Honourable Sarah Hoffman
Minister of Health
Government of Alberta
423 Legislature Building
10800 – 97 Avenue
Dear Minister Hoffman:
It was Aldous Huxley who said that fear, “casts out intelligence, casts out goodness, casts out all thought of truth….in the end fear casts out even man’s humanity.” This appears to be even truer today when it comes to the treatment and management of pain in our communities. Over the past several years there has been an ongoing effort by many that has affected every aspect of the field of pain management. The underlying reason for this
is the use of strong analgesics or opioids. The attack on these medications has not only changed how physicians look at these medicines, but has overtly changed how they look at people with pain. Many physicians now often will not take on patients with pain, some have moved to exclude their patients from their practice, with others abruptly reducing stable doses a person has been on for many years to ineffective doses, with still others
taking their patients completely off their medications causing unnecessary suffering.
These physicians suggest people move to a non-pharmacological approach to managing pain, which is fine, but most people have already tried this approach several times and found it ineffective. This simply results in higher costs to, not only the patient, but to our health care system. The sad reality of this is these physicians do this because they fear the wrath of the regulatory body.
The recent announcement by the College of Physicians and Surgeons of Alberta (CPSA) indicating they were establishing “tougher rules on opiate prescribing” has only served to intensify this fear. This “standard of care” pronouncement based on the poorly developed guidelines from the U.S. based Centers for Disease Control and Prevention (CDC) is not the solution to the hysteria surrounding the illicit use of illegal substances. We do have a drug problem in this country, but it is not a prescription medicine problem. What we find disturbing is that the body which is supposedly there to protect patients has taken this step based on poor evidence. As in every guideline developed so far on prescribing opioids the evidence they present is of the “low to very low quality” and involve some skewed data, in addition to being based on more consensus and personal views of those
involved in the writing of the guidelines.
A recent review, published in the Journal of Pain and Palliative Care Pharmacotherapy, indicated that some policies restricting opioid prescriptions with the thought of curbing overdose deaths may be harming those who need them the most: pain patients. The report “Negative outcomes of unbalanced opioid policy supported by clinicians, politicians and the media” suggested the opioid epidemic, some refer to, has been misrepresented by
some politicians and the media. The proposed “standard of care” by the CPSA would fit into that statement. The CPSA is basing their standards and dosage requirements on the flawed guidelines issued by the CDC. Those guidelines were written by a small group of individuals heavily involved in the addiction field, with little or no experience in the field of pain medicine and with close ties to a large addiction Rehab organization. With the
exception of one alleged pain doctor who works for a large law firm suing pharmaceutical companies who manufacture opioids. As one group of medical professional critics pointed out the Guidelines are “Neat, Plausible and Generally Wrong”. Their article and many others have enumerated a profound lack of balance,
science and medical evidence behind the guidelines. It is bewildering why the CPSA would, it seems, in a kneejerk reaction move forward with such a misguided program.
Other research shows the CDC actually manipulated the data it used as a basis for its guidelines. In fact, in its recent Morbidity and Mortality Weekly Report (MMWR) they said “the rise in opioid overdoses had little to do with prescription painkillers. Instead the real culprits behind the spike were heroin and illegally manufactured fentanyl.” The 2016 National Drug Threat Assessment report verifies this. This actually started in 2011, but
because regulators, law enforcement, media-hype and politicians were so intent on blaming doctors for the problem we now find ourselves in the present situation of ILLICIT substance overdose deaths, and people with pain suffering far more than need-be.
Another review of the CDC Guidelines found a number of contradicting statements based on the presented evidence and the recommendation strength. According to the National Guideline Clearinghouse, “Level A rating requires at least two consistent Class 1 studies. However, all 12 recommendations provided are based on case series (level 3 evidence) or expert opinion (level 4 evidence) yet were assigned a Grade A recommendation. For
instance, according to the guidelines providers should implement additional precautions when increasing dosage to ≥50 morphine equivalents (MME/day, and should generally avoid increasing dosage to ≥90 MME/day (recommendation category A, evidence type: 3)”. This recommendation was based on ONE randomized un-blinded study of only 135 patients (94% male; 74% had musculoskeletal pain) who received 40 MME/day compared to 52 MME/day, yet the recommendation was generalized to “chronic non cancer pain” and the recommendation “to avoid increasing dosage to ≥90 MME/day” was not even evaluated by the referenced study.. (Really scientific, right!) We believe that increasing awareness of the opioid overdose risk is appropriate, but claiming certain unsubstantiated risks out weigh the benefits of using opioids to treat pain lacks scientific foundation. According to a recent study by Dasgupta et al, of 2,182,372 patients prescribed opioids, 478 overdose deaths were reported (0.022% per year). Based on this it is astonishing the CPSA would use the CDC Guidelines as the template for their program. It poignantly points out the lack of knowledge they have concerning this subject, and how misguided they are.
