How CDC Duped the Nation: With Artificially Inflated Data – Part I
When the Centers for Disease Control & Prevention (CDC) began discussing development of the Guideline for Prescribing Opioids for Chronic Pain [1] back in 2012, the “opioid crisis” was not even a blip on the radar but the crisis has been covered rather rigorously in the media since the development of the guideline as well as other initiatives. Much of the coverage that has followed has conflated patients in pain with having a use disorder i.e. addiction, while many other articles are simply based on false information. Why do I say that? Well, we will talk more about that but this guideline was the impetus for many patients being force tapered off of medications which were keeping them stable and productive, and in many cases, alive.
Even though the guideline is not “prescriptive”, and is ostensibly “voluntary” for physicians, and any changes in care or treatment were supposed to be decided by physicians and their patients, patients have continued to be force tapered off of their medications even when it’s medically unsafe to do so. The guideline was also supposed to exempt palliative and hospice care patients but even these patients have been left to deal with the aftermath of forced taper in some cases.
The guideline was supposedly really only meant for voluntary use and application by primary care physicians, so it makes even less sense why so many pain management specialists have been force tapering their patients off of medications that were keeping them stable and functional, there is a very logical reason for that which I will detail later but it may not be for the reason you think.
The CDC Guideline was the result of an initiative called for by the Institute of Medicine (IOM) now known as the National Academy of Medicine (NAM) back in 2011 with the report “Living Well with Chronic Illness: A Call for Public Health Action” [2] The report was released in 2012 and the recommendations contained in this report were the genesis of the CDC guideline. The guideline is loosely part of the Healthy People initiative driven by the Office of Disease Prevention & Health Promotion (ODPHP). Healthy People is a sweeping national health initiative with many other initiatives hierarchically structured beneath it which I will discuss at length in the future. It’s of import to note that other guidelines may be underway for other common conditions by the CDC based on recommendations proposed by the IOM committee:
“The committee recommends that the federal health and related agencies that create and promulgate guidelines for general and community and clinical preventive services evaluate the effectiveness of these services for persons with chronic illness and specifically catalog and disseminate these guidelines to the public health and health care organizations that implement them.” [2]
The purpose of the guideline was ostensibly to help combat the “opioid crisis” and the CDC is also a stakeholder in other important and meddlesome federal initiatives however, if you look a little deeper into the statistics that the CDC makes available for overdoses and which the media cites as gospel, it’s clear that many of these overdose deaths were the result of polypharmacy and illicit fentanyl among other illicit or illicitly obtained substances. Polypharmacy is “the simultaneous use of multiple drugs to treat a single ailment or condition” and also applies to recreational users.
We have all seen the provocative headlines that repeatedly claim that the “opioid crisis” is a “prescription opioid crisis” and an “addiction crisis”, however; this claim has not been backed up with adequate evidence. It’s important to note that co-occurring addiction in the chronic pain patient demographic is incredibly low, “less than 1% of chronic pain patients without a history of substance abuse problems became addicted to opioids during treatment.” [3] It’s important to realize that most patients in severe debilitating pain are not likely to divert their legally obtained medications because they need them to perform simple daily tasks that most Americans take for granted, it’s that simple.
It absolutely amazes me how much we talk about opioid prescriptions as if they were some terrible blight with almost no benefit whatsoever in the public discourse without ever mentioning the explosion in disease that got us to a point where painful chronic disease has become commonplace. The potential for serious injury has also increased over the last century, and with it, the potential to develop chronic or intractable pain.
