ACS CAN Addresses Controversy Surrounding Opioids
An interview with Mark Fleury, PhD, MS, principal, Policy Development, Emerging Science, American Cancer Society Cancer Action Network, Washington, DC.
Pain as a result of cancer or cancer treatment affects a large denomination of Americans. Depending on the extent of the disease, type of cancer, treatment setting, and other factors, prevalence of chronic pain has been reported in between 15% and 75% of all patients with cancers.1 A recent survey of cancer patients in the United States also revealed that a significant portion of patients diagnosed with cancer will experience pain severe enough to require intervention during the course of their treatment.2
Opioids are often used as the primary method of reducing or managing pain in this patient population. However, these therapies can also be addictive, and the Centers for Disease Control and Prevention (CDC) has declared an “opioid epidemic” in the United States as a result. In 2014, the CDC reports that more than 28,000 people died from overdoses of all drugs in the opioid class, including heroin; this surpassed traffic crashes as the leading cause of accidental death.3,4 The CDC and other prominent health care organizations have since urged physicians to try and curb opioid prescriptions and talk to patients about other pain management options.5 Specifically, the CDC issued guidelines in March 2016 about when to initiate, continue, and stop opioid use in patients with varying conditions,6 but some clinicians have responded with confusion and worry about how the guidelines will influence insurance providers’ coverage of needed medications for patients experiencing intense pain from cancer.7
The American Cancer Society Cancer Action Network (ACS CAN) has publically come out against many of the CDC’s recommendations, and though they agree that opioid abuse and misuse is a problem in the United States, they warn that these guidelines could lead to unintended consequences.8 In particular, ACS CAN has refused to endorse the guidelines due to serious concerns about the “methodology used to develop the guidelines, and the transparency of the entire process,” namely their lack of supporting evidence.9
To learn more about ACS CAN’s position and why opioid usage is such a hotly contested issue, Journal of Clinical Pathways spoke with Mark Fleury, PhD, MS, who is principal of Policy Development and Emerging Science at ACS CAN. Dr Fleury is one of ACS CAN’s policy experts and has worked with the organization for years to help bring patient issues to the forefront of government planning. We asked Dr Fleury about the CDC guidelines regarding opioids and how pain management strategies should be incorporated into clinical pathways.
What kind of pain are patients with cancer likely to face during the course of their treatment?
Broadly speaking, there are two main causes of pain for cancer patients. The first is pain caused by cancer itself. For example, someone with bone metastases experiences a great deal of pain when tumors interfere with normal body function. The second area of pain is caused by treatments for the cancer. An easy one to think about is a mastectomy: when a patient undergoes the surgical procedure to remove breast tissue, they are going to experience pain from that procedure. In addition to surgical pain, many kinds of chemotherapy that are given to patients cause neuropathy, which is a very painful nerve condition. And, of course, a patient may not just experience one of these many types of pain but could have pain from the cancer as well as pain from the treatment used to treat the cancer. Many of these patients also enter care with all of the underlying morbidities that they had before cancer diagnosis. So, you’ll often see a lot of different sources of pain in cancer patients.
What is the role of opioids in treating cancer-related pain?
There are a great many options for treating pain associated with cancer, but one of the primary methods is opioids. In terms of what treatments are given—and as a caveat, I’m not a clinician—it depends on the source of the pain. Sometimes, if it is pain from metastasis, you might give a patient palliative chemotherapy or targeted radiation that will shrink those tumors causing the pain. That is, the treatment is not necessarily used to cure the person’s cancer but can relieve some of their pain. Other methods include physical therapy and behavioral or social care, but opioids are the mainstay and are indicated for many different types of pain. Care should be multimodal though, meaning that the source of pain is not always one simple force, and the decision on which treatment to use should be adapted to patient circumstances.
Why has the use of opioids become such a controversial issue?
Well, it is clear that there is a large public health issue around the use and abuse of prescription opioid medications. There is no question that there is a problem that needs to be addressed. That is the reason behind some government and private attempts to curb use. We share that concern—there is a lot of harm coming from the misuse of these medications. That being said, we worry that policymakers are too focused on those harms. You can create policies that will reduce that harm, but you need to make sure you are not creating policies that simultaneously impede the use of these medications for patients who need them, because they have a very valid use and are effective for many individuals.