To assign a cut-off of morphine 90mg per day, is oversimplified and will create challenges in practice. The guidelines recommend a standardized MME, or a “morphine maximum dose” sometimes abbreviated MMD, but does not recommend a standardized method for calculating morphine equivalence. There is a wide variability among opioid conversions including, but not limited to online dosing calculators. Rinnick, A and others that include nationally renowned pain experts, compared equianalgesic conversion estimates as calculated by practicing clinicians, by surveying 411 healthcare professionals; 129 physicians, 213 pharmacists, and 69 nurse practitioners. After adjusting for statistical inclusion, 319 participants were incorporated in the final analysis.
Participants were asked to provide the morphine equivalent for hydrocodone 80mg, fentanyl 75mg/hour (1800mcg/day), methadone 40 mg, oxycodone 120 mg, and hydromorphone 48 mg. They were also asked to provide the resource used in their calculation. MME for fentanyl, hydrocodone, hydromorphone, methadone, and oxycodone were: 176 (±117) mg, 192 (±55) mg, 193 (±201)mg, and 173 (±39)mg, respectively. The authors stated “A total of 124 (46%) respondents identified using personal knowledge as a resource for their conversion problems, followed by use of an online calculator at 83 (31%), a textbook table at 45 (17%), and a conversion table from a journal at 15 (6%).
Considering the Rennick study, it is of particular importance that the standard deviations for fentanyl and methadone “morphine equivalents” will exceed the CDC cut-off by the CDC’s own definition of morphine equivalent. In other words, the CDC guidelines suggest patients should not receive more than a 50 MME and not to exceed 90 MME.
But, by Rennick’s findings, a calculation for fentanyl 7.5 mg patch would be up to 117 MME less than and 117 MME more than the 7.5mg (75 mcg/hour) fentanyl dose. What does that mean? Looking at this another way, one clinician’s MME in this case could be 59 MME and another clinician might assign the equivalence of 293 MME, a range spanning 234 mg of morphine equivalent. Just the standard deviation alone is a recipe for death in the untrained professional. Again, this shows the lack of knowledge the CPSA has put forward with what they are proposing.
Given the lack of standardization, potential drug interactions, a patient’s physical features such as height and weight, gender, organ function, coupled with patient individualized pharmacokinetics due to polymorphism, we respectfully disagree with utilizing a standard cut-off for morphine dose. We suggest the CPSA give credence to these mathematical and physiological variabilities and employ efforts to mandate education for providers and to approach every conversion for each individual patient slowly and carefully. Stop using the one size fits all approach as that is not correct; each person is an individual. Better still let these decisions be made between the patient and their doctor.
It is unfortunate the CPSA has chosen the path they are now on and listened solely to the anti-opioid crusaders instead of listening to people who are suffering. Those with pain are seldom asked and then actually listened to when it comes to their pain. It is unfortunate the media has exacerbated the problem with sensationalistic stories and passed on conjecture, false and semi-truthful stories. Such as 80% of heroin users started on prescription medication, when the reality is: “According to the large, annually repeated and representative National Survey on Drug Use and Health, 75 percent of all opioid misuse starts with people using medication that wasn’t prescribed for them—obtained from a friend, family member or dealer. And 90 percent of all addictions—no matter what the substance—start in the adolescent and young adult years.” Young people who misuse prescription opioids are heavy users of alcohol and other substances. This type of substance use, not medical treatment with opioids is by far the greatest risk factor for opioid addiction according to a study by Richard Miech of the University of Michigan and his colleagues. For their research they analyzed data from the nationally representative “Monitoring for the Future” survey, which includes thousands of students.
In general, new addictions are uncommon among people who take opioids for pain. Another report from a large study of emergency room visits stated that less than 5 percent of attempted suicides involved pain medication. This was from a data base of more than one billion emergency room visits from 2006 to 2013.
We believe that increasing awareness of the opioid overdose risk is certainly appropriate, but claiming unsubstantiated risks outweigh the benefits of using opioids to treat pain lacks scientific foundation. According to a recent study by Dasgupta et al., of 2,182,374 patients prescribed opioids, 478 overdose deaths were reported (0.022% per year). We firmly believe there is lack of education and training on opioid prescribing; instead of improving knowledge of healthcare professionals, this CPSA program is placing the burden on patients by reducing opioid access for patients that legitimately require them.
