Advocacy and Education

The Painful Truth

• 10.5 million Canadians (~30%, or one in three) suffer from chronic pain

• 2 million Canadians suffer intractable, high-impact chronic pain, and most of them need opiate medicine to function and stay alive

What we know about class action lawsuits

Updated July 27 2019

Patients ask if CPAC can sue government on their behalf for limiting their access to opiate medications.  We've tried to investigate the question thoroughly.  If you have information other than what we say below, please let us know.

Lawyers tell us it's generally not possible to sue government individually or as a class over public policy.  (That would include the 2017 Guideline for Opioids for Chronic Non-Cancer Pain, since Health Canada funded it.)   They also tell us we're unlikely to find a firm to bring a class action.   Firms bringing class actions take a cut of awards or settlements as payment rather than have clients pay upfront.  These cases therefore need to have a very high chance of succeeding, which makes them especially hard to bring.

It's possible that one day Canadians with enough resources and patience will be able to challenge government's prohibition policy on the grounds that it violates the Canadian Charter of Rights and Freedoms.  We've so far been turned down by the Justice Centre for Constitutional Freedoms, which says it believes we have a sound complaint for a charter challenge but doesn't have the resources to pursue it on our behalf.       

If you get your own advice on bringing a lawsuit for medical malpractice or human rights violation (most lawyers aren't able to comment much on the prospects of charter challenges), please share it with us.  You'll have to pay a lawyer upfront to bring an action on your behalf, but usually just to get an opinion on your prospects, your local law society will send you to the right kind of lawyer for a half-hour consultation at no charge.  We advise you to expect that most lawyers think medical opiates lead to addiction and you're best off them, so you'll typically have that hurdle to overcome first.

We wish we had better news about the prospect of lawsuits.

As we come together nation-wide with ever-more voices, perhaps one day we will.

CPAC Blog Archive (2018 and prior)

Opioid medicine effective for chronic pain - study

May 10th, 2018

Opioids have been around for centuries and have been used to provide relief from pain. But, are they an effective treatment? Are they worth the risk of addiction? Do they improve quality of life?

Millions of people with chronic pain do use prescription opioids so they can work, sleep, bathe, and do simple everyday household chores and would answer "Yes" to all those questions.

But, that's a radical concept in an age of anti-opioid hysteria and propaganda. Prominent anti-opioid activists insist that "opioids are ineffective or can worsen both pain and the long-term outlook." And recent opioid prescribing guidelines, in Canada and the United States tell us there is "insufficient evidence to determine long-term benefits of opioid therapy for chronic pain." Except now there's a review that says opioids are effective and the evidence was there all along.

Teams of researchers from Brown University and Tufts University School of Medicine analyzed 15 clinical studies performed for the Food and Drug Administration that looked at the effectiveness of opioids in treating chronic non-cancer pain. Their findings were just published in the Journal of Pain Research.

"The recent claims that opioids lack efficacy for chronic pain have created controversy among physicians, prescribers, regulators, scientists, and the general public," wrote lead author Nathaniel Katz, MD, president of Analgesic Solutions and a professor of anesthesia at Tufts University. "This review was, therefore, performed in order to gather together key evidence to facilitate understanding opioid efficacy within the paradigm of FDA studies required for approval, and to perform a meta-analysis in order to quantify opioid efficacy for chronic pain."

The authors are careful to note they did not try to study or minimize the risks of opioids, but were simply trying to reach an accurate assessment of their benefits. The 15 placebo controlled studies they reviewed evaluated the effectiveness of hydrocodone, oxycodone, tramadol and other opioids for up to 3 months. "There is an ample evidence base supporting the efficacy of opioid analgesics for at least 3 months' duration," Katz wrote. "This evidence base is at least as large as that for any other class of analgesics, and analysis of responders demonstrates clinically meaningful improvements."

Nearly two-thirds of the patients (63%) who participated in the 15 studies demonstrated "a clinically meaningful response" to opioids as a treatment for chronic pain. Their physical function only improved marginally and researchers say there was no positive or negative effect on the patients' mood. Interestingly, adverse effects were similar in the patients who took opioids and those who were given placebos. In short, the authors found no reason to abandon opioids as a treatment for chronic pain. "While the effectiveness of existing treatments for chronic pain leaves plenty of room for improvement, and considering that only a small minority of patients do not experience clinically meaningful treatment response, discarding all analgesics approved for chronic pain contradicts numerous treatment guidelines, international treatment guidelines, widespread patient experience, and the FDA approval process." they wrote.

Critics will no doubt question why the authors only reviewed studies that lasted 3 months or less. The answer is that high quality, placebo controlled studies longer that that simply don't exist. Long term safety and efficacy studies are not required for a drug to get FDA approval--which is why many anti-opioid activists and the CDC claim there is "no evidence" or "insufficient evidence" that opioids work long-term. It's also a misleading statement, because non-opioid pain medications and alternative treatments are not studied for long periods either.

"The reason for the 3 months isn't because there aren't good studies that go beyond 3 months but that 3 months is the period of time the FDA requires for efficacy studies. It is the regulatory standard for assessing long-term efficacy of placebo-controlled studies in chronic pain conditions," explains pain management expert Lynn Webster, MD, who is vice president of Scientific Affairs at PRA Health Sciences. Webster says there are technical and ethical reasons researchers do not conduct longer studies of analgesics.

"It is very difficult to conduct longer studies that are placebo controlled because of the number of dropouts in the placebo arm and the ethical concerns of denying patients access to treatment," says Webster. "It is true there aren't placebo-controlled studies longer than 3 months, but there are extended open label studies that are 12 months. As the article states, these extension studies show the efficacy (of opioids) is maintained."

Katz and colleagues have worked as consultants to Endo, Pfizer, Purdue Pharma and other opioid makers, which they disclose in their article. Funding for the study was provided by Analgesic Solutions and several pharmaceutical companies.

