not available in the country of Saudi Arabia.
Despite these challenges the staff is ready to proceed with developing a palliative care program and home health care. It will be interesting to see how the significant cultural challenges will impact the progress of their work, and I look forward to working with them in the future.
I often encounter misconceptions about elder mistreatment. The following are the most frequent misconceptions and my responses to them. Please let me know by your replies if you agree with the following.
1. Elder Mistreatment cannot or should not occur with good hospice or palliative care.
Elder mistreatment occurs even under the best of hospice or palliative care. Hospice and palliative care patients and families have many risk factors for elder mistreatment including caregiver stress, functional and cognitive decline, increased isolation, and increased dependency. The interaction of their decline and pre-existing psychosocial dynamics make these patients high risk for mistreatment. While an interdisciplinary team may reduce or mitigate the risk, the team cannot eliminate the risks in these complex cases.
2. The responsibility to investigate elder mistreatment belongs to the social worker.
The social worker is not equipped on her own to determine elder mistreatment. She does not have sufficient medical background or training. Because elder mistreatment is as much a medical problem as it is a social one, clinicians need to be involved. The team physician should exert leadership in assessing the medical aspects of mistreatment, such as decision making capacity, suspicious physical findings, and medication over-dosing or under-dosing. Addressing elder mistreatment is the responsibility of the entire team.
Investigation of elder mistreatment is a responsibility that belongs to Adult Protective Services, the Ombudsmen, or law enforcement. Hospice and palliative care social workers do not have the forensic resources to perform an adequate investigation.
3. Elder Mistreatment must be confirmed before it is reported.
The threshold for reporting is reasonable suspicion not confirmation. The team does not need to confirm the mistreatment before making a report. As long as the team believes a reasonable likelihood mistreatment occurred, a report should be made. Again the responsibility to confirm mistreatment rests on the receiving agency, not the reporting party. The hospice or palliative care team does not have the forensic skills necessary to confirm mistreatment.
4. The patient or family will be upset if an Adult Protective Services (APS) report is filed.
If the hospice or palliative care team prepares the family, the patient or family need not become upset. I typically explain to the patient or family in a non-accusatory and non-judgmental fashion that we are going to ask the county social worker to assist them. I tell them that their situation appears to be overwhelming, and that the county social worker may be able to provide them additional resources. Patients and families then welcome the APS worker when she arrives.
5. Most demented patients are not reliable about reporting mistreatment.
Recent research suggests that even demented patients may be able to reliably recount highly emotional events. Emotional memory is stored differently than cognitive memory. A patient may be able to recall highly emotional events even if they cannot remember mundane details, such as what they had for breakfast.
With the advent of hospice and palliative medicine more attention is given to palliative chemotherapy. New chemotherapy regimens are being designed to ‘heal’ rather than ‘cure’, to alleviate symptoms while maintaining the patient’s quality of life.
In the early 1990s the University of Florida developed an ‘all-oral’ protocol for use in refractory / recurrent Hodgkin’s disease. (1) This protocol was based on an earlier European regimen CEP but, as Prednimustine was unavailable in the United States, cytoxan and prednisone were substituted.(2) The resultant all-oral protocol, CCEP, was used with success not only in Hodgkin’s disease but also in refractory / recurrent non-Hodgkin’s lymphoma.(1,3) The protocol is as follows;
Cytoxan 100 mg PO day 1 10
CCNU 80 mg/m2 PO day 1
Etoposide 100 mg/m2 PO day 1 5
Prednisone 60 mg/m2 PO day 1 14
The chemotherapy was cycled every 28 days.
