TESTIMONY

of

Dr. Kathleen M. Foley

Senate Committee on the Judiciary
Hearing entitled, “H.R. 2260, Pain Relief Promotion Act”
April 25, 2000


Mr. Chairman and Committee:

I am Dr. Kathleen M. Foley, Attending Neurologist, in the Pain & Palliative Care Service at Memorial Sloan-Kettering Cancer Center and Professor of Neurology, Neuroscience and Clinical Pharmacology at the Cornell University Medical College.

I wish to express my appreciation for the opportunity to speak before this Senate Hearing and to express my concerns about the proposed legislation and my opposition to it.

For the last 25 years, I have directed a program in clinical pain management and research at Memorial Sloan-Kettering Cancer Center. I have chaired two World Health Organization Cancer Unit Expert Advisory Panels that have developed guidelines for the management of cancer pain and for initiatives in palliative care.

Americans deserve humane, compassionate care at the end of life. National initiatives in pain research and education are urgently needed. I thank the authors of the PRPA for attempting to address some of the barriers to inadequate pain management and palliative care.

Yet, I remain concerned that the Pain Relief Promotion Act sends the wrong message to drug regulators, physicians and patients about the medical use of controlled substances. As proposed, the Bill provides insufficient funding to have any “real” impact on pain and palliative care education and training. It does not begin to address the seven recommendations to improve end of life care made by the Institute of Medicine of the National Academy of Sciences in its report entitled “Approaching Death.” (See attached) Lastly, it will have no impact on changing the flawed monitoring process of the Oregon Death with Dignity Act that has prevented a full, open and non-partisan evaluation of assisted suicide practices in Oregon.

The Wrong Message

Pain and palliative care experts have defined clear distinctions between pain management and palliative care, and physician assisted suicide. Yet, it has been the advocates for physician assisted suicide who have used the argument that opioids, such as morphine, kill and to try to relate these practices. Yet, there is a preponderance of evidence that demonstrates that the proper use of opioids in patients with chronic pain, as well as in patients at the end of life, does not hasten their death. There is accumulating data to suggest that the proper use of opioids may in fact prolong their lives.

Studies by Dr. Brescia at Calvary Hospital in New York City show that there is no correlation between the dose of opioids a patient receives in the last weeks of life and the timing of their death. Studies of dying patients who were being withdrawn from respiratory support demonstrate that those patients who received morphine lived longer than those who did not receive morphine. Studies recently published from a series of British hospices show no difference in the time to death between those patients who were sedated to control their symptoms as compared to those patients who were not sedated. Finally, the doses of opioids that are often used to treat patients at the end of life are highly variable. The great majority of dying patients are receiving doses in a range equivalent to what you or I might receive as part of postoperative pain management and these doses are safe and effective. In short, the underpinnings of this legislation are not based on scientific evidence. It would be unwise to institutionalize the myth into law--that pain medications hasten death.

In the last 25 years through the development of scientific guidelines and the natural experiment of treating cancer pain patients and non-cancer pain patients with analgesic drugs, specifically opioids, we have shown that patients can take opioid drugs for months to years and continue to obtain pain relief. We have demonstrated that they do not develop respiratory depression with increasing doses because tolerance occurs to the respiratory depressant side effects. Increasing the availability of these drugs for medical purposes is not associated with an increase in diversion to an illegal market. Yet, lack of knowledge about pain assessment and treatment, the use of analgesic drugs, and the control of symptoms in the dying coupled with a strong regulatory environment have led to the significant undertreatment and underassessment of patients with pain, particularly at the end of life.

Working with Mr. David Joranson and Dr. June Dahl at the University of Wisconsin and with many others, we have advocated for a balanced drug policy to assure that opioid analgesics will be available for legitimate medical purposes. We have also worked with the International Narcotics Control Board who has strongly urged its member countries, including the U.S., to place a high level of importance on the medical use of opioids for the treatment of patients with pain.

The PRPA, by expanding the authority of the Controlled Substance Act, will disturb the balance that we have worked so hard to create. Physician surveys by the New York State Department of Health have shown that a strict regulatory environment negatively impacts physician prescribing practices and leads them to intentionally undertreat patients with pain because of concern of regulatory oversight.

In the last five years, there has been increased attention to the inadequate care of patients at the end of life, and to the inadequacy of pain management in patients throughout the course of their medical illness. Five studies have consistently shown that we have a health care system that prevents patients from obtaining appropriate pain assessment and treatment and appropriate palliative care. These studies show that 37% of children with cancer in the last days of life were inadequately treated for their pain by parent report. Recent data from nursing home surveys demonstrate that 40% of elderly cancer patients have pain but less than 25% are receiving any form of analgesic drug therapy. Minorities are particularly impacted by the undertreatment of pain and lack of access to palliative care. Studies show that minorities are undertreated for their postoperative, traumatic, and cancer pain. Complicating this undertreatment is the lack of availability of opioid drugs in pharmacies that serve minority neighborhoods. This lack of access leads to needless suffering. Finally, the SUPPORT study of 10,000 seriously ill hospitalized patients demonstrated that 50% have significant pain in the last days of life.

