After more than a decade of increasing opioid prescribing for chronic pain, the pendulum may be swinging the other way. A recent editorial in a major journal appears to reflect common misunderstandings and negative perspectives on the effectiveness and potential harms of opioids. So, it seems essential at this time to dispel the myths and shift the dialog back toward patient needs and benefits of opioids.
Writing in the September 17, 2011 edition of the Archives of Internal Medicine, Deborah Grady, MD, MPH, and colleagues from the University of California at San Francisco and Los Angeles, discuss “Opioids for Chronic Pain” [Grady et al. 2011]. However, a more apt title might have been, “Why Not to Use Opioids for Chronic Pain,” as they present negatively biased views about risks and harms of these medications. While we do not question that this editorial was well-intended, in the interest of fair balance there are numerous misrepresentations — expressing a false mythology surrounding opioid analgesics — that must be challenged.
The “myth-representations” expressed by these authors in their editorial are of some concern and importance for two reasons:
- It is a message going to the broader medical community in a major journal, with a potential for inspiring “opiophobia” that could negatively affect beliefs and opioid-prescribing practices, and
- the expressed biases and misinterpretations of research are not new and are typical of similar perspectives on the subject appearing in journals and being presented by speakers at medical conferences.
To begin their editorial, Grady and colleagues acknowledge that chronic pain affects 20% to 40% of adults [and the latest estimate is that 116 million adult Americans suffer chronic pain; see UPDATE here]. Furthermore, they note, 15% to 20% of office visits in the United States include an opioid prescription and 4 million of those are for a long-acting opioid. [In other data, the U.S. CDC (Centers for Disease Control and Prevention) estimates there are 10-12 million Americans on long-term opioid therapy.] The editorialists concede that this preponderance of opioid prescribing naturally evolved from an increasing recognition of pain and the need for its adequate treatment. However, they further state:
“This situation would be acceptable if the benefits of opioid treatment clearly outweighed the risks. Astonishingly, little is known regarding the long-term efficacy of opioid therapy for chronic pain. Of the 25 recommendations included in the Opioid Treatment Guidelines of the American Pain Society [APS] and the American Academy of Pain Medicine [AAPM], none is supported by high-quality evidence.”
We have previously criticized the APS/AAPM “Guideline for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain” [access document here] and its failings in proffering strong recommendations based on weak evidence [see e-Briefing PDF here]. However, the implication in the editorial is that benefits definitely do not outweigh risks, which is a remarkably absolutist assertion in the face of insufficient and/or deficient evidence.
It reflects what is called an argumentum ad ignoratum, or appeal to ignorance, by connoting that opioids incur inordinate risks and are ineffective long-term because they have not been proven otherwise, when, in fact, the high-quality research has not been done to establish the facts one way or the other. Another way of stating this is the old maxim, “the absence of evidence is not evidence of absence” [see Altman and Bland, 1995].
The authors also protest that most efficacy trials of opioids for chronic pain have been of small size, of short duration, have included select groups of patients, and have been placebo-controlled rather than comparisons with other active therapies. They further observe, “In general, these trials report that opioid therapy results in approximately a 30% reduction in pain scores. Effects on functional outcomes are more mixed and the benefits more modest.”
Again, the lack of high-quality evidence in this case does not confirm with certainty that opioids have no place in the long-term treatment of chronic pain. And, the assertion that opioids produce only a 30% reduction in pain is an overreaching generalization, as many trials of individual agents have demonstrated far better outcomes for select conditions in terms of both pain relief and functionality. Complaining that comparisons have only been made with placebo is again over-generalizing but, even so, randomized placebo-controlled trials are a high standard of evidence and there are no direct, head-to-head comparisons of a great many drugs used in everyday clinical practice. Why should opioids be held to a different standard?
As for the demonstrated long-term effectiveness and relative safety of opioids, there actually is evidence. As we discussed in an UPDATE [here], Forest Tennant, MD, has assembled an extensive array of documented cases in patients with chronic pain, ranging in age from 30 to 83 years, who have responded well to and thrived on opioid analgesic therapy for from 10 to 35 years. He observed relatively few complications of the therapy, and those were easily managed. The fact that more comprehensive, higher-quality, clinical studies of this nature have not been done — perhaps using extensive data-mining approaches that are often otherwise used to detect the more negative aspects of opioid therapy — may reflect an inherent bias against opioids among researchers and funding agencies.
The editorialists continue…
“…the harms associated with opioid therapy, especially high-dose therapy, are clear. Many patients require ever-increasing doses of opioids to attain the same pain relief. It is unclear whether this need for increased dosage is due to disease progression, development of opioid tolerance, or addiction. Nevertheless, many patients eventually take opioid dosages equivalent to more than 100 mg of morphine per day for many years.”
This argument ignores the basic pharmacology of opioids while proposing an arbitrary 100 mg/day of morphine or equivalent dose ceiling. Needing increasing amounts of analgesia is associated with harm by the authors; whereas, the development of opioid tolerance is a natural biological phenomenon, which may be further influenced by interacting comedications, individual metabolism, disease progression, and other factors. The authors further raise the specter of addiction, which rarely occurs de novo in patients taking prescribed opioids, is a diagnosable condition, and should be clearly detectable by appropriately trained practitioners [see discussion in e-Briefing, p 6, here].
