Last week, U.S. Drug Czar Gil Kerlikowske testified before the House Energy and Commerce Committee during a hearing on prescription drug overdose deaths. Kerlikowske called for a prescription drug monitoring system, more education about the dangers of opioid painkillers, and more restrictions on how they're distributed and prescribed. The committee also heard from several state attorneys general, addiction experts, officials from the Drug Enforcement Administration, and representatives from pharmaceutical companies, drug stores, and distributors and wholesalers of prescriptions drugs.
All of the witnesses began their testimony on the assumption that there is a prescription drug abuse epidemic in the U.S., and that access to controlled drugs, benzodiazepines and especially opioid painkillers, needs to be restricted, or at least monitored.
Noticeably absent from the hearing, however, was anyone living with chronic pain, or anyone even to speak on behalf of pain patients. Patients and their advocates say last week's hearing is typical of the lack of balance in the public debate over painkillers.
It's not hard to find such people. Since the first two installments of this series were published, HuffPost has heard from over 300 people who suffer from chronic pain and have at some point found relief from prescription painkillers, but have since been unable to find adequate treatment. We plan to track a set of those patients over the next year, documenting their frustration or progress in finding treatment.
One Indiana pain patient who wrote to HuffPost tells a typical story. Faced with debilitating pain from spinal stenosis, she was told by local doctors she was displaying the drug seeking signs of an addict, and they refused to treat her. "I have never used an illegal substance, and seldom have a glass of wine- I've never had a beer in my life," she writes. She was finally able to find a pain specialist, but in California. She makes the trip every three months for the high-dose opioid therapy she says makes her life bearable. But the cost of flying to the west coast ever few months is taking a toll on her finances. "I have asked for help finding a pain management doctor closer to Indiana," she writes. "I have searched online. I cannot find any one willing, or qualified to take me. I am a Christian and I do not believe in taking my own life, but I pray for an answer before I have no way to survive. I am not alone. There are so many pain patients whose lives are a living hell -- waiting and praying to die."
The issue of pain, particularly chronic pain, is endlessly complex, and fraught with years of contradictory policies, a lack of research, contradictions in the existing research, push and pull from government agencies, and -- particularly over the last few years -- contentious disagreement within the medical community over what's safe and what's effective. For people who suffer from chronic pain that can be debilitating, the resulting mixed messages can be terribly frustrating. They face difficulty finding doctors who are willing to treat them, doctors who are incentivized to be suspicious of them, and in some parts of the country, a paradoxical influx of "pill mills" run by unscrupulous doctors, where prescriptions for opioids flow freely, but without the sort of individualized care and monitoring chronic pain patients need.
Even as the DEA, the Office of National Drug Control Policy (which Kerlikowske oversees), and parts of the Centers for Disease Control have sounded alarms about overdose deaths and the need to restrict access to opioid painkillers, other organizations are simultaneously calling attention to the number of pain patients who go untreated. The second part of this series noted a 2011 report by the Institute of Medicine that called pain treatment a "moral imperative," and warned of the legal and regulatory barriers to effective pain treatment, particularly with opioids. Myra Christopher, who works on pain and palliative care at the Center for Practical Bioethics and served on the committee that published the Institute of Medicine report, says the mixed messages can even come from within the same government agencies.
"We work with the CDC's End of Life Care program, and they've been great about stressing the importance of pain management and palliative care. But I think there are many places [in government] where chronic pain and pain patients need to be considered, and they really aren't. There needs to be more dialog across centers and across agencies, and that isn't happening," says Christopher.
Part of the problem may lie in the fact that the government agency that controls the supply of opioid pain medication in the U.S., the DEA, is specifically charged with eradicating drug abuse. There's no countervailing charge in the DEA's mission to ensure that legitimate pain patients have access to the drugs that can give them relief. The incentive is to err on the side of control and restricted access.
It's the type of error that "Mike," a New York City artist who wrote to HuffPost, has been on the wrong end of too often. "I've suffered from severe refractory migraines my entire life, and am forced to take pain killers. It is insane the degree of time, money and effort I have to go through to get medicated for what is clearly a legitimate, refractory (unresponsive to typical treatments) disease." Mike writes that he's tried other treatments, but only opiod painkillers work. The problem, he says, is that "doctors are afraid to prescribe them, or they think I am an addict," even though he's been at the same dose for years. "It's insane and extremely depressing," he writes. "I live constantly in fear of either getting a totally debilitating headache or of running out of meds. I have had the headaches my entire life, and finally found a drug regimen that allows me to function -- to keep my job and get up and do everyday things -- yet I am treated like a criminal."
Russell Portenoy, who chairs the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, is a leading supporter of opioid treatment. He said there's a concerning lack of balance in the dire warnings about painkillers. "There are just as many deaths associated with the use of anti-depressants, or from liver failure associated with the use of acetaminophen, but you don't see the same sort of language about risks associated with those drugs. Opioids are just a medical therapy," he says. "They need to be carefully managed, but there's this age-old fear of them that seems to make them more urgent than other public health concerns."
