The Debate: Are Laws Controlling Opioid Painkillers Hurting People in Pain?

Are Laws Controlling Opioid Painkillers Hurting People

As the U.S. witnesses the ongoing devastation of the opioid epidemic — increasing rates of misuse, abuse, dependence, addiction and overdose from prescription painkillers and heroin — federal, state and local governments are ramping up initiatives to stop the problem in its tracks.

Some believe that laws limiting prescription painkillers — designed to curb the supply of narcotic painkillers — are preventing people with chronic pain from getting the relief they desperately need. Others see these regulations as crucial to preventing more addiction and overdose deaths from these powerful medications, which include hydrocodone and oxycodone, among others. asked Bob Twillman, PhD, executive director of the American Academy of Pain Management, and Andrew Kolodny, MD, chief medical officer at Phoenix House, in New York City, to share their expertise on either side of this complex, controversial issue.





DrBobTwillmanBob Twillman, PhD, is the executive director at the American Academy of Pain Management, based in Sonora, California, an organization that advocates for an integrative approach to managing pain. Dr. Twillman is also responsible for overseeing the Academy’s response to federal and state pain management policy developments and chairs the Prescription Monitoring Program Advisory Committee for the Kansas Board of Pharmacy. He received his doctorate in clinical psychology at the University of California in Los Angeles.

Dr. Twillman: Yes, laws regulating opioid painkillers are keeping people who need pain relief from getting it.

“I believe laws, regulations and guidelines aimed at reducing prescription drug abuse are, indeed, keeping people with a legitimate medical need for opioid analgesics from getting them. It’s hard to measure the extent to which this is occurring because it would entail measuring services that are not delivered, but from the volume of calls received by the American Academy of Pain Management and many patient advocacy organizations, I have no doubt that access to medications is a problem for some patients. I’ve talked to people with pain who have been unable to fill their prescriptions despite visiting as many as three dozen pharmacies. The problem has gotten so bad in Florida that both the Attorney General’s office and the state Board of Pharmacy are taking steps to address it.

Part of the reason this is happening, I think, is because we are taking an overly simplistic approach to a very complex problem. When we ask, ‘how can we reduce the supply of prescription opioids?’ we’re asking the wrong question; the right question is, ‘how can we reduce the supply of excess prescription opioids?’ Naturally, that complicates things because we first have to define ‘excess’ and then know when that’s what we’re dealing with. While opioid analgesics are not the appropriate treatment for all people with chronic pain, there is a subgroup that needs them to achieve good pain control and improved function. The NIH and other agencies have noted that we lack evidence regarding the overall effectiveness of long-term opioid therapy, but we need to remember that the absence of evidence is not evidence of absence; i.e., that lack of evidence does not mean that long-term opioid therapy is not effective for anyone with chronic pain that is not related to cancer or end-of-life situations. Anti-opioid advocates who call for a broad-brush approach that would deny opioids to people outside of these specific circumstances are being overly simplistic in their approach and, as a result, creating the potential for people who benefit from opioid therapy to be harmed.

When we have the simple goal of reducing prescription opioid supplies, then we run the risk of restricting access to them for both people who misuse and abuse them as well those who use them to relieve their pain. It’s rather like the inverse of the saying ‘a rising tide lifts all boats.’ Yet, whenever we see a new policy instituted, the primary outcome measure is almost invariably the degree to which medication dispensing is reduced, with no attempt to discern how much of that reduction affected people who should not have been affected.”

DrAndrewKolodnyAndrew Kolodny, MD, is the chief medical officer at Phoenix House, a national, non-profit addiction treatment agency. Before joining the Phoenix House team, Dr. Kolodny served as chair of psychiatry at Maimonides Medical Center, in Brooklyn, New York. He co-founded Physicians for Responsible Opioid Prescribing, an organization that promotes responsible opioid-prescribing practices. Dr. Kolodny previously worked for the New York City Department of Health and Mental Hygiene as the Medical Director in the Office of the Executive Deputy Commissioner.

Dr. Kolodny: No, laws regulating opioid painkillers are not preventing patients with chronic pain from accessing safe and effective treatment. Opioid painkillers are not an appropriate option for most patients with chronic pain.