Several palliative lymphoma regimens were developed since but few were ‘all-oral’. A CCEP regimen (using Procarbazine instead of Prednisone) was used in AIDS-related non-Hodgkin’s lymphoma at 6 week intervals. (4) The response rate was 61% with a 39% complete response rate. However the treatment related mortality was high at 11% with myelosuppression being the most frequent and severe toxicity. Similarly, a study in Africa utilizing these agents on different schedules revealed an overall response rate of 78% with an overall survival time of 12.3 months. 33% of these patients with AIDS-related non-Hodgkin’s lymphoma survived 5 years.(5) Another protocol, PEPC, used Procarbazine in place of CCNU and was administered as metronomic therapy.(6,7) The overall response rate was 69% with a 36% complete response rate and a 33% partial response rate. No treatment related deaths were reported though myelosuppression was still a significant factor.
All-oral chemotherapy is useful both in the home and the outpatient setting. A cost analysis of the oral regimen reveals that the oral Etoposide is very expensive making the overall costs seems higher with CCEP when compared to a common intravenous (lymphoma) regimen like CHOP. However, unlike CHOP, CCEP requires no costs of pharmacy preparation, intravenous administration nor the OCN staff / facility necessary to administer it. CCEP also requires no intravenous (port) access and, by dose titration, tumor-effects can be maximized and quality-of-life maintained with myelosuppression and other toxicities kept to a minimum.
The CCEP (Cytoxan, CCNU, Etoposide and Prednisone) protocol shows great promise and should be considered by academic palliative services for study both in Hodgkin’s and non-Hodgkin’s lymphoma. Its efficacy in Hodgkin’s disease is noted in the literature however the results from the University of Florida, for Non-Hodgkin’s lymphoma, were never published. I am an affiliate of the Moffitt Cancer Center (University of South Florida) and have been told by a senior professor that since the agents in CCEP are so commonplace no drug company would ever supply the funding needed for university-level testing. How do you see this protocol proceeding on its own faith and merit? Is there any academic palliative program willing to put forward its own effort, independent of the pharmaceutical industry, to investigate this regimen further?
1. Miller AM, Moreb J, Killeen RB: All-oral chemotherapy in refractory Hodgkin’s disease. Lancet 1991; 337:1408.
2. Santoro A, Viviani S, Valagussa P, Bonfante V, Bonadonna G: CCNU, Etoposide and Prednimustine (CEP) in refractory Hodgkin’s disease. Sem Onc 1986; 13 (suppl 1):23-26.
3. Killeen RB, Marsh RL: 1991. unpublished.
4. Remick SC, McSharry JJ, Wolf BC, Blanchard CG, Eastman AY, Wagner H, Portuese E, Wighton T, Powell D, Pearce T, Horton J, Ruckdeschel JC: Novel oral combination chemotherapy in the treatment of intermediate-grade and high-grade AIDS-related non-Hodgkin’s lymphoma. J Clin Oncol 1993; 11:1691-1702.
5. Mwanda WO, Orem J, Fu P, Banura C, Kakembo J, Onyango CA, Ness A, Reynolds S, Johnson JL, Subbiah V, Bako J, Wabinga H, Abdallah FR,
Myerson HJ, Whalen CC, Lederman MV, Black J, Ayers LW, Katongole-
Mbidde E, Remick SC: Dose-modified oral chemotherapy in the treatment
of AIDS-related non-Hodgkin’s lymphoma in East Africa. J Clin Oncol 2009;
6. Coleman M, Ruan J, Furman RR, Niesvizky R, Martin P, Leonard JP: Oral combination chemotherapy for refractory / relapsed lymphoma with the PEP-C (C3) regimen (daily prednisone, etoposide, procarbazine, cyclophosphamide): low dose continuous metronomic multidrug therapy. Proc Am Soc Clin Onc 2007; 25: 457s (abst 8064).
7. Coleman M, Martin P, Ruan J, Furmann R, Niesvizky R, Elstrom R, George P,
Kaufman TP, Leonard JP: Prednisone, etoposide, procarbazine and
cyclophosphamide (PEP-C) oral chemotherapy regimen for recurring / refractory
lymphoma: Low-dose metronomic multidrug therapy. Cancer 2007; 112(10):2228-2232.