Source: Pat Anson, editor, PNN.

The unintended victims of the war on opiate abuse: legitimate pain patients

November 4th, 2017

By: Barry Ulmer

We all feel sympathy for lives lost from overdoses and the pain felt by their family and friends. Addiction is complicated as are the solutions, but care must be taken to ensure that collateral damage to innocents with chronic pain does not result.

EDMONTON, Alberta - Oct.30, 2017 - PRLog -- November 5 is the start of Pain Awareness Week and so we should consider the new plight those with chronic pain are suffering as the result of the opiate deaths being experienced throughout North America. One of the more common solutions for those with chronic pain is opiate medications.

These medications are effective and enable those with chronic pain to have an improved quality of life. With the careful prescribing by physicians, addiction and abuse is limited and is estimated to be less than 1%. According to Dr. Sally Satel, a psychiatrist experienced in addictions writing in National Affairs:

"The vast majority of people prescribed medication for pain do not misuse it, even those given higher doses. A new study in the Annals of Surgery, for example, found that almost three-fourths of all opioid pain relievers prescribed by surgeons for five common outpatient procedures go unused. In 2014, 81 million people received at least one prescription for an opioid pain reliever, according to a study in the American Journal of Preventive Medicine; yet during the same year, the National Survey on Drug Use and Health reported that only 1.9 million people, approximately two per cent, met the criteria for prescription pain-reliever abuse or dependence."

The deaths we are seeing from opiate abuse occur with drugs bought from dealers rather than prescription drugs and involve illicit rather than prescribed fentanyl. This fact has been attested to by the coroners for both Alberta and British Columbia.

In a recent webinar by the Canadian Agency for Drugs and Technologies in Health (CADTH), Dr. Hakique Virani, a public health specialist from Alberta, pointed out that prescriptions for opiates are declining. Despite that decline, deaths from opiates are increasing. Clearly, prescriptions from doctors are not the problem, nor have they ever been. He also mentions the starting opiate of choice for those addicted is heroin. Heroin is not a drug prescribed by doctors.

The Canadian Pain Society cites statistics from the Canadian Tobacco and Alcohol and Drug Use Monitoring Survey. They show that opiate use has dropped from 20.6 per cent of Canadians reporting use of an opiate in 2010 to 15 per cent in 2013, while use to get high has remained at 0.2 per cent.

Despite the fact that people in pain are not the cause of the addiction problem and the deaths that we are seeing, governments have decided to make it difficult for these patients to acquire medications they need to make their lives bearable.

The former Canadian Minister of Health, Jane Philpott, commissioned a new set of guidelines for the prescribing of opiates by doctors from McMaster University, which did not include any specialist in pain treatment. These guidelines resulted in 4 patient representatives involved refusing to have their names associated with it. The guidelines severely limit the amount of opiates that a patient can have to 90 mg of morphine equivalent per day when the median dose is actually 180 mg. These guidelines recommend that patients be tapered from their current stable doses; many have been on for years.

While this tapering of patients is supposed to be agreed upon between the patient and his/her doctor, the Colleges of Physicians and Surgeons (the regulatory bodies in each province) are investigating doctors who treat pain patients and threatening their licenses. The Ontario Ministry of Health turned over the names of all high prescribing opiate physicians to the "College" for investigation.

What is happening is exemplified by the case of a 76 year old man in Ontario who has been stable on a dose of opiates for years. His doctor is forcing him to reduce his dose despite the fact that it is causing him considerable pain and restricting his quality of life. Also the case of a middle aged man being tapered suffering a heart attack and who is now blind in one eye. There are many more.

As a solution, the doctor suggested to the 76 year old man to go to a methadone clinic. These clinics are usually for those addicted so, as a retired police officer, he was reluctant to do that.

Some pain experts have warned the policy to limit opiates for legitimate use will increase overdose deaths as pain patients will be forced to get their medications from the street. This is already happening. The CBC in Ottawa recently reported on one person who has been forced into street heroin at $80 per day from his usual $2 per day prescription. He had been taking opiates for the pain of Crohn's and Colitis since the age of 12 successfully and had a good quality of life until his doctor forced him to reduce his dose. Reports from other jurisdictions suggest this is a growing problem.

In B.C., the CBC also reports thousands of people are being forced to take street drugs including a 60 year old woman because their doctors have cut them off their pain medications. This simply compounds a street drug problem this province has had for years.

Government does need to react to the opiate abuse situation and attempt to ameliorate it, but it should not be done on the backs of innocent people who suffer from chronic pain. In fact, limiting the availability of medical narcotics to patients is a violation of the UN Single Convention on Narcotics, which Canada signed. The present approach to this problem is reminiscent of the 1930's and Prohibition. The only winners were those involved in criminal activities, much the same as today.

Misguided Strategy to Deal with Opioid Overdoses Targets Legitimate Patients in Chronic Pain

September 5, 2017

FOR IMMEDIATE RELEASE                                                                                                                                                                                                                                                         

Misguided Strategy to Deal with Opioid Overdoses Targets Legitimate Patients in Chronic Pain

Doctors across Canada are being forced to taper and "discontinue" patients in severe chronic pain from the medication they need. The result? A return to pain and disability and, in some cases, suicide.

At a loss as to how to deal with the increasing overdose deaths across Canada by addicts who use drugs illegally, the then federal Health Minister, Dr. Jane Philpott summoned "experts" to a conference in Ottawa last November. Sadly, as the Ottawa Citizen wrote, pain specialists and patients were not included in any of the presentations, and results were consequently ill-informed. Only two pain patients were invited, and at the last minute one pain specialist was allowed in, though not to speak. The conference determined that epidemiologists at McMaster University in Hamilton, Ontario should rewrite Canada's 2010 opioid prescribing Guideline.

