This is the first in a series of Forum interviews with PRF science advisors.
Kathleen Foley, MD, has been caring for patients with cancer pain for over 40 years. Since 1974, she has been an attending neurologist at Memorial Sloan-Kettering Cancer Center in New York City, US, where she founded the first designated pain service in a cancer setting in the United States. As medical director of the International Palliative Care Initiative at the Open Society Foundations for the last decade, she has worked to promote pain and palliative care around the world. Throughout her career, Foley has pioneered the assessment and treatment of patients with pain and the development of initiatives to help governments and international organizations improve care. In a phone conversation with the PRF's Megan Talkington, she shared her concerns about policies and attitudes that hinder effective treatment, discussed research needs for the pain field, and highlighted the advances that give her hope. The following is an edited transcript of the conversation.
What are the biggest changes you have witnessed over the years in the treatment of cancer pain?
The real revolution in treatment came in the 1980s with the recognition that cancer pain was a significant public health problem, and that pharmacologic management was the mainstay of therapy. That led to a targeted effort by the World Health Organization (WHO) to advocate that pain relief must be a major component of any cancer control program, and that the management of cancer pain fit into a broader approach of comprehensive care called palliative care. Framing cancer pain treatment within a broader approach has been an enormous advance that continues to the present day.
But, while there has been great progress in identifying the pain syndromes that patients with cancer have, and developing approaches for managing them and systems of care, the evidence base still suggests that cancer pain is undertreated. Looking at the United States as an example, even now, up to 50 percent of cancer patients remain undertreated for their pain, based on a variety of new surveys.
It’s not simply a problem of assessment. In the US, we have made a major move forward in making pain the fifth vital sign that is recorded when the patient is seen in the hospital, the clinic, or the emergency room. But we continue to see large populations of patients who are not getting full access to pain treatments. The barriers exist, they continue to exist, and there is not always a clear understanding of why.
Recently, with the increase in prescription opioid use for patients who do not have cancer, and the increase in misuse, abuse and overdose in the non-patient population, there has been a backlash against the cancer patient. In the past, the cancer patient was seen as sacrosanct in the debate on who could be prescribed opioids for their pain. Opioids were accepted by the WHO and most national guidelines as the “mainstay” of therapy. Now, because of the prescription drug abuse issue in the US, their use in cancer pain management is being debated again. It is a dilemma, and there is a real push back on the use of opioids even for cancer patients.
What about the situation in other countries?
When we look at this issue internationally, we see significant regulatory barriers to the global availability of opioids to treat cancer pain. The WHO estimates that five million cancer and HIV/AIDS patients who are dying each year lack access to these pain-relieving drugs. Ukraine is an example of a country where regulatory barriers impact cancer pain treatment. The government set the dose that cancer patients with pain could receive at 50 mg of injectable morphine a day. Well, there’s no evidence base to this regulation. The pharmacologic evidence is that opioid responsiveness varies among patients, and that opioids need to be titrated to the individual patient.
Human Rights Watch wrote a lengthy report on the situation in Ukraine. They interviewed physicians throughout the country and showed how these draconian policies interfere with patient access to pain relief. And the physicians face an ethical dilemma: remain loyal to the government, or to their patients? For the most part, none of them will go against the government, so patients suffer. It is the danger of policies that are not evidence-based. Ukraine is now working hard to make oral morphine available—rural areas of the country have none at all—and to change the legislation.
Aren’t similar restrictions being put in place in the US?
Absolutely. The state of Washington has set a policy that, if patients are taking more than 120 mg equivalents of morphine a day, they need to be evaluated by a pain consultant. I'm an advocate for patients seeing pain experts, but setting those kinds of limits, when there isn't a clear evidence base, is problematic.
This magical number, 120, is based on studies by Dr. Jane Ballantyne [now at the University of Washington, Seattle] and others that suggested that higher doses lacked efficacy with long-term use and may have adverse effects. But the evidence is retrospective and the problem is much more nuanced, so a lack of science is currently driving drug and pain policy.
Anecdotally, the nurses I work with are very concerned that, because Medicaid patients need approval for their drugs on a monthly basis, it is increasingly difficult for them to access opioids. Often it is just assumed that these patients seek drugs for reasons other than pain.
For a long time, I have advocated for balanced policies where we professionally educate healthcare workers on how to use these agents properly, and have policies that protect them so they can prescribe the drugs safely and effectively. But now the pendulum is swinging toward a very aversive attitude to these drugs. What was happening in the 1970s, when I started working in this field, is coming back in 2012.
Are policy issues mainly to blame for the high rate of undertreated cancer pain in the US?
In the US, the issue of undertreatment is more complicated. We need to get a better handle on the issues. Our ability to treat cancer more effectively—for the patient with breast, prostate, or lung cancer—has forestalled many terrible chronic pain problems. But in the case of ovarian, pancreatic, or cervical cancer, we are not as far along, and other problems, like progressive bony metastases and neuropathic pain, remain intractable.