“I think the question you’re really asking is, ‘Are new laws about opioid painkillers preventing patients from accessing opioid painkillers?’ There is a problem with your question. It equates relieving pain with taking opioids. Although opioids can help ease suffering at the end of life and can relieve pain when used on a short-term basis, they don’t work well when taken regularly. Long-term use may be more likely to harm patients than help them because opioids, a class of drug that includes heroin, are highly addictive and because their ability to relieve pain declines over time. Long-term use can even make pain worse, a phenomenon called hyperalgesia. A recent report from the federal government’s Agency for Healthcare Research and Quality concluded that the chronic use of opioids, especially at high doses, is dangerous and evidence of effectiveness is lacking.

The opioid lobby, which includes opioid manufacturers, wholesalers, retailers, pill mills and industry-funded pain organizations, would like policymakers and the public to believe that opioid harms are limited to so-called ‘drug abusers’ and that millions of patients with chronic pain are helped by opioids. This is totally false. In fact, it is people who suffer with chronic pain that have been disproportionately harmed by opioid overprescribing. A study of opioid overdoses in Utah found that 92% of the people who had died from a prescription overdose in 2008 were receiving legitimate prescriptions for chronic pain. And the demographic group that has seen the greatest increase in opioid overdose deaths is middle-aged women, a group that disproportionately receives treatment for chronic pain.

The Centers for Disease Control (CDC) has been very clear about the cause of our epidemic of opioid addiction and overdose deaths. The CDC has demonstrated that as opioid prescriptions began to skyrocket in the late 1990s, it led to parallel increases in addiction and overdose deaths. The CDC’s message is clear: Reductions in opioid prescribing are required to bring our epidemic of opioid addiction under control. With only 5% of the world’s population, the U.S. is consuming more than 80% of the world’s oxycodone supply and more than 99% of the hydrocodone supply. And despite the enormous public health price we’re paying for our overconsumption of opioids, there is not one shred of evidence that we do a better job of treating pain than in Western Europe, where opioids are prescribed much more cautiously.

Not surprisingly, the opioid lobby does not like the CDC’s message and does not want to see prescribing reduced. They have even attacked the CDC for suggesting that overprescribing is the root of the problem. An excellent example of the opioid lobby’s antagonism toward the CDC can be found in the [2011] editorial titled ‘A Call To Stop The “Epidemic” Of Opioid Pain Medicine Overdoses,’ written by Bob Twillman in a Capitol Hill newspaper.

I do believe that there are patients on high daily doses of opioids who are having a harder time these days getting doctors to continue prescribing for them. But new laws have not caused this. What is happening is that the medical community is starting to understand that long-term opioids are not safe or effective for common conditions like low back pain, fibromyalgia and chronic headache. Doctors who have lost patients to overdose deaths may feel especially reluctant to continue prescribing opioids for chronic pain. These patients are in a difficult situation because coming off of opioid painkillers can be very difficult, even in patients who are motivated to come off.”

Q: Is there a way we might use laws or other policies to curb opioid overdose and abuse without giving pain patients fewer options for managing their pain?

Dr. Twillman: “I think there are several things we can do to strike this peculiar kind of balance. First, we need to increase our emphasis on addressing the demand side of the supply-and-demand equation involved in drug abuse, i.e., we need to increase availability of treatment resources for people with a substance use disorder and invest in effective primary prevention. As long as our entire focus is on curbing supplies, all we are doing is ‘squeezing the balloon’ and causing people to shift from one drug of abuse to another. Only when we let the air out of that balloon by reducing the demand will we be successful.

We also need to address the factors that cause prescribers to over-prescribe opioid analgesics. There are several of these, including inadequate education about pain management in general and non-pharmacological pain management in particular, and about substance abuse; reimbursement models that reward prescribers for writing prescriptions but not for taking the time needed to understand and appropriately care for someone with pain; inadequate access to, and reimbursement for, non-pharmacological treatments for pain; and support for basic research to develop new, non-addictive tools to treat pain, as well as clinical research about how to better use the tools we already have. All of these things are, to some extent, good targets for policymakers.”