Also, by ignoring for years what the real problem was—ILLICIT drugs—they have compounded the problem. Although there is a huge deficit in the education provided on pain management in medical and pharmacy schools, Alberta has a number of well qualified clinicians who should be utilized in creating better educational programs in our teaching hospitals. A study done by Mezei et al., concluded that education for North American medical students is limited, variable and fragmentary. Over 80% of attending physicians rate their education on chronic pain during medical school as “inadequate”.
We believe the implementation of this CPSA program will have a drastic negative impact on patients living with pain and their loved ones. This proposed guideline will place restrictions on personalized patient care and prevent clinicians from providing high quality care. We find it quite disturbing the CPSA would move forward with their program based on the very flawed CDC Guidelines, which again are based on expert opinion, not on evidence; especially when the majority of those “experts” are strongly biased, as indicated by their affiliations to anti-opioid advocacy groups. Under this qualification it is equally disturbing they accepted the premise of the CDC Guidelines when in 2014 guidelines on the “role of opioids in the treatment of chronic pain”by the National Institutes of Health and based on an extensive literature review by an unbiased expert panel concluded: “What was particularly striking to the panel was the realization that there is insufficient evidence for every clinical decision that a provider needs to make regarding the use of opioids for chronic pain, leaving the provide to rely on his or her own clinical experience.” It was also observed the target should be what the patient and their healthcare provider have decided between themselves as a reasonable goal to accomplish. We concur with this observation the patient and their doctor should decide what works or does not. Good medicine is a science, based solely on clinical research.
Excellent medicine, on the other hand, is a scientifically informed art, understanding the uniqueness of every person and every situation, and utilizing answers to questions that science often lacks the tools to ask.
It is surprising the CPSA would not work closely with a number of physicians in this province who have worked extremely hard over the past twenty years to refine their practices and increase their knowledge of the treatment of pain. Many have furthered their education every year with some receiving the Royal College of Physicians and Surgeons specialty certification in Pain Medicine, FRCP ©. The CPSA should be following these physicians instead of reacting to a situation beyond the control of people with pain and their healthcare providers; ILLICIT SUBSTANCES, and following the path of a few academics who have an extreme bias.
It is unfortunate that the CPSA has reacted to the most recent tragedies inflicted by the use of ILLICIT FENTANYL, but if they think their program will mitigate the problem they are “dead” wrong. Indeed, as with lessons learned from the Prohibition of alcohol, the consequences are only greater harm. Restricting the legitimate use of opioids drives patients to illicit substances, which are not only potentially contaminated and of
unpredictable potency, but they also support crime. Addicts have never had their disease mitigated by the restriction of supply. Criminal suppliers always find the means to meet their demands. If the CPSA thinks the present problem with ILLICIT substances is new they are again wrong. You don’t need to look any further then the Prescription Drug Research Center to understand this has occurred regularly since fentanyl was developed in 1963 at the Janssen Research Laboratory in Belgium. Shortly after the discovery, in 1970, in California a substance being sold on the street as heroin,( called “China White”) was discovered, it was however an actual analog of fentanyl. In the intervening years, clandestinely produced fentanyl analogs have appeared in the street drug trade, with the usually predictable consequences. This has led to where we are today with even more potent illegal substances on the street, with, according to the Drug research Center worse ones on the way. But, when you don’t admit what the real problem is, or try to obfuscate it, you can’t solve it.
This proposal concerning the safe prescribing of opioids by imposing more requirements on physician prescribers is a dreadful folly. It is a disservice to people with pain, people addicted and those thrill seekers who feel they cannot be affected by trying these ILLICIT substances. If you want to reduce opioid addiction you have to target the real risk factors: child trauma, mental illness and unemployment. We should be working to create better mental health programs and then funding them adequately. Perhaps some of people on the street would not have been there if we had. Real dollars should be spent on pain research and education within our medical schools. We should work to give proper budgets to our law enforcement agencies so they may really fight the illicit smuggling. But, when you won’t admit what the real problem is you can’t solve it. We must not continue failing the citizens of this province when it comes to treating a condition that affects more people than heart disease, cancer and diabetes combined. Of course, we all want to ensure the safety of society and patients through the proper use of opioids, and try to ensure safety for those who are addicted or misusing them is laudable, but ineffect we are now punishing legitimate users of opioids. Those who are misusing are basically breaking the law, so are they more important than those who follow all the rules. We think not. One of the most important things in medicine is the trust that develops between doctor and patient; a key to getting well. The present approaches to opioid prescribing has broken this basic tenet of medicine and has undermined the trust many people with pain had with their doctor. It has had a profound negative effect on those people and is affecting their health care.