Physiologically, there is no ceiling for opioid analgesic effects (with the exception of opioid agonist/antagonist agents, such as buprenorphine), and some patients with intractable severe pain may require multiple grams per day of morphine or equivalent dose (MED). The editorialists’ suggestion of a maximum safe threshold amount, 100 mg/day MED in their case, has become a widespread and pernicious myth (explained in the text further below).
Grady et al. further state…
“Because federal and state regulations require that these prescriptions be filled on a monthly basis, health care professionals and pharmacists spend an inordinate amount of time dealing with narcotic prescriptions. Also, many patients express chronic anxiety regarding their next refill and expend enormous effort to obtain their medications.”
The implication here is that “narcotic” [an unfortunately biased word choice, see UPDATE here] prescriptions are simply too much bother for busy healthcare providers, which is a rather disappointing perspective. And, an important reason that patients have “chronic anxiety” and obsess about a continued supply of their vital opioid medication might be due to those cavalier attitudes of some prescribers and pharmacies.
The editorialists go on to observe that opioids are associated with “significant risks of addiction, tolerance, opioid-induced abnormal pain sensitivity, constipation, nausea, somnolence, and immune suppression.” Of these, constipation is the only adverse effect that has been consistently demonstrated to occur with opioids, and it can be medically managed relatively easily. As noted above, addiction is a rare occurrence and tolerance is a natural, often beneficial phenomenon. For example, nausea and somnolence are usually transient and resolve as tolerance to properly dosed opioid medication develops. Immune suppressive effects of certain opioids have been demonstrated in vitro, at ultra-high doses, but clinical manifestations of this in humans needs further research.
“Opioid-induced abnormal pain sensitivity,” more commonly described in the pain literature as “opioid-induced hyperalgesia,” or OIH, has been demonstrated in animal models, but as a common and significant adverse effect of opioids in humans it remains a controversial and unresolved topic of ongoing investigation. Unfortunately, presumed OIH is sometimes used as an excuse to discontinue opioid analgesia when a patient requests more of the medication.
Grady and colleagues continue their case against opioids by citing typical facts relating to opioid involvement in substance misuse (“abuse”), overdose, and deaths. They note that prescription “painkillers” [another biased word choice] are the most commonly misused drugs, second only to marijuana, and have accounted for increasing admissions to substance abuse programs in the United States. This, indeed, is of great concern; however, the absolute rates of opioid misuse in the entire population are relatively miniscule compared to the large numbers of patients who compliantly take opioids daily as prescribed and do not misuse or become addicted to these medications [eg, see UPDATE here]. The authors additionally argue…
“Of most concern, opioids are associated with a substantial risk for overdose and death. In 2007, prescription opioid overdose was related to 11,499 deaths, a number greater than that of the combination of deaths from heroin and cocaine. Deaths from opioid overdose have risen steadily since 1990 in parallel with increasing prescription of these drugs.”
It is important to consider that, not only have there been increases in opioid prescribing during the timeframes noted above, but also concurrently increased prescribing of many psychotropic drugs (eg, for anxiety or depression, or as adjunctive pain therapy) along with soaring rates of alcohol and other substance misuse. Data regarding opioid-related overdoses and fatalities have been burdened by unclear forensic definitions of such occurrences and biased studies that have distorted incidence rates.
For example, in many reported cases, prescribed opioids have been present in a lethal cocktail containing other prescribed medications, alcohol, and illicit substances; yet, the incidents are recorded as opioid-related overdose or death, which skews the data toward opioids. In one report from the U.S. CDC, they noted that more than one drug was listed in 72.3% of death certificates of alleged opioid-related fatalities, including benzodiazepines (in 21%), antidepressants (32%), and/or illicit drugs (22%) [MMWR 2009].
The editorialists, themselves, concede that persons with depression [possibly receiving medications for this] and concurrent users of benzodiazepines experience increased risks of opioid overdose. Furthermore, they claim…
“Risk of overdose and death increases with higher doses of opioids. In 1 study, patients taking more than 100 mg per day of morphine-equivalent opioids displayed a 9-fold increased risk of overdose compared with that among patients taking less than 20 mg; the risk was approximately 2% per year among patients using high-dose opioids.”
Their referenced source for this statement is a study by Dunn and colleagues, published in 2010, and this misleading report [discussed in a Pain-Topics UPDATE here] has served as the basis for the 100 mg MED safety threshold myth adopted without critical assessment by many other authors and conference speakers. In this retrospective data-mining research, spanning 9 years and including 9,940 patients receiving long-term opioid analgesics for chronic noncancer pain, there were only 51 opioid-related overdoses (which included 6 deaths), or a 0.057% yearly incidence rate. Those receiving ≥100 mg/d MED appeared to have a greater overdose risk but they comprised only 22% of all overdose cases; so, the greatest frequency of events in this population involved doses below this level.
Further complicating the Dunn et al. data, roughly three-quarters of patients (74.4%) had been prescribed sedative hypnotics, including benzodiazepines. Eight cases of overdose were due to accidental excess ingestion of opioids, 6 involved suicide attempts, and 11 involved drug misuse or illicit opioids. So attributions of cause, and particularly implications of higher-dose Rx-opioids as most culpable, are highly questionable — yet, this myth has endured.