Dr. Kolodny: “I have a problem with the way you’re asking this question, too. The question accepts the opioid lobby’s framework. It implies that we have two distinct groups — pain patients who are supposedly helped by opioids and so-called ‘drug abusers’ who are harmed. The reality is that opioid addiction can develop in people who take opioids exactly as prescribed just as it can develop in recreational users. The majority of overdose deaths appear to occur in pain patients receiving legitimate prescriptions. We need cautious prescribing practices to protect medical and non-medical users.

There’s one law already on the books that if properly enforced would help bring our opioid addiction epidemic under control without impacting appropriate access to opioids. I’m referring to the Federal Food, Drug and Cosmetics Act. This law gives the FDA the authority to prohibit drug companies from promoting products for conditions where risks of a drug’s use are likely to outweigh benefits. If the FDA had been enforcing this law, drug companies never would have been permitted to promote long-term and high-dose opioids for common problems. We might not have an opioid crisis today had the FDA properly enforced this law going back to the late 1990s, when OxyContin was released. And if the FDA were to start enforcing this law now the CDC would have a much easier time convincing doctors of the need to prescribe more cautiously.”

Q: Who or what is/are to blame for the growing addiction to opioids and skyrocketing overdose rates?

Dr. Twillman: “I think there’s more than enough blame to go around. Society’s desire for a ‘magic pill’ that will fix whatever ails you produces too great a focus on medications and leads to inappropriate prescribing. Clinicians who are pressed to turn over their exam rooms every 15 minutes contribute because the only way they can keep up that pace when caring for someone with chronic pain is to just write another prescription. Insurance plans that pay for prescriptions and procedures but not for adequate physical therapy, psychotherapy, acupuncture, massage, chiropractic care, etc., drive both clinicians and people with pain toward treatments that may be less effective in treating chronic pain and more prone to causing a substance use disorder. Marketing practices by pharmaceutical manufacturers have reinforced the primacy of opioids as a treatment for all kinds of pain. Drug control efforts that only focus on half of the problem (i.e., supply) without addressing the other half (i.e., demand) are completely ineffective at reducing the rate of substance abuse. In light of all these factors, and others that may be in play, is it really any wonder that this has been a pretty intractable problem?”

Dr. Kolodny: “There’s lots of blame to go around but I believe the root of the problem was a brilliant marketing campaign launched 20 years ago by opioid manufacturers. The campaign misinformed the medical community. The risks of opioids, especially the risk of addiction, were downplayed and the benefits were exaggerated. Doctors were misled to believe that the compassionate way to treat just about any complaint of pain was with an opioid prescription. In response to this campaign, prescribing took off and led to parallel increases in rates of addiction and overdose deaths. Millions of dollars were spent misinforming prescribers and very little has been done to correct the record.”

Q: What’s the best way(s) to manage chronic pain?

Dr. Twillman: “Every person with pain is different and thus needs an individualized care plan. To properly care for someone with pain, it is necessary to understand the biological, psychological, social and spiritual factors that contribute to that person’s pain experience. This explains, to some extent, why two people with exactly the same injury can experience vastly different levels of pain intensity and functional impairment. Once the clinician determines each person’s unique combination of these factors, it is possible to craft a unique combination of treatments in order to achieve the best possible pain relief and functional improvement. Forming an effective, caring treatment relationship requires considerable effort and time on the part of both the clinician and the person with pain, but without that investment it is very difficult to achieve optimal outcomes. That sense of being in a caring relationship is also important and the connection between the person with pain and the clinician that it fosters can, in itself, be healing. When a caring therapeutic relationship is established, both parties can find alignment with respect to the goals of care and the means to achieve those goals.”

Dr. Kolodny: “There are many treatments for pain that are effective. They include non-opioid medications like non-steroidal anti-inflammatory drugs (i.e., Advil) and acetaminophen. These medicines also carry risks but they are sold over-the counter for a reason — they are safer. And according to the National Safety Council, when drugs like Advil are combined with Tylenol, they can be more effective than opioids, even for severe pain. There are also non-pharmacological approaches. The problem is that many of these treatments involve more effort and expense than simply giving out pills. As a society, we’ve grown accustomed to believe there’s a pill for every ill. This mindset has been encouraged by the pharmaceutical industry. In the short run, this also works out well for health insurance companies because a quick primary care visit and a prescription may cost less than more effective treatments and interdisciplinary care.” 

What do you think: Are laws controlling opioid painkillers hurting people in pain?

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