Christopher says while there are references to patients concerns, but they're drowned out by warnings. "You might see a line, really a throwaway line, in some of the press releases about how these recommended new policies won't preclude or limit access to patients, but the reality is, they do exactly that."
Doctors are terrified of criminal or administrative investigations, which can end their medical careers, even if they're eventually cleared, Christopher says. "They feel besieged. And it's not necessarily even a fear of criminal charges. It's about getting investigated, about having the DEA come and say, 'We'd like to look through your files.' You then have to pay for a defense, and take time away from your practice to defend yourself." This, Christopher and other patient advocates say, is why it's so difficult for pain patients to find conscientious doctors to treat them.
Yet at the same time, the total number of prescriptions for opioid painkillers is soaring. Maia Szalavitz, a journalist who has covered the pain issue for 10 years, explained the contradiction. "Doctors and dentists are more than happy to prescribe more than enough of an opioid to treat the acute pain associated with an operation or dental procedure, because they don't want to be bothered by that call in the middle of the night when a patient has run out of painkillers," Szalavitz says. "But chronic pain patients require more care, and more drugs. So physicians are much more reluctant to treat them. If you take on more chronic pain patients, you're prescribing more opioids overall, and that's what raises the suspicions of investigators."
Divisions Among Doctors
To add to all of this confusion and contradictory information, there's also a growing division in the medical community over the effectiveness and safety of using opioids over long periods of time. There are patients who say long-term, high-dose opioid therapy has saved their lives. There are doctors who say they've seen and treated such patients.
But there are also doctors who are as equally skeptical. One of them is Andrew Kolodny, an addiction specialist who founded Physicians for Responsible Opioid Prescribing, an organization whose stated mission is "to promote cautious, safe and responsible opioid prescribing practices." Kolodny says there's no evidence to support the idea that long-term opioid use is effective for a significant population of patients. "The people advocating for this kind of treatment are advocating a treatment with substantial risk. And there's just no data showing that it's effective."
But there are patients who swear by it. One is "Danielle," a 55-year-old woman who had had chronic back pain since 1998. Since a surgery in 2003, she has lived with a steel plate and six screws in her neck. In an email to HuffPost, she explains that opoids have helped her to cope with the pain. But her doctor is now under investigation, and says he can no longer treat her. She fears she'll be unable to find someone else to treat her. "The pain is unbearable," she writes.
Christopher says the absence of data is due more to a lack of data. "The short-term data is good. We know a lot about the use of opioids up to 16 weeks. But there's a real paucity of data beyond that. We need more basic science. We have anecdotal evidence that long-term opioid treatment can be effective with some patients, but we need more qualitative data."
"The old line is that absence of evidence isn't evidence of absence," says Szalavitz. "We also don't have much data on the use of anti-depressants over long periods of time, or for many other prescription and over the counter drugs. That doesn't necessarily mean they don't work. The FDA only requires short-term testing, and most drugs we use long-term aren't tested long-term."
Portenoy agrees. "We need more long-term data, but we can't get long-term data without long-term treatment. Until then, you have to go with physician experience, with anecdotes, with testimonials. And I'm certain that there is a percentage of chronic pain patients for whom this therapy not only works, but it's the only therapy that works."
But Kolodny says the lack of data coupled with the chance of addiction and overdose among these patients isn't worth the risk. But on the risk of opioid addiction too, there's a sharp division of opinion. Opiod critics say accidental addiction among pain patients is common. Opioid supporters say that among patients who don't already have other addiction problems, it's extremely rare.
"There's no question in my mind that we are in the middle of an epidemic," Kolodny says. "This over promotion of opioids for treating chronic pain by the pharmaceutical companies and their representatives is causing the disease of addiction, and patients are dying." Kolodny's organization includes a video on its website of an interview with CDC Chairman Thomas Frieden and several other doctors who argue that addiction in pain patients isn't rare.
"The notion that chronic pain patients don't get addicted is just misinformation," Kolodny says. The CDC's Frieden said in a press conference earlier this year that doctors are now more responsible for addiction in America than drug dealers. And Kolodny's organization points to a 2011 study finding 35 percent of chronic pain patients on opioids "meet the criteria for addiction."
But Szalavitz points to other studies showing that less than 1 percent of pain patients with no prior history of drug abuse wind up addicted to opioids. When patients aren't screened, it's a little over three percent -- which means the vast, vast majority of pain patients never get addicted. "If you've made it out of your twenties without an addiction or alcoholism, there's very little chance you're going to get addicted to painkillers while under the care of a physician," Szalavitz says. "Eighty percent of Oxycontin addicts got the drug from someone other than a physician or had prior experience in rehab.
The video about risk of addiction among pain patients on the Physicians for Responsible Opioid Prescribing website also includes clips from Russel Portenoy. But Portenoy, who says he finds the message of Kolodny's group "troubling and concerning," says the clips of him were taken out of context, and posted without his consent. He doesn't agree with the video's message. "Patients treated by well-trained doctors who are carefully screened, monitored, and treated aren't going to get addicted."
The Public Policy Debate
If there's contention in the medical community about the risk and effectiveness of painkillers, the debate gets more heated still when it comes to what sort of public policy should govern how the drugs are used.