Some additional evidence, overlooked by Grady et al., should be mentioned…
- A recently-reported study — published in JAMA, April 6, 2011, by Bohnert et al. [discussed in an UPDATE here] — compared retrospectively culled records of 154,684 patients (32% of whom were prescribed long-term opioids for chronic noncancer pain during a 5-year period) compared with 750 cases of unintentional Rx-opioid overdose deaths in the population (a total fatality rate calculated by the researchers as 0.04%). The overdose rate was greater for opioid doses ≥100 mg/d MED as compared with lower doses (1 to <20 mg/d); however, most deaths (43.5%) were inexplicably in persons listed as receiving 0 (zero) mg/d and/or patients with substance-use disorders. As with the Dunn et al. study, there were many potentially confounding factors unaccounted for, including the presence of co-medications or illicit drugs, polysubstance misuse, and co-occurring medical conditions.
- Another recently-published report, by Gomes et al. [2011] in Canada, retrospectively examined more than 600,000 persons prescribed opioid analgesics for chronic noncancer pain during a 10 year period and discovered 593 associated fatalities, or an annualized death rate of only 0.01%. They found a greater risk with >200 mg/d MED than in persons taking <20 mg/d MED; however, among the many confounding factors in this research that biased outcomes, benzodiazepines also were present in 85% of all decedents taking opioids. [See UPDATE here.]
- It is interesting to note that the APS/AAPM Opioid Guidelines (noted above) state: “By panel consensus, a reasonable definition for high dose opioid therapy is >200 mg daily of oral morphine (or equivalent), based on maximum opioid doses studied in randomized trials and average opioid doses observed in observational studies. Some studies suggest that hyperalgesia, neuroendocrinologic dysfunction, and possibly immunosuppression may be more likely at higher opioid doses, though more evidence is needed to define these risks, their relationship to dose, and their relationship to clinical outcomes [emphasis added].”
It is important to consider that the >200 mg/d MED was a “best guess” of the panel based on very limited evidence and that the purported adverse effects at this “high dose,” as well as their clinical significance, are admittedly still undetermined.
- Of further interest, new opioid prescribing rules soon going into effect in Washington state adopted a 120 mg/d MED benchmark ceiling of opioid prescribing for chronic noncancer pain, and higher doses would require special considerations or actions by the healthcare providers prior to continuing therapy [see UPDATE here]. Other than a reference [in PDF document here] to the poor-quality study by Dunn et al. (noted above and specifying 100 mg/d MED), the evidence base in support of this 120 mg/d MED number is unclear and the specific number seems to have been set rather arbitrarily. Curiously, state authorities also concede, “There is no clearly defined ‘safe’ opioid dose. The guideline does not say that a dose above 120 mg/day of morphine equivalents is necessarily unsafe, nor that doses below this are guaranteed to be safe” [emphasis added, also see Washington state guideline document PDF here].
It seems intuitively pragmatic that as doses of drugs like opioids are increased there may be correspondingly greater risks of overdose and drug-related death. However, the research evidence to date suggests that the picture is much more complex and doses ≥100 mg/d MED, as suggested in the Grady et al. editorial, are probably only a secondary factor at most. And, as Bohnert et al. conclude in their study, the estimated overall risk of opioid overdose among individuals properly treated with opioids at any dose is quite small and opioid-related overdose deaths are an important but rare outcome.
In their editorial, Grady and colleagues assert, “Compared with shorter-acting preparations, long-acting opioids such as sustained-release morphine, sustained-release oxycodone, and methadone also increase risk of overdose.” This, too, seems commonsensical; however, in the study by Dunn et al. that the authors reference, fewer than 1 in 10 (9.6%) of all subjects had been prescribed long-acting opioids and there was no indication that these formulations played a greater role in overdose incidents than shorter-acting agents.
The authors comment on attractive features of methadone for chronic pain, but that it is “more dangerous than other drugs because it has complicated and unpredictable pharmacokinetics and pharmacodynamics and is associated with corrected QT-interval prolongation and cardiac arrhythmias.” Exaggerations of methadone’s alleged cardiotoxicity have gained much traction in the pain management and addiction treatment communities, but this myth is largely based on very limited data, along with biased and questionable interpretations of poor-quality research evidence [discussed in prior UPDATES here and here].
What actions do Grady and colleagues recommend in their editorial?
First, they suggest that the trend to prescribe opioids for patients with chronic pain should be reversed. Healthcare providers should first try to treat the underlying condition using nondrug modalities such as “physical therapy, cognitive behavioral therapy, pain management techniques, and appropriate assistive devices.” While this seems reasonable, many cases of chronic noncancer pain do not respond to such therapies and many patients exhibit no readily diagnosed underlying etiology or pathology. Although nondrug therapies can be important, research evidence for their possible effectiveness in chronic pain is still emerging.
The editorialists further recommend, “First-line drug therapy for chronic pain should include aspirin, acetaminophen, nonsteroidal anti-inflammatory drugs, and appropriate corticosteroid injections.” However, this completely overlooks the fact that these agents have toxicities and risks that in many patients are greater than those of even the strongest opioid analgesics [discussed in an UPDATEs series here].
Grady and colleagues go on to state…
“Health care professionals should evaluate pain and functional status at each visit. Patients who had no improvement in pain or function should not receive higher doses of opioids, and those taking dosages as high as 100 mg of morphine or an equivalent drug per day should not have their dose increased further.”
The authors again invoke the mythical 100 mg/d MED ceiling, without considering that a reason some patients may not realize improvements in pain or function is due to insufficient analgesia in the first place. Instead, they recommend that healthcare professionals should consider tapering or stopping opioids. Would practitioners similarly limit or discontinue insulin, rather than increase the dose, in patients who fail to achieve an arbitrary level of glucose control?