The 2010 Guideline, agreed to by specialists and medical organizations across Canada, worked well. Patients in chronic pain (1 in 5 Canadians) were able to get needed relief and medication as required as long as it improved their pain, quality of life and had few side effects. No one has explained why we needed a new one.

The McMaster Guideline was said to be developed in extensive consultation with stakeholders, but it appears decisions were ultimately made by a four-person steering committee chaired by Dr. Jason Busse, a chiropractor who can't prescribe, but who is nonetheless an associate professor of anaesthesiology at the University. The new Guideline slashes medical opioid use by as much as 90% by advising doctors to taper and "discontinue" medication to otherwise stable and productive patients who've enjoyed some quality of life--in many cases, for decades. Several patient advisors to the Guideline committee have withdrawn their names from the final document, which has been loudly derided by many well respected pain specialists.

Driving this effort is the myth that street drugs have been diverted from legitimate prescriptions, despite reports from the Alberta and British Columbia coroners to the contrary, and despite objections from pain experts. Additionally, the well-respected and representative National Survey on Drug Use and Health reports that 70% of all opioid misuse starts with medication not prescribed for the misuser. Moreover, 90% of all addictions--no matter to what--start in adolescents and teens who, for the most part, are unlikely to be prescribed opioids long-term.

 "Dismissed" or "tapered" patients are now contemplating suicide, and some have died. In B.C., where the allowable dose is even lower than the rest of the country and where doctors are prevented from prescribing more, one patient told the Roy Green Show that she had her lawyer request assisted suicide on her behalf. The lawyer also told the B.C. regulatory college her estate would sue for wrongful death.

Among other evidence it's missed or ignored, the new Guideline overlooks a significant 2010 Cochrane Review of nearly 5,000 patients on opioids long-term, all of whom reported "clinically significant reductions in pain," with addiction occurring in only 0.27%--a mere 13 patients out of 5,000. Opioids work for people in pain. Almost none, when properly screened for addiction precursors, get addicted.

 A report, just issued in Ontario, found that doctors are prescribing fewer opioids to patients in pain. McMaster's Dr. Busse called the trend "encouraging." Unless, of course, if you're in pain with your medication reduced--or even worse gone.

 For further information, contact Barry Ulmer: (780) 482-6727.

 About The Chronic Pain Association of Canada: CPAC is a large network of pain patient support groups in Canada governed by a volunteer Board of Director. CPAC is a not-for-profit association whose goals are to, when possible, create timely, effective treatment for all those who suffer with pain; to provide support when possible for those suffering and to improve the area of education and understanding in pain medicine.

More myths about high-dose opoids and death

September 20, 2016

By: Barry Ulmer

Past studies and commentary have claimed that higher opioid analgesic doses increase mortality rates; yet the research methods used to establish this should be challenged by critical readers. A data-mining investigation by Canadian investigators is a good example of how evidence can be statistically manipulated to arrive at outcomes with questionable validity, perpetuating myths of opioid harms that may not truly exist.

According to Tara Gomes, MHSc, and colleagues, writing in the Archives of Internal Medicine, opioids are often prescribed for chronic non cancer pain at doses exceeding those recommended in clinical practice guidelines and this incurs increased mortality. To examine the risk-benefit ratio of such high-dose opioid therapy they developed a retrospective, population-based, case-control investigation, spanning more than a 9-year period. Subjects came from a database of residents in Ontario, aged 15 to 64 years, who were eligible for publicly funded prescription drug coverage and had received an opioid analgesic for non-malignant pain.

The primary outcome of interest was cases of opioid related deaths, as determined by the investigating coroners, compared with control subjects, who were persons receiving comparable analgesics during the 9+ years’ time period and did not die of opioid related causes but were otherwise matched to the cases on an array of characteristics. The risk of opioid-related death was compared across patients treated with varying daily doses of opioids: 1-19mg/day morphine or equivalent dose(MED) was the reference category, as compared with 20-49, 50-99, 100-199 and greater than 200mg/d MED.
Among 607,156 persons aged 15 to 64 years prescribed an opioid during the study period, the researchers identified 498 eligible case patients whose deaths were allegedly related to the opioids, and 1,714 matched controls. After extensive adjustments for multiple clinical and demographic factors, they found an average daily dose of greater than 200mg/d MED was associated with a nearly 30fold increase in the "risk" of opioid-related mortality (Odds Ratio [OR] =2.88; 95% Confidence Interval [CI] 1.79-4.63) relative to low daily doses (less than 20 mg/d MED). They also reported lesser but significant increases in opioid-related mortality with the intermediate doses of opioids (50-99 mg/d MED, OR=1.92, 95% CI 1.30-2.85; and, 100-199 mg/d MED, OR=2.04, 95% CI 1.28-3.24.
The authors conclude that among patients receiving opioids for non-malignant pain, the daily dose is strongly associated with opioid-related mortality, particularly at doses exceeding thresholds recommended in recent clinical guidelines (e.g., more than 200mg/d MED). They state, "We believe physicians should carefully assess the appropriateness of long-term use of opioids to treat chronic, non-cancer-related pain, particularly at high doses."

COMMENTARY: The best that can be said of data-mining ventures such as this study is that they are sophisticated computerized simulations of what might be occurring in a particular population, that they are suggestive rather than confirmative of any cause-effect relationships, and that they have considerable limitations and sources of bias. Unfortunately, the results are too often widely accepted as fact, cited in the literature, and become part of a growing mythology of opioid risks.
This study is yet another example of how opioid harms have been "myth-represented" via the creative use of data mining and statistical prestidigitation. We will leave the most disconcerting observations regarding this study for the end and will first focus on some questionable evidentiary points.

• All subjects in the database were aged 15 to 64 years who qualified for the Ontario Public Drug Plan; this included patients on disability, residents in long-term care facilities or receiving home care services, and unemployed or economically disadvantaged persons. Therefore, this was a select population at the outset that may not typify the general public--hence, external validity is doubtful.

