The following is from Bob Twillman, Ph.D., FAPM, Director of Policy and Advocacy for the American Academy of Pain Management (AAPM). The foundation supports the AAPM in their efforts to advance patient-centered federal and state pain policies to ensure balanced legislation and regulations.
On Friday, January 25, the US Food and Drug Administration’s (FDA’s) Drug Safety and Risk Management Advisory Committee voted 19-10 to recommend that FDA move pain medications containing hydrocodone in combination with other medications (most commonly known as Vicodin, Lortab, or Norco) from Schedule III to Schedule II under the Controlled Substances Act. This vote is the culmination of action that began in 1999, when a citizens’ petition was filed with the US Drug Enforcement Administration (DEA) requesting that such a move be made. The FDA now has to decide whether or not to follow the committee’s recommendation—they are not obligated to do so, but frequently do.
Should hydrocodone-containing combination medications be moved to Schedule II, it would mean that prescribers could no longer telephone the pharmacy to issue a prescription for the medication, and an electronic or written prescription must be used instead. Prescription refills would be prohibited, meaning that a new prescription would be needed when an old prescription runs out (most often monthly). The committee’s vote reflects its opinion that hydrocodone is just as potentially addictive as other Schedule II medications, which include morphine, oxycodone (the opioid in OxyContin and Percocet), fentanyl, methadone, and others—an opinion with which most medical professionals likely would agree.
This move comes two weeks before another meeting that FDA will convene, focused on the available scientific evidence related to the FDA-approved indication for all opioid pain medications. A group of physicians concerned about prescription drug abuse has petitioned FDA to change the label so that the official FDA policy, with respect to treatment of “non-cancer pain”, would be that opioid pain relievers should be used 1) only for severe pain (the current indication is for moderate-to-severe pain); 2) in doses no greater than the equivalent of 100 milligrams of oral morphine per day; and 3) for no longer than 90 days, when used daily. The petitioners (who played a key role in moving the committee to vote for rescheduling hydrocodone) argue that there is very little evidence that opioids work for non-cancer pain in general, and that at high doses and over long periods of time, the risk of adverse events, including addiction, is so high that opioids should not be used under these circumstances. I have previously addressed the petitioners’ arguments.
While the petitioners focus on “non-cancer” pain in their request, I believe there are also direct implications for people affected by pain related to cancer. In fact, at the upcoming meeting, I will be telling the committee that I do not believe there is a physiological, pharmacological, or even philosophical, basis to distinguish between “cancer pain” and “non-cancer pain”. When I began working in cancer pain management 20 years ago, there was a school of thought that people with cancer generally had a limited lifespan, so didn’t need to be concerned about the long-term consequences of using opioid pain relievers; there was no such thing as “chronic cancer pain”. However, as survival rates have improved due to the introduction of increasing toxic chemotherapeutic agents, we have begun to see cancer survivors living many years with significant pain resulting from their treatments. At what point does that cease being “cancer pain” and become “chronic non-cancer pain”? At what point will regulators and insurance companies decide that they don’t want to pay for treating that pain, and begin calling it “non-cancer pain” so they can limit treatment?
I’ll never forget one cancer survivor with pain, with whom I worked in our cancer pain management clinic. Gina was a bright, happy 17-year-old when we first saw her. She was 5 years past the diagnosis of acute lymphocytic leukemia, for which she had received an allogeneic bone marrow transplant. After the transplant, she developed graft-versus-host disease, which was treated with steroids, which, in turn, gave her avascular necrosis in both hips and both shoulders. She was in excruciating pain until we finally managed to get it under control with high doses of opioid pain relievers. Gina remained on those high-dose opioids for nearly a decade, working, getting married, living a full and active life, until she was finally able to undergo 4 joint replacement surgeries, at which time she stopped taking the pain medications. So, I ask you—did Gina have “cancer pain” or “non-cancer pain”? Her pain was not directly caused by her cancer, but rather by a treatment for a complication of her cancer treatment. And how, exactly, should her treatment have been different if she had developed avascular necrosis from another cause? As the distinctions blur, we increasingly move in the direction of having one set of policies that affect all people with chronic pain, whether originating with cancer or not.