I am emphasizing these studies only to suggest that the current Pain Relief Promotion Act will do little to alter the current system of care that impedes particularly vulnerable populations such as children, the elderly, and minorities from receiving adequate pain management and palliative care.

Insufficient Funding

The PRPA and the Hatch amendments establish a program for pain and palliative care research and quality within the Agency for Healthcare Research and Quality “to develop and advance scientific understanding of palliative care and to collect, disseminate and make available information on pain management, especially for the terminally ill, professionals and the general public.” This is clearly a laudable endeavor. However, we have in place sufficient guidelines for pain management that have already been issued by the Agency for both acute pain and chronic cancer pain. The problem is not a lack of guidelines, or a lack of information but an inability to implement the information that we currently have into practice. This requires not only the training of health care professionals and the public but the provision of payment to physicians for their services and payment for the costly prescription drugs.

The PRPA authorizes $5 million dollars for a Health Resources and Services Administration grants program. This is a small amount of money to create an enduring change for the 50 million Americans who suffer with chronic pain, and an equal number who have episodes of acute pain, and the 2.4 million Americans who die each year.

What the PRPA does not include is funding for demonstration projects that will put into practice pain management and palliative care programs. For example, demonstration projects that will evaluate how to bridge the gap between palliative care and hospice care programs; demonstration projects that will support role models within institutions such as the VA and PDIA Faculty Scholars Program.

What is needed in every community hospital is an expert physician and nurse who can serve both as role models and resources to their peers and to patients about appropriate pain management and palliative care.

Lastly, the Hatch amendment has suggested the creation of “The Decade of Pain Control and Research” beginning in the year 2001. I want to thank Senator Hatch for his advocacy for pain patients, but to create an initiative without an implementation process and an appropriate funding stream is an empty promise to patients suffering with pain.

There is currently no center on pain research at NIH. There is not even an office to coordinate pain research initiatives. There is no external advisory board to provide input and oversight to pain initiatives. The need for a coordinated, focussed effort with strong leadership and an external advisory board has been strongly advocated by the pain community but has not been implemented at a governmental level and this Bill fails to respond to this need.

In short, this proposed legislation does not adequately respond to the Institute of Medicine recommendations to improve end of life care and falls significantly short of institutionalizing national programs in pain relief and palliative care.

The Oregon Situation

If this Committee wishes to address its concerns about physician assisted suicide in Oregon, it should recognize that it is barbiturates, not opioids, that are currently being prescribed to aid patients in death. Barbiturates are not used in pain management because they are ineffective as analgesics.

The current environment in Oregon has suppressed open discussion and limited the ability to evaluate whether Oregonians do, in fact, receive quality end-of-life care. The current monitoring process is flawed because it only interviews physicians who have aided patients in death, thereby devaluing the medical decisions of physicians who have refused to assist patients in suicide.

In closing, as you consider this legislation, it is important to recognize that proposals that are well meaning and well intentioned should have as their first priority the goal to improve pain management and palliative care for those who so desperately need it.

INSTITUTE OF MEDICINE
RECOMMENDATIONS ON THE CARE OF PATIENTS AT
THE END OF LIFE

From: Approaching Death

RECOMMENDATION 1: People with advanced, potentially fatal illnesses and those close to them should be able to expect and receive reliable, skillful, and supportive care.

RECOMMENDATION 2: Physicians, nurses, social workers, and other health professionals must commit themselves to improving care for dying patients and to using existing knowledge effectively to prevent and relieve pain and other symptoms.

RECOMMENDATION 3: Because many problems in care stem from system problems, policy-makers, consumer groups, and purchasers of health care should work with health care practitioners, organizations, and researchers to

strengthen methods for measuring the quality of life and other outcomes of care for dying patients and those close to them;
develop better tools and strategies for improving the quality of care and holding health care organizations accountable for care at the end-of-life;
revise mechanisms for financing care so that they encourage rather than impede good end-of-life care and sustain rather than frustrate coordinated systems of excellent care; and
reform drug prescription laws, burdensome regulations, and state medical board policies and practices that impede effective use of opioids to relieve pain and suffering.

RECOMMENDATION 4: Educators and other health professionals should initiate changes in undergraduate, graduate, and continuing education to ensure that practitioners have relevant attitudes, knowledge, and skills to care well for dying patients.

RECOMMENDATION 5: Palliative care should become, if not a medical specialty, at least a defined area of expertise, education and research.

RECOMMENDATION 6: The nation’s research establishment should define and implement priorities for strengthening the knowledge base for end-of-life care.

RECOMMENDATION 7: A continuing public discussion is essential to develop a better understanding of the modern experience of dying, the options available to patients and families, and the obligations of communities to those approaching death.

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