• Opioid-related mortality was derived from coroner determinations that "a combination of drugs (including more than 1 opioid) resulted in death, or those in which forensic toxicology testing revealed opioid concentrations sufficiently high to cause death...." Such assessments have been disputed in past research, in that (a) the opioid(s) in question may be merely present as part of a mix of agents but not directly or solely causative of death, and (b)the post-mortem concentration in serum or blood of any opioid that is judged as representing toxicity in a given person depends on multiple factors and is usually vaguely defined. Case subjects in this study were taking greater percentages of antidepressants, and methadone that were control subjects. Alcohol use was unaccounted for, but about 85% of case subjects were using benzodiazepines compared with only 64% of controls, which may have influenced mortality when combined with opioids or alcohol. Furthermore, the authors included all types of opioid-related deaths in their analyses, including nearly 17% of which were suicide and probably unrelated to the prescribed opioid dose itself (unless the dose was so inadequate that decedents has intolerable pain).

• In lieu of an examination of individual patient charts, the researchers had to use complex and imprecise algorithms to determine opioid dosing. The authors state that they "estimated the average daily dose as the total quantity of opioids intended for use in the 120 days prior to the index date (in milligrams or morphine equivalents) divided by 120" [emphasis added]. There was no way of knowing the exact prescription subjects received, if they took the opioids as prescribed, or if they supplemented their prescriptions with additional opioids or other agents that went unrecorded in the database. Therefore, at most, we must assume the researchers were only guessing at dosing regimens and patient compliance, and the accuracy is questionable.
• A comparison with less than 20 mg/d MED as a reference was probably inappropriate, since it is unlikely that persons with serious chronic pain conditions would benefit from such a low dose on a consistent basis. The authors do not indicate how many case and control subjects were in this category, but using such a low threshold as a reference point probably arbitrarily inflated the odds ratios in the other dose categories.
• Furthermore, in letter to the journal editor, Owen Williamson, MBBS, looking closely at the data, pointed out the proportions of deaths (or event rates) for cases in the 20-49 mg and the greater than 200 mg categories are identical (0.23), and the lower dose range (20-49mg) -- with its confidence interval crossing 1.0 -- was not significantly different statistically from the reference range (less than 20mg). In addition, the odds ratio confidence intervals overlap for all dose categories, suggesting that mortality is not associated with opioid dose alone.
  
• In a rebuttal letter, the researchers claim Williamson misinterpreted their study. They asserted that in data not published in their article "the association between dose and opioid-related mortality was consistent in our unadjusted conditional logistic regression model for primary outcome..." Furthermore, while "the 95% confidence intervals overlap between high and moderate dose categories, a clear and significant association between higher doses of opioids and opioid-related mortality is apparent in both unadjusted and adjusted models." However, using unpublished data, inaccessible to readers, as a defense is questionable and, at any rate, this neither supports a hypothesis that doses greater than 200 mg/d MED are most hazardous nor that moderate doses are clearly distinct from 20-49 mg/d MED (which is not statistically different from less than 20 mg.)

• As is typical in research of this sort, outcomes are presented as odds ratios that are easily misleading and misunderstood by readers. For example, Gomes et al. claim that greater than 200 mg/d MED doses were associated with nearly a 3-fold increase in the "risk of opioid related mortality." Actually, this was a 3-fold increase in the odds (OR=2.88) not the risk; the relative risk increase for greater than 200 mg/d, which is calculated from their data was 0.76 and the absolute risk difference between cases and controls in the study data for this category was only 0.10. The authors’ further claim their study demonstrates "a substantial increase in the relative risk of opioid-related mortality associated with high opioid doses," but they do not calculate those risks for the reader. And, they acknowledge indirectly that, while absolute risks in the overall general population cannot be determined by their study methodology, such risks would likely be small. This brings into question the rationale behind their argument for this study’s relevance or importance.
• When examining end points such as deaths attributable to a pharmacotherapy, randomized controlled trials are inappropriate and likely unethical. However, retrospective case-control studies such as this pose many challenges, particularly in the selection of adequate subjects to serve as controls. In his letter Williamson observed, "It is apparent the authors had difficulty matching cases and controls. The authors acknowledged the inability of the disease risk index to control for important confounders by stating 'as expected, cases and controls differed on baseline characteristics associated with the risk of addiction and drug-related adverse events.' There was also a significant decrease in matched controls with increasing dose categories." Therefore, Williamson contended, the ability of statistical techniques to adjust for imbalances in the many confounding factors between groups must be questioned and the true contribution of opioid dose as a cause of death is dubious. In their response letter, Gomes et al. acknowledge that "we did not report the proportion of cases in each dose group that were successfully matched in our original article, but in fact the proportion of cases fully matched to 4 controls did not differ substantially among groups (range, 81.1% to 84.1%, including 83.2% among people prescribed 200 mg.d of MED." Besides referring to unreported data again as a justification, the authors seem to be conceding that there was indeed a degree of mismatching across all groups. While sophisticated statistical manipulations can be, and were, used to adjust for this, as well as for an extensive list of potential confounders other than opioid dose that might have affected outcomes, at some point it must be considered that statistical manoeuvring can only go so far before a study lacks validity.

In an invited commentary accompanying the article by Gomes et al., Mark Sullivan, MD, PhD, with the University of Washington School of Medicine, notes that the evidence of mortality risks inherent in high-dose opioid therapy in the present study is consistent with earlier investigations, such as that by Dunn and colleague. However, we have previously assessed fallacies of the Dunn et al. investigation and warned at that time it might someday be wrongly touted as evidence to support similarly flawed research -- as it is by Sullivan.