All of this effort has as its goal reducing the supply of opioid pain relievers prescribed by healthcare professionals. Those supporting this effort point to an apparent correlation between increasing sales of opioids and simultaneous increases in overdose deaths in which prescription opioids are one component. They point out that over 16,000 Americans died under such circumstances in 2009, the last year for which data are available, and that this number exceeds all other causes of accidental death, including motor vehicle crashes. They say, in essence, that there is a simple way to bring down overdose deaths, and that is by reducing the supply of medications by imposing stricter requirements for prescribing them. In my opinion, that is a very simplistic view of a very complicated problem, and is a blunt-instrument intervention that is about as likely to hurt people with pain as it is to reduce overdose deaths.
The concern for people with pain is that efforts to limit medication supplies will make it more difficult for them to access the medications they need to achieve good pain control. It’s really like the aphorism, “a rising tide lifts all boats” and its opposite, “an ebbing tide lowers all boats”: Just as an increasing supply of opioids over the past decade has increased both proper use to help people with pain and the misuse of opioid pain relievers, so, too, will a decreasing supply make it harder for people with pain to access the medications while simultaneously decreasing access for those who misuse them. That is why such a blunt instrument approach is problematic. We need to find a way to decrease access for those misusing the medications while maintaining or even increasing access for proper use.
I think those trying to control prescription drug abuse by addressing only the “supply side” of the supply-and-demand equation are missing the boat entirely. If you are trying to control the abuse of an illicit drug (e.g., heroin), then completely eliminating the supply is an appropriate goal, however unattainable that goal might be. But when the drug of abuse is a medication that millions of people need to treat pain, eliminating the supply is an inappropriate goal, and focusing efforts on that inappropriate goal produce the inappropriate results outlined above. We’ve also observed that supply-side interventions tend to produce a “squeezing the balloon” effect—when you clamp down on the supply of one drug, the abuse of another, similar, drug increases. For instance, in the past several months we have seen numerous reports of increased heroin abuse as efforts by the DEA and others have caused supplies of oxycodone to plummet in Florida and elsewhere. The number of people abusing drugs in America seems to have been stable since we began measuring it early in the 20th century; it’s just the drugs of choice that have changed.
We will only make progress in addressing this problem when we begin paying attention to the “demand side” of the equation as well, i.e., when we begin to treat addiction as a public health problem, and to intervene in ways that are compatible with that view. That’s exactly what the White House Office of National Drug Control Policy has been trying to do for the past three years, and they have been appropriately praised for their approach. Even President Nixon, at the start of the War on Drugs in the late 1960s and the early 1970s, recognized that he needed to dedicate 2/3 of his drug control budget to increasing substance abuse treatment. You see, if we go back to the balloon analogy, what drug abuse prevention and treatment does is to let the air out of the balloon—it decreases the number of people engaging in the behavior we want to end. And guess what? There is NO downside for people with pain when we do this; they should see no decrease in their access to the medications they need.
I think THE model for this idea is Project Lazarus, a community-focused drug abuse prevention and treatment project started in North Carolina. Project Lazarus engages communities in educational efforts and provides naloxone for people to administer if they encounter someone in the throes of an opioid-related overdose. At the same time, Project Lazarus staff and others also educate healthcare providers about good pain care, substance abuse screening, and how and where to refer people for substance abuse treatment. From 2008 through 2011, Project Lazarus has produced an astounding 82% decrease in overdose deaths related to prescription opioids, while simultaneously the amount of opioid medication prescribed has decreased by only 1%. Everyone who understands the sociocultural and medical factors underlying prescription drug abuse should recognize that this kind of comprehensive, community-based approach is what will be required to successfully address two concurrent and somewhat opposed public health crises: prescription medication abuse and chronic pain.
Government statistics tell us that about 12 million Americans aged 12 and older misuse prescription opioids in a given year, while the Institute of Medicine reports that at least 100 million American adults have chronic pain. Prescription drug abuse costs an estimated $70 billion per year, according to Money magazine, while the Institute of Medicine estimates the cost of chronic pain at between $560 and $635 billion per year. Clearly, these are two major public health crises, with huge financial costs to society. Often, people view the situation as one in which you can’t solve both problems because what you have to do to fix one makes the other worse. As long as we continue approaching this complex problem with simple, blunt-instrument interventions like rescheduling hydrocodone-containing medications instead of with sophisticated, complex, surgical-instrument interventions, that view is likely to be borne out. And I believe that is exactly what will be demonstrated if FDA follows the advice of its Advisory Committee. I hope I’m wrong about that, but I’m afraid I won’t be.