Another option, rather than increasing the opioid dose, the editorialists say, is referral to a pain specialist with a focus on treatments such as nerve blocks, corticosteroid injections, and behavioral therapy. However, there is probably even less good research evidence to support the long-term benefits of these interventional or cognitive therapies than there is for ongoing opioid therapy, at any dose. Thus, it seems clear by this point that Grady and colleagues prefer any option, no matter how questionable or risky, rather than opioids.
Finally, to synopsize their concluding statements…
“Many physicians will tell you they would be happy to stop prescribing opioids if a better option existed for treating chronic pain. ...[but] the lack of alternatives does not justify treatment with agents for which the risks outweigh the benefits. However painful it is to explain to patients who are experiencing chronic pain that we do not have effective and safe treatments for their pain, we should be willing to do so when appropriate. . . . . Health care professionals need to feel empowered to say no to the unnecessary, often risky, ever-increasing use of opioids without worrying that their judgment could be challenged. . . . . …we should not continue to prescribe high-dose opioids with little evidence of long-term benefit and clear evidence of substantial harm.”
These assertions from the authors, encapsulating the overall bias of this editorial, leave both practitioners and their patients with pain in a predicament. In our opinion, evidence of “substantial harm” from opioids, at any dose when properly prescribed for chronic noncancer pain, is far from clear. What does seem clear is that, just as their physicians might feel about prescribing opioids, almost all patients would happily forego opioids and accept alternative therapies for their pain — IF those alternatives were as effective as opioids.
Many other discussions of opioid harms and recommended solutions, coming from many directions, have echoed the perspectives in this editorial by Grady et al. Often, the stated objectives are something like, “Reduce abuse and overdose of prescription opioids while ensuring patients with pain are safely and effectively treated and have access to the drugs that they need.” While this seems noble and appropriate, the statement also might reflect a myth of beneficence: that is, it appears to have the best interests of patients in mind while, at the same time, encouraging actions or endorsing rules/regulations that are questionable in terms of their actual benefit to patients.
Meanwhile, healthcare providers have legitimate concerns about new rules and regulatory-agency scrutiny of their opioid prescribing practices, and of being duped by persons seeking opioids for dishonest and/or unlawful purposes. A certain amount of “opiophobia” on the parts of practitioners is understandable; especially, considering the lack of a strong, extensive base of high-quality research evidence and validated opioid-prescribing guidelines. At the same time, it is important to understand that decisions regarding opioid analgesics are being increasingly driven by demagoguery, and fear, and the myth-representations all too often found in communications like the editorial critiqued above.
Our own bias is that it is time to shift the dialog regarding opioid analgesics. While these medications may not be curative of a chronic pain condition, they can be a means to an end in providing essential relief from pain so that a patient might pursue additional therapeutic modalities to help promote enduring functionality and facilitate a better quality of life — albeit, a life that may not always be completely pain free. For many patients, opioids are a temporary measure — at whatever dose and period of time that are necessary — but, for some, these drugs may be a vital and relatively safe lifelong therapy for maintaining a more normal, comfortable existence; much like insulin, antihypertensives, antidepressants, or other medications are necessary in some patients. Rarely, if ever, would patients choose opioids (or any medication) over nonpharmacologic approaches, if the latter were readily accessible, affordable, and could provide comparable, lasting relief from pain and suffering.
We agree with others* that the greatest problem facing healthcare providers and society today is not too much pain medication or its misuse by a small minority of individuals; rather, the problem is too little pain relief for the millions of patients in need. Readers are invited to add their own opinions in comments below.
*Thank you to Lynn Webster, MD, for inspiring this thought.
DISCLOSURE: Pain Treatment Topics is currently supported by medical education grants from Purdue Pharma L.P. and Endo Pharmaceuticals, manufacturers of opioid analgesics. However, these organizations had absolutely no role in the inception, development, review, or approval of this UPDATE. The opinions expressed are those of the author.
REFERENCES (not otherwise linked within the text):
> Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311(7003):485 [PDF here].
> Gomes T, Mamdani MM, Dhalla IA, et al. Opioid Dose and Drug-Related Mortality in Patients With Nonmalignant Pain. Arch Intern Med. 2011;171(7):686-691 [abstract here].
> Grady D, Berkowitz S, Katz MH. Opioids for Chronic Pain. Arch Intern Med. 2011;171:1426-1427 [access here].
> MMWR [2009;58:1171-1175]. Reported in: Overdose death involving prescription opioids among Medicaid enrollees — Washington, 2004-2007. JAMA. 2010;303(1);21-22.
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28 comments:
Your term “Myth of Beneficence” says a lot. I was at the PAINWeek Conference recently and was astounded by the duplicity of so many of the presentations. Speakers would start out saying how essential and good opioids are for patients with chronic pain and then go on to incite fears of abuse, addiction, overdose, death, regulatory agency crackdowns, FDA REMS, and on and on. The underlying tone was that most patients are dangerous drug seekers and prescribers need to always beware of the bad guys. The conversation has become awfully lopsided and compassion for those patients who are truly suffering seems lost along the way. It’s tragic and frustrating. Thanks for your efforts above; maybe, some people will take notice.
I was distressed by the paragraph you quoted which boiled down to "Tell chronic pain patients there's nothing medical we can do for them." The idea that chronic pain patients should just shut up and suffer because opiates are baaaaaaaad is cruel and literally unfeeling.
" Also, many patients express chronic anxiety regarding their next refill and expend enormous effort to obtain their medications.”"