Both Gomes et al., and Sullivan note that mortality risks were observed to be elevated at doses exceeding thresholds in recent clinical guidelines. One of these they reference is from the APS/AAPM (American Pain Society/American Academy of Pain Medicine), which actually does not advocate against higher opioid dosing and, in fact acknowledges there is insufficient evidence to support their own consideration of more than 200 mg/d MED as being a high dose -- in short, the 200 mg/d threshold was just a "best guess" of the guidelines panel based on very limited evidence of any quality. Then, using both the Gomes et al. and Dunn et al. studies as a justification, Sullivan notes how his own state, Washington, has adopted a 120 mg/d MED benchmark ceiling of opioid prescribing for chronic non-cancer pain, and higher doses would require special considerations or actions by healthcare providers prior to continuing therapy. However, even while imposing this rule, state authorities waffled on this point by conceding there is no predefined 'safe' opioid dose and that more than 120 mg/d MED is not necessarily unsafe.
What is clear is that the so-called evidence for increased mortality risks of opioids at arbitrarily determined higher doses is unclear, or at best weak. Yet, many researchers and even legislators and government agencies seem to accept that a collection of weak evidence amounts to strong proof that favours putting limits on opioid dosing. This faulty and unscientific reasoning brings us to some of the most disconcerting points expressed in these articles...

1.      Sullivan states in his commentary that, even though absolute risks of mortality associated with high-dose opioids is low, "death due to therapy for a non-progressive, nonfatal condition must be taken seriously" [emphasis added]. This implies that chronic pain is neither a progressive nor fatal condition that justifies the alleged risks of higher-dose opioid therapy affording pain relief. To say the least, this is an uninformed, biased and detrimental perspective. Prior research has demonstrated a profound link between severe chronic pain and death; inflicting nearly 70% greater mortality risk than even cardiovascular disease. And, in his letter to the editor, Williamson observes that evidence of an association between suicide rates and pain severity would suggest that chronic pain can indeed be fatal. Similarly, the association of unrelieved chronic pain and suicide are stark.

2.      However, in their rebuttal letter, Gomes et al. state: "[W]e agree with Dr. Williamson that chronic pain may be so severe that it increases the risk of suicide. However, given the absence of evidence that high-dose opioid therapy reduces the risk of suicide and the presence of evidence that many individuals commit suicide with opioids, the risk of suicide is yet another reason to prescribe opioids particularly cautiously to individuals with chronic non-malignant pain" [emphasis added]. The implicit logic of this argument is abhorrent; that persons with chronic pain -- possible severe and unrelieved pain -- may use their opioid medications to commit suicide and, therefore, they should be prescribed lower doses or denied opioids altogether!

3.      Lending a voice of greater reason, Williamson concludes his letter by stating, "It is important to ensure the safety and efficacy of any treatment for chronic pain by identifying and managing patient risk factors for adverse outcomes. However, it is equally important not to set arbitrarily limits on a given treatment if it can improve quality of life for patients with this common and poorly treated condition."

Besides ramifications for negatively affecting the well-being of patients with chronic pain, another serious concern about this sort of research is that, with the increasing implementation of electronic medical records and the vast reservoirs of data they represent, we will probably see ever more investigations taking advantage of data mining, often called "data dredging," techniques. Our concerns are these approaches could (and have) produce a flood of misleading "pseudoscience" that will be more of a hindrance than a help in furthering better care for patients with pain.

Many questions about opioid safety -- patient selection, maximum effective dosing, toxicity and associated mortality, etc. -- are difficult to approach using high-quality research designs, such as randomized controlled trials. However, methodologies like data-mining generally provide only "soft answers" to those "hard questions," and we should not accept these studies as valid or incontrovertible evidence. It is important that readers understand the limitations of these studies, can assess their flaws, and put the results into proper perspective to reach their own conclusions.

Source: SB. Leavitt, MA, PhD.

War on Pain Patients

July 21, 2016

By: Barry Ulmer

Over the past several years there has been an ongoing methodical attack on people in pain. Although the rhetoric has been levelled at opioids it has had a direct and deleterious effect on people suffering with pain. What is even more concerning is, those feeding this rhetoric against the use of opioids in this area of medicine, are pushing their agenda by using the tragic consequences happening to people who use ILLICIT substances. The climate out there is hostile, ignorant, and misinformed, illegal drug numbers, emergency room visits and overdose deaths are linked with legitimate prescriptions and the media do not vet these numbers or even question the relevancy of such numbers. It seems the media learned nothing from the debacle they created with "Jimmy's World", a completely fabricated story about drugs. The prohibitionists have utilized spurious figures garnered from studies that have used "data dredging" to obtain their information; in addition to information that everyone classifies to be of low scientific value. Their use of Scientism is also egregious. When someone questions their speculations they attack their character and integrity--a sure sign they know full well their own arguments have little merit. Moreover, media coverage rarely includes the perspective of pain patients--or does so only to knock those who advocate for proper access to opioids as pawns of the pharmaceutical industry. We do have a growing illegal drug problem where addicts have issues that need to be addressed. The drama of their situation is being used as a weapon against pain patients. Few average pain patients have enough "drama" to even warrant media attention with a two line story, so the strategy has become, to lump the truly ill with the dramatics of the drug addiction problem. These attacks have only stalled progress in the area of pain, and have sent the treatment of chronic pain reeling backwards into ignorance and fear. The extreme negative media attention is not only making it difficult for legitimate patients to get the medicine they need, it is making them afraid of taking it when it is prescribed to them.

The international war on drugs has been a costly failure that has created a "public health and human rights crisis," says a report commissioned by the United Nations, who recently met to discuss drug policy. A 54-page report by the Johns Hopkins--Lancet Commission on Drug Policy and Health indicates many drug policies are based on ideas about drug use and dependence that "are not scientifically grounded" and are particularly harmful to people in pain. The commission estimates about  5.5 billion people worldwide do not have adequate access to controlled , medicines for the management of pain.

