Damaging State Legislation Regarding Opioids: The Need To Scrutinize Sources Of Inaccurate Information Provided To Lawmakers – free full-text /PMC6857667/ – Michael E Schatman and Hannah Shapiro – 2019 Nov
On January 22, 2019, a Massachusetts State Representative introduced House Bill 3656, “An Act requiring practitioners to be held responsible for patient opioid addiction”.
Section 50 of this proposed legislation reads, “A practitioner, who issues a prescription … which contains an opiate, shall be liable to the patient … for the payment of the first 90 days of in-patient hospitalization costs if the patient becomes addicted and is subsequently hospitalized”.
When asked of the source of medical information on which he based his bill, the Representative mentioned the name of a nationally known addiction psychiatrist.
Though unmentioned, this is clearly referring to our nemesis, Mr. Kolodny, who has continued using cherry-picked data from years ago to make his claims that “opioids cause addiction”.
Unfortunately, this psychiatrist, to the best of our knowledge, had no training or clinical experience in treating chronic pain, nor has he published research on the topic area.
going back to the early twentieth century, legislation limiting opioid prescription resulted in “an immediate switch of the moral imperative from patient to physician, and in fact a chilling effect on the provision of opioids for pain”, and that the “stigmatization and criminalization of opioids produced by regulations continues to interfere with the rational use of opioids for pain to this day.
Some pain management professionals have blamed the current suffering and potential suffering of chronic pain patients and those who prescribe opioids to them on the 2016 Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain.One of the most common criticisms of the Guideline pertains to its chilling effect on prescribers and appropriate use of opioid analgesia.
The CDC has recently published its “mea culpa” regarding policies and practices supposedly derived from the Guideline that have been misapplied.
The authors of this recent admission claimed that CDC made an effort to educate various stakeholders regarding appropriate implementation of its Guideline. Although they acknowledged that the document was associated with a number of unintended deleterious consequences, the authors failed to mention the potentially most damaging consequence, i.e. draconian state laws written “in the spirit” of the Guideline without adequate evidence-base.
Gilson and Rich have recently noted that state laws regarding opioid prescribing, unlike federal laws, generally fail to recognize the importance of opioid analgesia to public health.
For example, the state of Rhode Island instituted a law in 2017, limiting daily prescription of opioids for acute pain to 30 milligrams morphine equivalents (MME). Besides being arbitrary and without evidence-basis, this law fails to take into account that “a regulatory approach that takes into account prescriber intent and patient-specific factors that influence prescribing is likely more effective than a strict limitation on the amount or duration of opioid prescribing”.
No one is paying any attention to “patient-specific factors”, even those should be the most important of all.
Our medical system touts “personalized medicine” as being more effective, yet utterly fails to apply this to pain medication. As soon as opioids are involved, science and facts are disregarded and only the media-fueled anti-opioid hype is considered when making laws.
An even more disconcerting piece of legislation signed into effect is the Arizona Opioid Epidemic Act of 2018. The lengthy document begins by stating that 75% of heroin users in treatment “started with painkillers, according to a 2014 study by the Journal of the American Medical Association”.
The JAMA study to which the authors allude was actually published in JAMA Psychiatry, not JAMA. The data were collected “from third quarter 2010 to third quarter 2013”, and included only a sample of patients admitted for substance dependence/abuse treatment during that timeframe.
Consequently, the generalizability of this sample to all heroin users is questionable
Failure to recognize the dramatic change in the opioid prescribing zeitgeist between the study period and the time at which the state’s law was written essentially invalidates the claim on which it was based.
The rationale used to justify the Arizona law is rife with even more outdated and accordingly invalid data, such as its assertion that opioid prescribing rates for adolescents doubled between 1994 and 2007. In addition to the highly inaccurate premise behind the Arizona opioid law, implementation of the premise also leaves something to be desired.
For example, the law dictates a 5-day limit on initial fills of prescription opioids in cases in which the state is the payer, even though there is no empirical evidence suggesting that this approach results in greater individual or societal safety. Regarding the law’s 90 MME prescribing limit, officials in Arizona, not surprisingly, evoked the 2016 CDC Guideline.
Perhaps the most ludicrous of the recent opioid laws is that recently enacted by the state of Nevada. According to this law, any provider who prescribes a controlled substance must, “Conduct an investigation, including, without limitation, appropriate hematological and radiological studies, to determine an evidence-based diagnosis for the cause of the pain”
That is exactly what doesn’t work for so much chronic pain; the source of the pain is often unknown. But not knowing why a person hurts is NOT a reason not to treat their pain effectively.
we cannot lose sight of the reality that much of the chronic pain that we treat is maldynic in nature, i.e. “pain that persists in the absence of ongoing tissue damage or injury” and is refractory to standard treatments
Our concern with the Nevada legislation, of course, is that patients plagued with severe, intractable maldynia should not be denied access to opioid analgesia simply because radiographs and hematological evaluations are unable to pinpoint the exact cause of their pain and suffering.
The take-away message of this editorial is that legislators cannot afford to rely on
- self-proclaimed experts who have
- backgrounds in disciplines such as addiction psychiatry with
- no training, clinical experience, or even research experience in pain medicine,
nor can their constituent patients.
Pain education organizations and advocacy groups are willing to respond to legislators’ (as well as the media’s) inquiries for direction from experts who are bona fide key opinion leaders in pain medicine.
It doesn’t seem too much to ask that laws, regulations, and any restrictions should be determined by those with expertise in the field they are regulating.