And you know why I have chronic anxiety? Because the system is set up to prevent my receiving this medication. Because pharmacies often don't stock it. Because I can't fill the medication in advance, so if I don't refill precisely on the date the refill is due, I wind up losing a day's analgesia with no chance of catch-up. The system could have been designed to make me anxious.
Doctors have prescribed habituating drugs for me without ever warning (Paxil, Remeron), but that's okay because they aren't the dreaded opiates. Any other drug category can cause physical habituation, and doctors' response is to plan to manage the withdrawal with careful dosage. But opiate patients' physical habituation is treated as a moral failing.
Sorry, sorry, preaching to the choir.
Perspective , nothing is perfect , so chronic pain will never be solved. Gravity , and old age is a part of our reality. Opioids is not the real problem.
There are far worse medications prescribed that cause awful problems than opioids. Why not put this whole discussion into perspective , it can be done.
So what's wrong with a 30% decrease in pain?
That last quote was one of the most depressing things on pain management I have ever read, because it is basically the thing I fear hearing most: we know this thing helps your pain, but you might get addicted, so you can't have it. Never mind that we can give it to you in a small enough amount to prevent addiction. Never mind that there are no alternatives. Never mind that you have taken it before and shown no tendency toward addiction other than kind of liking not being in pain. You can't have it.
Thanks for this Stew. These AAPS AAPM members are not scientists at all but charlatans. They are in the game to make money and pretend to treating pain. Opioids are safe and effective. To say otherwise is to defy common sense as well as the data. Can you imagine a doctor telling a person with diabetes that they can't have insulin because some tiny subset of people who take insulin die every year? These people are an embarrassment to the scientific method as well as to the ethics that are thought to govern the practice of medicine. They don't want to treat pain appropriately because they will be victimized by law enforcement, the hospital systems, the medical boards, opportunistic lawyers, insurance companies, family members, and the list goes on and on. Drug prohibition has wrought this insanity and nothing but ending it will stop the genocide.
Siobhan Reynolds
Recovering political activist
This has got to be driven by the pharmaceutical companies who make more money on drugs other than narcotics.
Disgusting. Perhaps they could become more enlightened by including actual pain patients on narcotics on their research team.
I can see more violent suicides and increased illegal drug sales from such stupidity. People who take their lives with drugs are over the top in despair and pain. Perhaps now they will have to purchase a gun. As though drug limitations will stop those who cannot tolerate life any longer.
Disgusting - how can an "article" be taken seriously when it is written by people Parading around as Doctors who are not Doctors (but instead "yes men" who failed interpreting data 101!).
Doctors care about their patients. Doctors treat their patients. Doctors despite the War on (Good) Doctors, actually treat chronic pain, properly, with opiates as they are safe, effective, and not so costly only the rich can afford them!
Any intelligent person KNOWS this (failed) war on drugs is not only dragging down our Country, our economy, our Freedoms, it's destroying the fabric of OUR Country - it's time the People demand that it is time to end it and all that disagree need to be shown the door.
Insanity is doing the same thing and expecting a different outcome, and more failure on top of decades of failure is continued insanity!
Vote AGAINST any Candidate who supports continuation of this failed "War" as it is a War on us, the US Citizens!
Why should those of us who use our narcotics as directed be punished because a few people abuse or sell their medications? That's like sending an innocent person to jail because one of her neighbors is a criminal. The illogic in this presentation is astounding.
The rate of addiction among chronic pain patients using narcotics is between 0.7% and 2.6% (http://www.ncbi.nlm.nih.gov/pubmed/20091598?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1 AND http://updates.pain-topics.org/2011/01/study-finds-low-risk-of-rx-opioid-use.html). Even more recent research concludes that using THC (cannabis sativa) is a useful pain reliever with very minimal side effects or addiction (http://www.webmd.com/pain-management/news/20100830/marijuana-relieves-chronic-pain-research-show?ecd=wnl_cbp_041411).
When will our medical and governmental communities have an open mind about treating intractable chronic pain? When will physicians become more motivated about the Hippocratic Oath than FDA scrutiny?
Unfounded fears of abuse, addiction, misuse and suicide should not motivate physicians or governmental organizations, particularly when the evidence is so flimsy and weak. Tens of millions of us have chronic severe pain. With appropriate narcotics, we can function as productive citizens. Without those powerful narcotics, we would decide not to live. Yes, the unending, severe pain can be that bad. When you make those medications difficult to obtain, you are murdering innocent people. I do not say this lightly or in jest. In know that I would decide not live without my medications. And, based upon hundreds of message board conversations with chronic pain patients, the vast majority would prefer death to life without their narcotics. Virtually none of these people abuse or sell their Rx. So, please think before acting, FDA. Don't throw out the baby with the bath water.
That much of the focus on the use of opiates in pain treatment is agenda-driven seems obvious. If not, then why is there such an obsessive focus on deaths and injuries in this one area of medicine to the exclusion of all else? Everyone who profits from the opiate drug trade has an agenda of making these drugs seem more dangerous than they really are, even the pharmaceutical companies that make them. If opiates are reasonably safe, what rationale is there for giving drug companies exclusive rights to produce them, or doctors a monopoly on prescribing them? Why shouldn't people with pain--or addicts for that matter- be free to use these drugs at will unless they are baaad, baaad, baaad.