"Inequality of access to controlled medications for pain management and other clinical uses is now a public health and human rights crisis," the report says. "yet, the obligation to prevent abuse of controlled substances has received far more attention than the obligation to ensure their adequate availability for medical and scientific purposes, and this has resulted in countries adopting laws and regulations that consistently and severely impede accessibility of controlled medicines." Abolitionists here in Canada and the United States continue to use the concept that we are in the top 10 prescribers of these medications, which is indeed true, however, what they fail to mention is this in not hard to do as, according to the INCB, about 90% of countries have such strict regulations their citizens don't have access to them, even for the disease of cancer. This approach is drive by the current rash of deaths from the use of ILLICIT substances smuggled in from China and Mexico, but all reports mesh that into the use of legitimate medication.

 The commission said there were many "myths and exaggerations" about opioid use that have stigmatized people who use these medicines. And rather than lowering the risk of abuse and addiction, prohibition was making the problem worse by forcing many people to turn to the street for opioids. "Prohibition creates unregulated illegal markets in which it is impossible to control the presence of adulterants in street drugs, which add to overdose risk," the commission pointed out. "The idea that all drug use is dangerous and evil has led to enforcement-heavy policies and has made it difficult to see potentially dangerous drugs in the same light as potentially dangerous foods, tobacco and alcohol."

This has led to a number of counterfeit pain medications laced with fentanyl and heroin, coming from China that are responsible for many overdose deaths. These fake pain pills have appeared, as a number of Canadians, in collaboration with prohibitionists in the United States, put forward new guidelines by the Centers for Disease Control and Prevention (CDC) that strongly discourage primary care physicians from prescribing opioids for chronic pain. Many patients, who have been on stable doses for years, now fear losing access to opioids because these guidelines and the myopic view of these prohibitionists has promulgated to policy-makers and regulators. "Policies meant to prohibit or greatly suppress drugs are a paradox. These policies are portrayed and defended vigorously by many policy makers as necessary to preserve public health and safety, yet the evidence suggests they have contributed directly and indirectly to lethal violence, communicable disease transmission, discrimination, forced displacement, unnecessary physical pain, and the undermining of people's right to health," the report concluded. In fact, Debra Houry, MD, Director of the CDC's National Center for Injury Prevention, stated: "It (the guidelines) is not intended to deny access to opioid medication as an option for pain management. It is not intended to take away physician discretion and decision-making".

We have for years stated we would have a national policy on euthanasia before one on pain relief. The efforts to bring pain relief to people in pain continue to be overshadowed by the very visible and vocal movement that exploit's people's fear of pain, but offers only death as an answer have borne fruit. Now add the selective misapplication of reports on ILLICIT substance abuse to the equation we have moved even further away from making the lives of millions of Canadians somewhat bearable.

Barry D. Ulmer

Executive Director

The Chronic Pain Association of Canada

A real need for pain management

March 23rd, 2016

Today we have an onslaught of negative reports on the use of medication to treat chronic pain. These specious attacks have affected every area of pain medicine in an extremely negative manner causing more and more pain for those who suffer, even those who don't require medication. Lost in all the condemnations, proclamations and recommendations about pain treatment is a most basic scientific fact about pain. Its first and foremost impact, other than agony, is its dramatic, aggressive assault on the cardiovascular system. Check with your neighbourhood medical consultants: 5th grade students. The boy who encounters a splinter and the girl playing hopscotch who twists her ankle will both tell you their pain causes their heart to race. Better yet, go to your ultimate peer review consultant: your grandmother. She well remembers the stories and days when women commonly died due to the pain of childbirth when the heart stopped or a brain stroke occurred. Thank god we now have opioids, channel blockers, and muscle relaxants--if only those who regulate or pay for them will let physicians prescribe them!

Ignorance about the cardiovascular consequences of pain is profound even among some learned pain specialists. First, some basics. Acute and chronic pain, being the ultimate stress, causes a flood of adrenalin and related compounds to be released from the adrenal and pituitary glands. The most obvious, discernable, and easily measured consequences are an elevated pulse rate and blood pressure. Secondary physiologic consequences of excess adrenalin in the blood may include, in the short run, lipid abnormalities, cardiomyopathy, stroke, arteriosclerosis, and heart failure. Perform a little test to demonstrate the consequences. Check the pulse rate on the next patient you encounter who complains of constant, severe pain. Don't be surprised to find a resting pulse rate over 100 per minute. It's shocking. but many under-treated, intractable pain patients maintain pulse rates over 88 and sometimes over 120. This editorial was, in part, motivated by a "failed back surgery-autoimmune-tried everything-consulted everybody" patient now on two opioids who e-mailed me telling me her pain is poorly controlled and accompanied by a house-bound state and her at home pulse rates over 100. Naturally, pulse rates this high call for more aggressive pain control such as another epidural, dosage increase, or an ancillary pharmacologic agent. Bottom line is that effective pain treatment must strive to bring pulse rates and blood pressure into normal ranges.

Cardiovascular consequences, including heart stoppage, stroke, or heart failure are among the most common, if not the most common, causes of death in chronic and intractable pain patients. Clearly pain will aggravate any pre-existing cardiac, lipid, or diabetic condition. One of the travesties of scientific ignorance is that a number of physicians have been erroneously accused of malpractice after one of their pain patients died. Too often coroners and other onlookers jump to the false conclusion that pain medication and an "over-prescribing" doctor cause the death when in actuality the patient died a cardiovascular death from under-controlled pain. Just as in childbirth, a sudden severe pain flare can cause excess adrenalin output, cardiovascular collapse, with sudden death. Another common cardiac manifestation is unrecognized congestive heart failure. It can cause sedation and sleepiness and can easily be confused with medication overdose. The treatment here is digitalis rather than Naloxone.