So, a better strategy may not be cutting off use but trying to better manage how they are used?
Right. If you wanted to take a simplistic view, the best way to eliminate problems from prescription opioids would be to get rid of prescription opioids. But for years, it was obvious to us that many cancer patients were living and dying with unrelieved pain. We have come a long way since that time, and we fought very hard to make sure patients were getting appropriate pain treatment throughout care. We don’t want to see all that hard-fought progress go backwards.
Can you talk a little bit more about the guidelines issued by the CDC and describe your concerns about these guidelines?
We [at ACS CAN] were asked to look at an early draft of government recommendations on opioid use, and they alarmed us for a number of reasons. The main reason was the lack of evidence on which they were based. The CDC made some really strong recommendations that were not supported by evidence; this is unfortunate, because this area of chronic pain treatment really doesn’t have a good amount of quality evidence and research about what works and what doesn’t. So, while it can be difficult to make definitive judgments in all of these areas, the CDC made some very strong statements. For example, they reviewed the evidence and said there are no clinical trials comparing the use of opioids vs non-opioids for the treatment of chronic pain but still made strong recommendations that non-opioids were the preferred treatment for chronic pain. It is that approach that alarmed us a little bit. We are an evidence-based organization from a policy standpoint and also believe that medicine itself should be evidence-based as well. In 2014, the National Institute of Health tried to tackle this problem, and they gathered experts together and asked what evidence there was around the use of opioids, and it was telling what they said. I often use the following quote from that discussion: “The evidence was insufficient for every clinical decision that a provider needs to make about the use of opioids for chronic pain.” So, basically, what they were saying is that, if you want to follow the evidence in prescribing, there isn’t a lot of it.
You also have pointed out some concerns about how the guidelines differ for patients with cancer and for cancer survivors.
Right. When we talk about pain, we also have to consider how it changes for survivors of cancer. If your treatment is surgical removal of a tumor and there is not follow-up chemotherapy, pain may not start until survivorship. We know that a large proportion of patients continue to be seen by their oncologist after active treatment has ended. They will use their oncologist for pain management in these instances as well.
But, the bigger thing I would point out is that, when we talk about cancer pain, there can be a misconception that a patient is experiencing that pain while they’re being treated for their cancer. There was a study conducted by Miakowski and colleagues and published in Journal of Pain about women with mastectomies, and 25% of them were still experiencing significant pain in their breast 6 months after surgery.10 Three months is typically the dividing line between chronic and acute pain. So, one-quarter of women after their mastectomies experienced chronic pain. The question for someone like that is, do we call that “cancer pain” if it is 6 months after the completion of treatment? Some cancers also require limb amputations, and those obviously can cause a lot of pain.
The reason I bring that up is because many of the policies that are being enacted have carve-outs or special considerations for “cancer pain,” even though it’s never really clear what that means exactly. So, is that woman 6 months out from her mastectomy exempt from certain restrictions? Or is it that the day you get your last treatment for cancer any pain is no longer cancer pain? That’s a real issue only because many of the policies we’re seeing get rolled out want to try and treat cancer patients differently.
So, would you say that cancer survivors are being overlooked or treated differently?
I think that’s the challenge. We brought this up to the CDC, because they exempted kids and exempted people receiving palliative care or undergoing active treatment for cancer, but their definitions were a little bit vague. Their recommendation is that the day you complete cancer treatment, all of these guidelines apply, even if the day before they don’t. That’s challenging because it’s creating this artificial construct over what is really a biological process between one day and another; this goes back to our point that policies must be evidence-based and thoughtful. Creating an arbitrary dividing line does not, we believe, apply to that.
What has been the impact of these developments on patients with cancer-related pain?