Without government controls and restrictions on opiates, they would be cheap as dirt to manufacture and relatively worthless as a commodity compared to the gold mine they are in both the legal and illegal drug markets. Many patients with pain, upon achieving acceptable pain relief with opiates, might opt out of the more useless, expensive and invasive therapies often forced on them as a condition of receiving opiate therapy, or to which they are forced to turn due to lack of access to alternatives. That means a lot of broken rice bowls in the medical business.
Even if we assume no hidden agenda, we cannot accept studies of opiates such as those of the CDC which are based on coroners reports which do not accurately distinguish deaths caused by opiates from other potentially lethal drugs the deceased may have been using because they cannot. The science to do so isn't there, so why isn't there an acknowledgment of this whenever we see these studies?
http://www.time.com/time/health/article/0,8599,1996831,00.html?xid=rss-topstories
"Unfortunately, the mechanics of that determination are poorly understood — sometimes even by the toxicologists, pathologists and medical examiners who make the call. Circumstances of death surrounding drug use are also often difficult to untangle: In the Schneider case, virtually all the patients who died were found to have multiple drugs in their bloodstream, often including illegal drugs; in addition, many of the patients were known sufferers of chronic pain with chronic, life-threatening diseases such as heart disease and high blood pressure — conditions that can cause death on their own, without drugs.
Much of what scientists do know about drug-related death comes from the 25 years of research by Dr. Steven Karch, a cardiac pathologist based in Berkeley, Calif., who has written two widely respected texts on the topic. On June 7, he testified for the defense in the Wichita case, stating that in most instances of drug overdose, the currently available medical technology cannot accurately determine whether or which drugs caused death."
This is also of interest:
http://www.slate.com/id/2194716/
"The state's medical examiners were asked to distinguish between the drugs being the 'cause' of death or merely 'present' in the body at the time of death," the study states. Because medical examiners often attribute cause of death to multiple drugs, a single death can result in two or three drugs earning "credit" for causing the death. The report provides this disclaimer about such double- and triple-counting: "Many of the deaths were found to have several drugs contributing to the death, thus the count of specific drugs listed is greater than the number of cases."
In other words, a single death can often account for multiple instances of a particular drug being given credit for that death, just so long as it is present, and thus statistics based on such reports are likely to be inflated.
There are far more potent, addictive drugs being dosed out dramatically every day. Why are chronic pain patients being targeted? I believe to withhold narcotic pain relief for some will be an end. I have read and am part of a large group of pain sufferers and it is discouraging each day to read from people crying out in pain, despair and no hope for a future. I think the risks of increased suicide will be a wake up call for the "system". I hope it happens before too many lives are lost to a condition that could be managed with narcotics.
Suffering In MA
Its kinda funny this band of opiate biased Doctors (i say doctors not because they are respected people of medicine but because they all stayed and got the fancy diploma) do they not read the paper's not even six months ago Washington state and Oregon was having fits over the new formulation of Oxcycontin and that there normal junkies where now on slabs in the morgue because they turned to Heroin or Methadone and did not know how much to use as compared to there normal "oxcy" product and they were all dropping dead of overdose. it's doctors like the ones that wrote this paper that are fueling societies and real Doctors confusions over the Medical, Moral, Legal, Ethical controversy that exists today who can keep up?? Mostly the Non Cancer Chronic Pain patients are the ones that stay up late reading this stuff and have filling cabinets filled with printouts of these hair brained half witted publications so that they can defend themselves from these kinds of doctors who are killing people, i know people who drew there line in the sand and could not live with there pain and could not get a Doctor to prescibe the medication they needed because they moved from NY to Texas and the Doctors in texas did not want to continue to prescribe her Fentanyl patches so she ended up after six months and 20 Doctors saying no killing herself you ask well why did she move Economic she was offered a job in Texas whereas she was unemployed in NY. And my Doctor worked the Pain Pyramid with me,we used everything alone in combination and with other modalities until i had no choice but opiates and i went on them and was stable for two years and then she got a promotion and the doctor that took over her practice immediately had me sign a contract which i had never done before that was 1st appointment, 2nd appointment was Irregardless of the notes the doctor left on my case and despite her talking to him for about 3 hours about just my case, he declared me a liar and that i fooled my previous doctor of 15 years into giving me opiates for the last 3 years and he was cutting me off for my own good, he said i would thank him for it later . Then i tried all my other doctors and they all laughed at me and said no way,so i got all my records from all of my Doctors and went to the University Hospital in the city and the pain management Doctor read thru my records and my EMG's MRI's CAT's and was kind of apologetic that i had to drive all the way to see her to get medication that a blind man would be able to see that i clearly needed and started me gradually back on my med's, and my Personal Care Aide who was not with me back then wonders why i have so much love and respect for this Doctor and with her She refills my script monthly to the Pharmacy who always has my prescription in stock because its a nationwide pain pharmacy thats all they do and like clock work my medication comes on the same day every month Via U.P.S so theres no surprise and nobody at the local pharmacy gawking at you or saying we don't stock that because if we did we would be robbed so i am grateful to the university the Doctor i have and the Pharmacy program with the patient being the #1 reason everyone is there
Thank you, for the comments above (albeit, some are a bit rambling). We were hoping that healthcare providers might chime in with their reactions -- whether for or against our views of the Archives of Internal Medicine editorial.
We know that yesterday, after the UPDATE was first announced, viewings of it soared over the top; and more than 75% of our typical audience is healthcare providers. So, it is curious that they would remain so silent. Where are all of you?