Without question, detoxification and withdrawal of medications from a bonafide, intractable pain patient may come to rank as one of the great medical frauds of the 21st century. The notion that intractable pain patients are somehow better off with no medication and debilitated with pain is absurd and dangerous. Pain patients and families, in order for some outfit to make the big detox bucks, have actually been told that opioids and other pain medications are the cause of pain and that the patient will be "cured" by detoxification. Many intractable pain patients have died of cardiovascular collapse when their pain flared during too aggressive withdrawal from medication. Any ethical physician who attempts detoxification of a chronically medicated pain patient must monitor the pulse rate and blood pressure and be prepared to cease withdrawal and reinstate medication if the pulse rate or blood pressure rise.

Regular pulse and blood pressure monitoring should be routine practice in pain treatment, and patients and families should self-monitor at home in severe pain cases. This author recommends that pulse rates be kept below 88, and pain treatment should progressively and aggressively increase in intensity to bring the cardiovascular system into normal homeostasis with a pulse rate of 68-76. Without good cardiovascular control, the lifespan of an intractable pain patient will be cut short.

This author recommends that intractable pain patients and their families buy an inexpensive at-home pulse and blood pressure monitor and provide a monthly report on the results. There simply isn't a cheaper, better and objective marker of uncontrolled pain than a pulse rate.

Forest A. Tennant, MD, DrPH.

Practical Pain Management Journal.

Opiates relieve chronic pain with little addiction risk

March 22nd, 2016

By: Barry Ulmer

According to a comprehensive Cochrane review, opioid analgesics effectively relieve chronic non-cancer pain in most patients, with only a small (though not zero) risk of developing abuse or addiction. However, it must be appreciated that a portion of patients may have inadequate pain relief or develop intolerable side effects; care must be taken to identify patients who will benefit most.

Over the past few years there has been an ongoing move to vilify opioids in the management of pain, which leaves the subject controversial with concerns about long-term effectiveness and safety, particularly risks of tolerance, dependence and abuse. To expand and update an earlier Cochrane Review on this subject, investigators searched 10 bibliographic databases and discovered 26 studies with 27 treatment groups that enrolled a total of 4,893 participants taking opioids for as long as 48 months. Twenty five of the studies were case series or uncontrolled long-term trials, the other was a randomized controlled trial comparing two opioids. Within each trial a portion of the participants discontinued opioid therapy due to side effects and a number due to insufficient pain relief. Serious adverse events were rare and signs of opioid addiction were reported in only 0.27% of participants in the studies that reported that outcome. All methods of administration were associated with clinically significant reductions in pain in the majority of patients, but the amount of pain relief varied across the studies.

Cochrane reviews -- following well-developed protocols for data research, extraction, analysis, and validation of findings -- are perhaps the most rigorous and robust approaches for assessing current knowledge of particular therapies. In this analysis of studies evaluating long-term opioids for chronic non-cancer pain, both the quantity and quality of evidence were of some disappointment so it must be said although the results were interesting it is supposed better and longer-term trials should be taken to help identify patients who are most likely to benefit.

Source: SB. Leavitt, MA,PhD - Pain-Topics

New target for reducing nerve pain, identified

March 2nd, 2016

Hiroshima University researchers have identified a specific molecule that maintains pain after a nerve injury and have been able to block it in lab animals. This discovery may reveal a promising therapeutic strategy for treating neuropathic pain.

Lab animals with an injury to their sciatic nerve showed less pain after multiple injections of a medication that blocks the activity of a molecule called high-mobility group box-1 (HMGB1). The team also discovered that a single dose of a substance to block the activity of a different molecule, called matrix metalloprotease-9 (MMP-9), could also alleviate pain from the injury. The chemical pathways these substances use to inhibit HMGB1 or MMP-9 are different from common pain relievers, like opioids or acetaminophen. Therefore, the potential for addiction or negative side-effects may be reduced.

The results reveal that the substance to block HMGB1, called anti-HMGB1, has the downstream effect of preventing the increase of MMP-9 that would normally be expected when HMGB1 increases. Therefore, an inhibitor of MMP-9 may be a more direct route to produce the same effect. This is the first study to link HMGB1 and MMP-9 together in the cellular process of maintaining pain. These researchers, led by Professor Yoshihiro Nakata, PhD, at Hiroshima University’s Institute of Biomedical and Health Sciences began their investigation of sciatic nerve pain as part of their long-term studies of the central nervous system.

Professor Nakata's team demonstrates a pain-relieving effect from injecting anti-HMGB1 into the hip in the slightly broader area around the nerve, called a perineural injection, avoiding the complications of other injection methods. A localized injection also avoids the potential side-effects of delivering the medication through larger body systems, like a pill into the digestive system or an injection into the blood. Blocking HMGB1 lessened pain with no negative impact or healing. Selectively blocking MMP-9 also relieved pain with no obvious changes to the activity of other molecules responding to the injury.

It is surmised these results show promise for relieving nerve pain with a chemically specific approach that is convenient for patients.

Source: Science Daily, 29 February 2016 from Hiroshima University.

Chronic Pain Changes our Immune System

February 16th, 2016

According to a new study by McGill University researchers, published in the journal Scientific Reports, chronic pain may reprogram our immune system.

"We found that chronic pain changes the way DNA is marked not only in the brain, but also in T cells, a type of white blood cell essential for immunity," said Moshe Szyf, a professor in the Faculty of Medicine at McGill. "Our findings highlight the devastating impact of chronic pain on other important parts of the body, such as the immune system."

Chronic pain -- pain that lasts six months or more -- is one of the most common causes of disability worldwide.

The all-McGill team examined DNA from brains and white blood cells of lab animals, using a method that mapped DNA marking by a chemical called a methyl group. "Methyl marks are important for regulating how the genes function," explained co-author Laura Stone, a professor in Dentistry and researcher in the Alan Edwards Centre for Research on Pain. This sort of chemical marking is part of the growing field of epigenetics, which involves modifications that turn genes 'on' and 'off', effectively reprogramming how they work. "We were surprised by the sheer number of genes that were marked by chronic pain -- hundreds to thousands of different genes were changed," added Szyf. "We can now consider the implications that chronic pain might have on other systems in the body that we don't normally associate with pain."