When we developed ways to assess cancer pain, we defined three major categories: patients who had pain related to their tumors, those who had pain related to their treatment, and those who had pain independent of either tumor or treatment. I was involved in those studies in the late 1970s and early 1980s. The majority of patients fell into the first two categories. Now we see many more people with pain associated with treatment, as opposed to the tumor itself. Peripheral neuropathy from chemotherapy is a major pain issue. But no one has studies to document if there is a shift from the tumor-related pain to more treatment-related problems, or to more chronic pain problems independent of cancer.
We also now have a growing population of survivors, who have had major surgical procedures, or previous chemotherapy, or reconstructive surgery, that may have left them with a neuropathic pain syndrome. Depending on what survey you read, 30 to 50 percent of cancer survivors have persistent pain. Identifying what pain syndromes are in the survivor population is also important, and there is a need for careful categorization of the pain syndromes in survivors.
The hard part for those survivors is the meaning of pain. We see this repeatedly in patients—with new onset of pain there is immediate and great concern that their tumor has returned. We are seeing people who are developing radiation-induced bone lesions that are associated with pain. The lesions initially look like recurrent tumors, when, in fact, they are treatment-related injuries. It’s important to identify the cause of pain for these patients.
What efforts to improve pain care are you most hopeful about?
The introduction of palliative and hospice programs to prisons has been a big advance. One of the best examples is the state penitentiary in Angola, Louisiana, US. This is a 5,000-inmate prison, where 85 percent of the population will die there from aging or diseases like cancer and HIV. The prison instituted a hospice program, in which other inmates serve as volunteers, to provide pain management and psychological and spiritual support. The Open Society Foundations have made a very compelling video about this program.
I am positive about the hospice and palliative care movement in the United States. The ability to provide effective pain management to patients who are dying at home has been an extraordinary advance. Hospice care is the one way that patients with advanced illness can be cared for in their homes and have access to healthcare professionals who know how to treat pain and can prescribe the right drugs for those patients. But again, in the last few years, there have been attacks on that system, because of concerns about the drug formulations, etc.
I am also positive about efforts to improve pain management in nursing homes. There is a strong movement to make opioid drugs available in a nursing home setting, but to do that we need nurses who know how to use the drugs properly, and nursing homes need to be equipped with safes to store the drugs. With drugs that have the potential for misuse or abuse, having healthcare professionals who are educated in their use would be quite helpful. We don't have that. We have initiatives beginning in nursing homes to improve access to pain care, but there is a long way to go.
Do you think that gaps in education are a major issue?
From 1997 to 2001, I was involved with three reports [for the Institute of Medicine (IOM) of the National Academies, US]: Approaching Death, When Children Die, and Improving Palliative Care for Cancer. Each one strongly emphasized healthcare professionals’ lack of education and the need for training to treat pain. We concluded that we had identified the enemy, and it was we, the physicians. The report about kids was the saddest—it concluded that children receive neither competent nor compassionate care at the end of life.
Today, there remains a significant lack of integration of pain education in medical and nursing schools. The new IOM report discusses this. It’s not simply doctors’ and nurses’ inability to assess patients with pain, but their lack of understanding of how to use drugs properly, and how to use cognitive behavioral, stress reduction, and rehabilitation approaches.
What about research? In what areas is new information most desperately needed?
We need better drugs—ones that don't cause respiratory depression, and that are better targeted to specific types of pain, such as that seen in arthritis, and to different types of neuropathic pain. We also need drugs that don’t carry the potential for misuse. To achieve these outcomes will require an extraordinary research effort.
In terms of research funding, in 2005, a group of us from the United States Cancer Pain Relief Committee supported a study of the U.S. National Institutes of Health (NIH) funding mechanisms. We found that less than 0.5 to 1 percent of NIH funding was spent on pain [Bradshaw et al., 2008], and this has been confirmed in other studies. There is not a lot of money going into research for this problem.
Another issue is that the number of young investigators pursuing a career in pain is small, because the NIH does not advocate for them. In no way do I dismiss the wonderful research that some people are doing, but there are not enough of these investigators. In addition, we lack major centers of excellence around the country where crosstalk can occur between basic researchers and clinicians. The lack of support for these kinds of organizational efforts paralyzes the field, and I'm very concerned that we are not going to move things forward for patients because of the lack of a strong effort led by the NIH, where pain is an orphan.
Are there clinical areas where researchers need to focus more attention?
We need to look at systems of care, very much the way we have created mental health programs that provide drug therapy, psychosocial support, psychiatric care, and family therapy. We need to do that for the patient with chronic pain. We need to research those types of programs and see what works best by looking at the team approach. Right now, a patient with chronic pain sees a family doctor, and maybe gets sent to a rehab place for some limited treatments, or to an anesthesiologist once. Nothing is coordinated. There is no social worker who can help the patient with cognitive behavioral approaches and addressing the meaning of the pain. We don't have the palliative care approach for the chronic pain patient—we don't have an interdisciplinary team that is supported to do this work, talk to each other, and study it.