A minor point in all of this (and I completely support your responses) is the inaccuracy contained in the following statement: “Because federal and state regulations require that these prescriptions be filled on a monthly basis..." To my knowledge, with the exception of a recent change in Florida law, having medications filled on a monthly basis is not a requirement of federal and state regulations. This is a phenomenon controlled instead by insurance companies, partly so they can avoid paying for, for instance, 3 months' supply of medications when only a week or two may be use, and partly so they can collect a copayment every month. Any untoward effect of this policy should be laid at the feet of the insurers, not federal and state regulators and legislators.
Thank you, Dr. Twillman, as always, for your input (immediately above). I believe the editorial authors were referring specifically to strong or long-acting opioid medications that cannot be ordered for more than a 30-day supply in a single prescription. -- SBL
Thank you for taking this article to task and debunking the proliferation of myths about opioids that continues to grow like a cancer.
As a Nurse Consultant for pain and palliative care I would like some of these authors to sit for a day with some patients with unrelieved or undertreated pain. Sit with them and witness the devastation that unrelieved pain has on their life and their dignity as a human being. Sit and listen to them tell of the abuse they endure each month as they go and submit to drug testing, rolling eye syndrome of the receptionists, the questioning and derogatory attitude of their healthcare provider, the admonition of their pharmacist that "you know these are highly addictive drugs and you could die"
Most sit and wish they could die rather than live in the pain they endure daily. Why should anyone have to wish for death to escape the pain.
We have within our tool box many treatments for pain of various causes. None cures the pain, but many will decrease the pain to a manageable level. None of my patients demand 100% relief but are glad when they can get 50% or more. some are glad for the 30% relief. What they really are grateful for is the dignity and respect given them during our visits.
Opioids are not inherently bad. They have good benefits and side effects just like any other drug/medication out there. When prescribed correctly and used correctly they are very effective and safe. BUT Opioids are just ONE of many useful tools in the tool box...but it is the most used...why, because the other tools are not always universally available; cost too much; are not covered by insurance. let's change the paradigm...and ask what should be in our tool box? Compassion and Respect along with therapeutic listening are tools that go a long way in reducing the pain and anxiety levels in many persons with pain. If we all practiced more Compassion, respect and acted justly toward all patients in pain we would get father ahead on this issue.
Thank you VERY MUCH for putting up this important "Myth-Buster" piece. It can be very discouraging too - especially to those of us whose health has been restored by the use of opioids in our pain treatment. Thank you again.
I was being prescribed opiods on a monthly basis for years by my PCP for chronic pain. There came a time when I reached a threshold of tolerance and ultimately needed more of the narcotic medication. I was sent off to a Pain Clinic instead and was treated to a myriad of spinal injections and radio frequency lesioning. This was done not with the intention of increasing my narcotic medication, but instead to lower the dose. To make a long story short, being unable to get properly medicated, I had to go to a Methadone Clinic and tell them I was a "drug addict" in order to get the proper medication to live a normal life. How do you fix a system that does this to people??? I wish every day that the people who make the laws could wake up with with my pain, even if only for a couple of hours. I think it would open their eyes for sure! I only hope that someday, maybe not in my lifetime, that opiates would not be looked upon so negatively and that chronic pain patients will be treated with dignity and respect!
Thank you, for the comments (immediately above). It is unfortunate, but many so-called Pain Clinics these days should have warning signs saying “Procedures Done; No Medications.” On this same subject, readers should also see our more recent UPDATE, "What’s Gone Wrong with Pain Management?" [here].
Thank you for this much needed article. I am a person with pain and a pain care advocate. I, too, was at PAINWeek and have the same comment: not only were opioid medicines painted in negative terms, these terms were supported by a slightly hidden paternalism that is also a part of these bogus research articles that spawn restrictions on the very medicines that have saved my life, and the lives of countless others. I think it would be beneficial to this discussion if the people who support this kind of research and this kind of blatant misinformation should be asked to step into the light of day. I, like a respondent above, am also anxious about my medicine. I have to go in every 30 days to get my prescription, and anything can interfere with the filling of these prescriptions: my doctor may be on vacation; he may fail to write in the dose; the pharmacy may be out of my medicine; the insurance company may refuse to cover the new prescription if I come to early to have it refilled, for example because of travel. This makes me anxious because I go into withdrawal within 24 hours of not taking my medicine, a powerful reason to be anxious about the prescribing of this medicine. Why on earth should I, and millions like me, be subjected to this?
Thank you for this great article. I'm a chronic pain patient who does get incredibly anxious because my meds are the one thing that allow me to be not only more functional but more comfortable. All the talk of late on the mainstream health channels is disparaging of chronic pain patients who need their meds just to have some semblance of a comfortable life.My doctor just moved and I am very anxious about having to find a new provider in this environment. I aleady have to make a trip out of state because WA ridiculous guidelines don't work for me. Where's the compassion?
It is so sad that an administrative group of Medical Directors (AMDG) can suggest guidelines on administrating opoids labeling it Best Practices and stating it is just guidelines and the medications dosing instructions are different, are taken as law, and made law in Washinton State and others.
Then this information is sent like wildfire and used at Seminars, posted everywhere as law, and new Doctors open their practices using this criteria as if Robots without regard to patients needs.
Also is forgotten is Federal Policy, The American Pain Act, Pain Patients Bill of Rights and other considerations .
Why this is so ironic is that Oregon allows for patients to have double doses of barbiturates to kill themselves.
Is there something wrong in our society today ?There needs to be a class action lawsuit in Washington by patients and not pain doctors so that the patients effected have no financial gain but gain to be a productive person in society and they cannot without pain relief.