But first, there are at least a few areas where most voices in the discussion seem to agree. There's broad agreement that opioids are effective and mostly safe for the treatment of acute (temporary) pain, such as pain from a broken arm or after a surgery. There's also broad agreement that opioids should be used to treat pain in end of life care, or for terminal patients, where addiction is less of a concern. There is agreement that there are bad doctors running "pill mills" who are too loose with the prescription pad. And there's agreement that far too few doctors get effective training in pain management (but disagreement over what that training ought to be).
But that's about where the agreement ends. Patient advocates say the pill mills are the result of bad policies that have had a chilling effect that has scared good doctors out of pain management. They add that more laws aimed at curbing access to opoids will only worsen the problem. Portenoy, for example, points to a new law in Washington state requiring doctors to go through a number of detailed procedures before prescribing opioids to chronic pain patients. The result, as the Seattle Times reported last August, has been for doctors to stop treating those patients, and for clinics to turn them away.
Most government officials and doctors would like to see some sort of electronic database for prescription drugs. But here too, details matter. Doctors want the databases so they can check to see if a patient has sought prescriptions from other doctors -- an indication of the drug seeking behavior you see in addicts -- especially if they're going to be held liable, possibly criminally liable, for prescribing to such patients. But pain patients argue that as more and more doctors are reluctant to treat chronic pain, legitimate patients often have no choice but to see multiple doctors in search of one who will treat them, which can cause them to be wrongly identified as addicts.
Law enforcement agencies want access to databases to identify doctors who over-prescribe and pharmacists who fill too many painkiller prescriptions. Both patient advocates and doctors generally believe giving law enforcement access to the databases could lead to fishing expeditions by investigators, further dissuading physicians from taking on chronic pain patients.
Patient advocates also worry about privacy. In Washington state for example, the state database can be accessed not only by doctors, pharmacists, and local, state, and federal law enforcement, but also by the state's workers' compensation program, Medicaid, the Department of Corrections, the Department of Social and Health Services, prosecutors, and medical licensing boards.
In 2009, Christopher's organization, along with the Federation of State Medical Boards and the National Association of Attorneys General, published a series of policy recommendations, including one to separate medical negligence from criminal liability, balance publicity (including ending prosecutors' tendency to gin up publicity while prosecuting a doctor), ensure that law enforcement experts have access to pain specialists when investigating doctors, implement electronic databases (but with protections to prevent law enforcement from using them to fish for investigations), and educate doctors, patients and the public.
Portenoy says most changes need to come in the form of physician training. He says the dearth of pain specialists means more primary care physicians need training in chronic pain management. He says physicians also need a safe harbor within which they can prescribe without fear of investigation, and that the safe harbor should allow for innovation and outside the box treatment. Portenoy also frowns on drawing hard lines on maximum dosages or total prescriptions written, beyond which a doctor's treatment becomes criminal.
On the government side, nearly all the federal agencies who have weighed in on the issue advocate restricting access to painkillers, databases for monitoring patients and doctors, and a greater role for law enforcement and regulatory agencies to investigate doctors, pharmacies, wholesalers, and pharmaceutical companies.
Kolodny says he doesn't have any specific policy recommendations, and he wouldn't completely prohibit opiate therapy for chronic pain. Rather, he advocates primary prevention by changing attitudes and educating physicians about what he perceives to be the dangers of opioid treatment. "If someone has, say, chronic hip pain, I'd tell them to manage it with Tylenol," Kolodny says. "On really bad days, maybe they take a single Vicodin from a locked medicine cabinet." Kolodny also advocates for better diagnosis and treatment for those who are already addicted.
Even the general goals of public policy are in dispute. Christopher's organization stresses balance between two public health issues: the treatment of pain, and the problem of addiction. "These are both problems, but I think there's a rush to link the two, and there's no evidence of a causal link between them," she says.
Kolodny disagrees. "There's no question that the move toward treating chronic pain patients with opioids is leading to overdose and death. The opioid advocates will talk about balance, but this isn't about balance. This treatment is harming far more people than it's helping."
The more strident pain patient advocacy groups also eschew balance between treatment and addiction, because, they say, the two are separate issues, and shouldn't be compared. They stress that the treatment of pain is completely separate from control -- that the actions of addicts and drug dealers should have no impact on how doctors treat pain patients.
Szalavitz, herself a former heroin addict who now writes about the pain issue, has a unique perspective. "I often feel guilty about this. Because I had a problem, an addiction problem, and because of the existence of people like me, pain patients are now made to suffer."
CLARIFICATION: Russell Portenoy is paraphrased in this article to say he didn't consent to the use of a recorded interview with him in a video by Physicians for Responsible Opioid Prescribing (PROP). In an email Portenoy clarifies that he did sign a consent form allowing for any use of the video, but he did so under the impression that the video would be about finding balance in opioid treatment, not for the video that was eventually produced, which stresses the addiction potential of opioids. Andrew Kolodny of PROP insists that the portions of Portenoy's interview that were used for the video were not taken out of context.