If we think that pain is a biopsychosocial problem, then we have been looking at just one piece of it—the drug aspect—and poorly. That's why the IOM called for a cultural transformation. To my mind, you can't have a cultural transformation if you don't know what the evidence is. So we need a scientific revolution. We need to be able to say, if you put these people in a group and follow them over a period of time, and if you have one doctor treating them, helping them navigate the system, and you remove incentives for doctors to operate on them or incentives for people to give them nerve blocks, but rather give incentives for a holistic approach, would that make a difference? But we don't seem to want to create those kinds of systems, support them and look at them as demonstration projects. That's a kind of research that would be helpful.
Another important effort would be to collect prospective data. Rather than using retrospective studies, we need to prospectively look at the population of patients that is taking pain drugs and begin to tease apart in real time what the issues are. There are huge databases of patient information, and to the credit of Kaiser and other large insurance groups, they are looking at this and coming up with good models of how to provide care for these individuals, rather than stigmatize them. Chronic pain patients have significant comorbidities, and they need coordinated care.
We've been quite successful at advancing pain care within oncology, for patients at the end of life. But the broader issues of pain are really significant now in the US. I feel enormously concerned. I had an opportunity to review the IOM report, and I give them credit for categorizing the issues, but the problem is so serious—what the IOM said, we have been saying since 1975, and no one has done anything.
We are better at giving pain relief to the dying than we are to the living. Everyone agrees that we shouldn’t deny a cancer patient pain relief, but we would deny therapy to a patient who will live with pain for the next 20 years? It doesn't make sense that a patient should be dying to receive good pain relief.
Tell me about the projects you’ve been working on at the Open Society Foundations.
Our major foci are Africa and Central and Eastern Europe. We are working to change government policies in order to make drugs available, and to increase support for palliative care for patients with cancer and AIDS, the elderly, and children. We’re also looking at model programs and observing what is effective.
We are also working to develop palliative care leaders around the world, and through the International Palliative Care Initiative, we support a robust palliative care leadership program directed by the San Diego Hospice. To date, there are 44 leaders, from over 30 countries, who we hope will lead future efforts in their respective nations.
In addition, along with the Pain and Policy Studies Group at the University of Wisconsin, we are supporting International Pain Policy Fellows who are learning how to assess their countries’ policies related to opioid availability and how to work with their governments to make legislative changes. There have been some really nice successes in Guatemala, Colombia, and Nepal, to name a few.
We are also supporting the development of some really extraordinary pain and palliative care programs for children with advanced cancer and AIDS in South Africa, and more globally, by the International Children’s Palliative Care Network.
You have been learning about pain, and treating it, for a long time. I'm curious how your ideas about pain have changed over the years. Has your thinking undergone any important shifts?
Because my focus is on the cancer pain population, I see people with a medical illness where there is a very clear, observable cause for their pain. Those patients taught me so much about the pain issue. For example, in the 1970s and early 1980s, when we had patients with significant pain problems and all their X-rays were negative, we immediately wanted to attribute their pain to their psychological state. This was in the days before CT scans, before MRI. Then we had the opportunity to use new imaging techniques—we would do an MRI and see a huge tumor sitting behind the sternum. Because we couldn't see the tumor on an X-ray, we thought the patient was psychologically impaired. That humbles you.
When it took us weeks to figure out the cause of their pain, the patients began to think it was all in their heads. We thought, this is just depression, this is just dysfunction, this is just a malingerer. And then we would see their tumor. It really humbles me about who has pain, how they complain about it, and what it means.
At the same time, all of this has taught me that drugs are not the answer. They are part of the answer. Patients have very complicated conditions in which pain is only a piece of it. That's why comprehensive systems of care like palliative care programs—where you address not only patients' pain but their psychosocial and spiritual distress, and take care of their families—are so important to effectively treat the symptoms these patients have.
Lastly, I see extraordinary individuals who live with pain every day. I have a lot of respect for their resiliency in trying to function as best they can when they are disabled in many ways. They deserve a lot of respect, and not to be stigmatized as we often want to do.
Thank you so much for speaking with the PRF.
PRF Related Content:
News: Lancet Review: Most Chronic Pain Treatments Don’t Work (7 July 2011)
News: IOM Report Calls for Cultural Shift in Pain Treatment, Prevention, Research (1 July 2011)
View Kathleen Foley’s profile on Pain Research Forum (requires member log in)
Foley KM. How well is cancer pain treated? Palliat Med. 2011 Jul;25(5):398-401.
Portenoy RK. Treatment of cancer pain. Lancet. 2011 Jun 25; 377(9784):2236-47.
TREATTHEPAIN.COM: Global Access to Pain Relief Initiative
(see also GAPRI video at Union for International Cancer Control website)
Other Forum Interviews:
Pain and Its Control: A Conversation with Allan Basbaum (6 June 2012)