The guidelines or recommendations as a whole are really couched as voluntary, but one of the problems—and this is something we raised in our comments—is that we’re concerned these will no longer be voluntary once they start being adopted by state licensing agencies. The legislatures are going to look at these recommendations and put them in legislative language and make them law. And, in fact, since the CDC came out with the guidelines, you’ve seen exactly that happen. There are now state laws modeled after them. And we’ve seen a number of cases where what we predicted is what happened; these voluntary guidelines have started having the force of law or have become a source of regulation. And, really, what it’s doing is making physicians feel like someone is looking over their shoulders—whether it is from a legal or licensing standpoint. That has made them a lot less comfortable prescribing opioids. We really want the physician-patient relationship to be about what is best for the patient, and we feel that creating these medical policies that are not strongly evidence-based is going to lead to people who have legitimate needs for pain relief not being able to access these medications.
Could the incorporation of pain management strategies in clinical pathways improve this management process?
Oh, definitely so. I think they should be an integral part of pathways. Obviously, a lot of the guideline authorship organizations such as the National Comprehensive Cancer Network have a standing pain guideline; they call for pain assessment with every visit and will then walk through all the decision points on how to treat that pain. Many of the American Society of Clinical Oncology’s guidelines include pain management as well. But to take it back to pathways, pain control—and more broadly symptom control—is not just about doing the right ethical thing by patients; it also has been shown to sometimes help patients to live longer and require fewer expensive services such as emergency room admissions. If the idea of a pathway is to optimize the best clinical outcomes, best patient satisfaction, and efficient care, then I think pain and general symptom control would have to be a part of that.
Have the recommendations changed since you issued your feedback?
We had a chance to review an early draft and raised a number of significant concerns with the level of evidence and also some of the processes they were using to develop the guidelines. To their credit, they did respond to criticism and opened up the review process more broadly so that more people had the opportunity to read them and make comments or suggestions. After that, they did make some minor changes, but they basically remained the same recommendations.
In cases where it is appropriate for opioids to be prescribed, are there things that patients or clinicians can do to mitigate the risks associated with opioid treatment that might help to address some of the concerns of the CDC?
Again, with the caveat that I am not a clinician, yes, there are things they can do. Patients, providers, policymakers—we all have a role to play. Opioids do certainly have risks associated with them, but—in oncology especially—we’re used to therapies that come with a lot of risk. A lot of chemotherapies are really toxic, but people take them because there is an associated benefit. Opioids share that characteristic, where they can be beneficial to patients but with some risk. There is even risk when they are being used appropriately, because it still is possible for the patient to overdose. However, I think the harms to society that we are talking about are not really accidental overdose while controlling pain; they are addiction, diversion, and misuse. So, it is important to point out that not many people who are prescribed opioids become addicted. In fact, Cochrane Review puts that rate at around 1%.11 That is important to note. However, there is another survey that looked at recreational opioid users, and 75% of them got the pills they use from someone other than their doctor. So, they obtained them from friends or relatives.12
So how can you mitigate the risk? Well, patients can certainly educate themselves about proper use of opioids and ask their doctors about risk. They can also store them appropriately and make sure to dispose of them when they no longer need them. And doctors can do a lot of the same types of things. They should be counseling patients ahead of time and screen their patients. Of those that do end up developing an addiction, people who have a prior history either from nicotine, alcohol, or other drugs have been shown to have the highest risk of developing a new addiction to opioids. So, if you can identify those individuals, that can help. Almost all states have prescription drug monitoring as well, which can help physicians monitor from where patients are getting their drugs. And, of course, we talked about the policy perspective, but it’s worth pointing out again that the biggest thing I would emphasize is that policymakers need to keep balance in mind when developing policies. It is not just about curbing misuse; it is also about maintaining appropriate medical use.
If you’re going to enact a policy that says a patient can’t get opioids until they have tried other treatments, it doesn’t do much good if a patient doesn’t have good insurance coverage for all of those other treatments. That’s an example of how a policymaker may be well-intentioned but sets the patient up to fail because they cannot access pain treatment. That is the issue we are most concerned about.
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12. Results from the 2014 National Survey on Drug Use and Health: Detailed Tables. Substance Abuse and Mental Health Services Administrative Website. http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.htm#tab6-47b. Published September 10, 2015. Accessed November 9, 2016.