These findings could open new avenues to diagnosing and treating chronic pain in humans, the researchers suggest, as some of the genes found to be marked by chronic pain could also represent new targets for pain medications.

Source: McGill University

Severe pain is a killer, study finds

December 8th, 2015

Previous research has demonstrated a clearly negative influence of chronic pain on health. A study now portrays a profound link between severe chronic pain and death; inflicting nearly a 70% greater mortality risk than even cardiovascular disease.

A large cohort of 6,940 persons was recruited by researchers at the University of Aberdeen, UK, and information collected about chronic pain status, general health, and socioeconomic details [Torrance, et al. 2010]. Follow-up of this cohort linked the data with routinely collected national data for death registration. A total of 5,858 (84%) of individuals from the original cohort were linked, including 1,557 (27%) who had died. The researchers found a significant association between chronic pain and all-cause mortality. Particularly troublesome was severe chronic pain -- survival among persons with this condition was significantly worse than among those reporting mild or no chronic pain. Even after adjusting for various confounding socio-demographic factors and effects of long-term illness, patients with severe chronic pain had a 49% greater risk of death compared with all-causes mortality and a 68% greater risk of death compared with all cardiovascular-disease-related deaths.

COMMENT: The negative impact of severe chronic pain on survival discovered by this research is dramatic and concerning; especially when considering the recent brouhaha about purportedly high risks associated with analgesic agents, particularly opioids. In an objective risk-benefit analysis, it would appear from this study that the increased mortality risks associated with untreated or inadequately treated chronic pain could pose a greater threat than any hazards potentially associated with pain-relieving medication therapies. In brief -- any restrictions on access to effective therapies for severe chronic pain might be tantamount to fostering premature death in the afflicted patients.

SB Leavitt, MA, PhD.

REFERENCE: Torrance N, Elliott AM, Lee AJ, Smith BH. Severe chronic pain is associated with increased 10 year mortality. A cohort record linkage study. Eur J Pain. 2010 (Apr); 14(4): 380-386

Become informed: Separate MYTH from FACT

November 11th, 2015

By: Barry Ulmer

"For too long, pain and its management have been prisoners of myth, half-truths, irrationality and cultural bias. While misinformation about oral morphine and other opioids remains extremely common among healthcare workers, knowledge about how to assess and treat pain is often absent or deeply inadequate." The combination of ignorance among healthcare workers and the myths about opioids results in failure to treat patients who are suffering from severe pain. [1]

Some of the most common myths hold that treatment with opioids leads to addiction -- which is the most frequently cited impediment to the medical use of opioids, that pain is necessary, that it is essential for diagnosis, that it is unavoidable and that it has negligible consequences. Each of these myths is inaccurate. Numerous studies have shown that the treatment of pain with opioids very rarely leads to addiction; most pain can be treated well; pain is not necessary for diagnosis; and pain has considerable social, economic and psychological consequences as it keeps people who suffer from pain(and their caregivers) away from a productive life. [2]

The International Narcotics Control Board is an organization that too often is mistakenly seen as the international equivalent of the U.S. Federal Drug Enforcement Agency (DEA). However, The INCB has repeatedly called for improvements in the treatment of pain. "The low levels of consumption of opioid analgesics for the treatment of pain...continue to be a matter of serious concern to the Board. The Board again urges all Governments concerned to identify the impediments in their countries to adequate use of opioid analgesics for the treatment of pain and take steps to improve the availability of those narcotic drugs for medical purposes." [3]

These and similar statements by the INCB surprised groups----the assumption was that federal agencies and the international agency would share the exact same position on the consumption of opioids. That does not appear to be what is transpiring. It seems federal regulatory agencies in both Canada and the United States are not entirely aligned with the goals of the International Narcotics Control Board. Anecdotal information from pain patients indicates that doctors often cite regulatory board views as the reason patients cannot have access to the type of pain medication necessary to combat the patient's pain. Some medical professionals appear to be genuinely afraid their license to practice medicine may be jeopardized when a regulator arrives unannounced to review doctors' prescribing practices, if that agent is displeased with the amount of opioid pain medication being prescribed (often simply based on counting pills). Other fears are also based on erroneous or half true research papers by biased researchers. While the INCB is searching for ways to eliminate impediments, these regulators and researchers are creating impediments for doctors who prescribe legitimate chronic pain relief for their patients. If regulators are operating under an assumption that there is a connection between the prescription treatment of true pain patients and illegal drug distribution, they must rethink their assumptions. They are not going to end illegal use of medications by creating fear in the doctors who carefully follow the law when they dispense medication to legitimate patients. [4]

Sources:

[1] The World Health Organization, 2009

[2] Human Rights Watch, 2009

[3] International Narcotics Control Board, 2007

[4] The Mayday Fund, 2009

Pain: a chronic disease in its own right

October 23rd, 2013

By: Barry Ulmer

Some headway continues to be made to recognize pain as a disease in its own right so more attention is paid to it. The Pain Society of Alberta recently announced they had worked with the Alberta Medical Association to recognize pain as a chronic disease. This was accomplished and in early October the AMA came out with that announcement. Our thanks go out to Dr. Brian Knight, Dr. Greg Boughen, Dr. Rob Hauptman and Dr. Gaylord Wardell for their tireless work in accomplishing this feat with the AMA.

The PSA announcement went on to say: "Chronic pain affects 1 in 5 Canadians. It is one of the most common reasons for patients to present to their primary care physicians. The cost of chronic pain for Canadians is well over 40 billion dollars in direct and indirect costs. This is more than cancer, HIV and heart disease combined."

The fact that chronic pain is a chronic disease has also been recognized by a number of other organizations that include the International Association for the Study of Pain (IASP).