I for one, am not a drug seeker but a patient with a diagnosed problem that needs medication.
If I was a diabetic needing insulin and high amount to make me functional, there would be no problem
It is time to be sensible and stand up for our rights.
It is time for Washington State Pain Patients do a grass roots petition and get great lawyers and start a class action suit of discrimination as other patients do not have their medications legally monitored and doses
allowed are lower that the manufactures recommendations.
Washington, get your lawyers. BJ
I live in WA state and am already in the process of having my pain medicine dose tapered off. No matter that I have been successfully been taking opiates for years with no drug-seeking behavior. You say get a lawyer for a class-action suit? I am on Social Security for severe, treatment-resistant, clinical depression. Chronic pain and depression are a lethal combination. I have been severely anxious, depressed, and angry at this unecessary law that is going to halve my already inadequate pain meds. I keep hoping that a group of doctors will stand up for those of us that live in poverty and rely on pain meds (as well as therapy, exercise, and meditation) to help us get through life with a modicum of dignity. Someone please help us! Thank You, Dawn Martin
Although not mentioned in the above article's witless & poten-tially harmful(to the point of malpractice)list of "appropriate" starting pharmaceutical protocols for chronic pain, there is another scary and potentially lethal prescribing practice being either "sold" to duped MD's or being grasped at as the much safer and time tested (2,000+ years)opioid treatment route becomes riskier for prescribers(and NOT because of the lame issues brought up in the article, but for fear of governmental agency reprisal).
What I'm referring to are powerful neurological drugs, originally designed to treat epilepsy, being prescribed-often off label-by non-neurologists as a first line treatment for chronic pain. Their brand names are Neurontin, Topamax, Lyrica, and others. They certainly can be expensive and they certainly have a long list of side effects. I personally was prescribed Lyrica, at the very lowest of starting doses, for less than a month. My body swelled horribly. It took two years before I could be weaned off of diuretics. Even worse, it caused serious proprioception issues (proprioception is the brain's sense of your body in space) that has continued unabated to this day. All this from a drug I took less than a month.
There is tremendous pressure for a chronic pain patient to accept trials of opiate alternatives--drugs and other expensive interventional treatments, because if you refuse for any reason you run the risk of being suspected of seeking only opiates (even if they are TRULY the only thing that has helped after years of documented trial and error).
Saddest of all is that I lost a very dear, long-time RSD internet support group friend in January of this year (2012) to a trial of Neurontin. I don't know why she was trying Neurontin, she had already been on opiate therapy with some success for many years. I do know that it grieved her deeply not to "be there" more for her husband of many years, a dock worker who had chronic pain himself. She wanted to at least have dinner on the table, the house picked up, and the dogs fed when he came home from work, and to be more of a companion to him. Perhaps it drove her to try this "one more thing." I don't know....but I'm so sad. I never met her in person but I loved her. She was brave and funny and sweet. But to most of the world, even the medical community, she was a throw-away. Probably lazy. Probably a pill seeker. Not easy to treat. Certainly not worth standing up against the DEA and saying "I don't care how many people get away with getting high on pain pills, because next decade it will be something else that is the headlining drug of choice. Her human right not to live in torture trumps the bad choices of others, PERIOD. If you as a government agency truly care about the deaths of addicts, then provide therapy for them. But they are two separate problems--severe, ongoing pain requiring opiate therapy; AND addiction or drug abuse. Any solution mixing them together will only torture the pain patient without making any true dent in the behavior of the addict. Are you listening as well, Washington State, and all the wanna-be's lined up behind you? Because my friend had more courage and compassion in her little finger than all you bureaucrats AND all the lobbyists who should be rushing to the aid of all of us like her, have in your whole ignorant, alternate agenda seeking bodies.
Death rate from opioid overdose in general population is about 0.00004. Death rate among those receiving epidural steroids is now 0.00003 from Apergillosis Meningitis caused by tainted DepoMedrol. But this tragic event requires a PHYSICIAN as vector for transmission, and the only ones at risk are people disabled by CHRONIC pain.
Does anyone on this thread know how the lawsuit brought against Washington State by PRN turned out? I am getting lots of Internet hits on the suit from 2007, but see anything that addresses the outcome of the case.
This effort to limit opioid availability has created a massive unmet demand for pain relief in a population that will pay whatever they have to for it. It's a nearly perfect inelastic market.
I think you can make a good circumstantial case that the health care industry (in WA state at least) fully supports the opioid regulations and took active or passive measures to ensure that the guidelines were adopted.
My HMO, Group Health Cooperative, implemented internal dosage guidelines/processes that are significantly more stringent than that required by AMDG. It appears that other providers in this state are doing the same thing.
Given that there is immense patient pushback on this initiative, you'd think that one of the health care companies in the state would seek a competitive advantage by rolling out a friendlier control program that still satisfied the state guidelines. That's not happening.
Similarly, these companies are being absolutely brutal in the application of their program. Doesn't seem like a good way to increase your share in a competitive market.
The anti-opioid initiatives popping up all over the country aren't stochastic events. As FDR observed, "Everything happens for a reason."
In response to Terry M (above) -- I never heard any more about that lawsuit after its initial filing. Along the way, however, PRN (Pain Relief Network) was forced to discontinue operations and its leader, Siobhan Reynolds, was killed in a plane crash. So, the suit was probably dismissed or withdrawn, but I cannot say for certain.
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