It’s often claimed that opioids were being handed out like candy by physicians before the “opioid crisis” hit in earnest but this is not true aside from a few pill mills that were shut down long before the overdose rates began to climb so high. Most patients would not receive an opioid for pain unless in the case of trauma or surgery. Those with chronic pain had to try a long list of conservative treatments before an opioid would even be considered and this was before the idea of the “opioid crisis” was plastered in the news media every day and before the guideline was created. Further, as Dr. Thomas Kline points out, the incidence rate for what he calls type 2 addiction has not changed since we began tracking the statistic in the 1920’s [4] despite increased “exposure” to opioids in the general population due to both an increase in population and as a result of the campaign to treat pain more aggressively (e.g. pain as the fifth vital sign). It’s possible that genes play a role in the development of what Dr. Kline calls “type 2 addiction”:
“The Theory of “substance exposure” rests on the assumption that if you spread enough substance around the addiction rates will increase, and people will die as a result. This is correct for what we call the Type 1 addiction group: cocaine, marijuana, amphetamines and most overuse of alcohol. This is not correct for Type 2 addiction, the opiate or heroin addiction which is multiple genetic errors in gene A118G which controls the mu receptor in the brain, peripheral nerves, and in inflammatory tissue.” [4]
It’s important to realize that addiction happens independent of substances that have potential to be abused, someone either has it or doesn’t and considering that exposure rates had increased between the 20th and 21st centuries, if the exposure premise was true, we would have been more likely to see an absolute explosion in incidence rates, but we haven’t, instead, around the year 2001 when illicit fentanyl began flooding over our borders, we began to see a slow but steady increase in overdoses which appears to have hit a crescendo around 2015. Problem is, without proper data, we have no idea how many people have actually died from overdose, nor what substance(s) were the main catalyst to death. We do know that polypharmacy is a big problem among both recreational and addicted users who have died, but what appears to be pretty clear on the surface is that prescription opioids which are obtained and used legally by patients with severe pain are not the driver of the overdose crisis. If they were, after all of the extra controls that have been put in place from forced tapering, to supply chain disruptions by DEA, to prison terms for physicians, it’s likely there would not be an expected increase in overdoses into 2025 [5]; but with CDC’s conception of how it should compile data, maybe it’s no wonder it’s expected to rise.
It’s of import to note that the CDC does appear to count overdose deaths repeatedly [6] based on the number of substances that are found in decedents at autopsy via toxicology reports: “Deaths involving more than one drug (e.g., a death involving both heroin and cocaine) were counted in all relevant drug categories (e.g., the same death was included in counts of heroin deaths and in counts of cocaine deaths).” The CDC also says “Drug overdose deaths may involve multiple drugs; therefore, a single death might be included in more than one category when describing the number of drug overdose deaths involving specific drugs.” [7]
The average number of substances found in a decedent’s system at autopsy is six substances [8] for overdose victims which means that one decedent is counted as a death on average, six times (or as many times as there are substances present). It’s also possible that the CDC is counting illicit fentanyl and heroin as a “prescription opioid” even though heroin and illicit fentanyl and its analogues are never prescribed by a physician. How else might the statistics be inflated? Since one of the metabolites of heroin is morphine, some of these deaths may be counted as morphine overdoses instead of counting the actual substance that was most likely the catalyst to death: “because heroin and morphine are metabolized similarly, some heroin deaths might have been misclassified as morphine deaths”. Another example they cite: “a death that involved both heroin and fentanyl would be included in both the number of drug overdose deaths involving heroin and the number of drug overdose deaths involving synthetic opioids other than methadone.” [7]
Another concern is that CDC researchers came forward recently and claimed that overdose statistics were significantly inflated:
“In an article in the April 2018 issue of the American Journal of Public Health, four researchers at the Centers for Disease Control and Prevention’s Division of Unintentional Injury Prevention report that the CDC’s methods for tracking opioid overdose deaths have over-estimated the number of those deaths due to prescription opioids, as opposed to heroin, illicitly manufactured fentanyl, and other illicit variants of fentanyl. They called the prescription opioid overdose rate “significantly inflated.” [9]
The CDC appears to require some remedial steps in relation to gathering and compiling their data and has begun work on “improving the quality and timeliness of data on drug overdose deaths” which is a project underway at the CDC that was undertaken in August 2017, after the guideline’s implementation and before these researchers admitted that the data may be “significantly inflated”. This project is part of their State Unintentional Overdose Reporting System or SUDORS database. The purpose of this database, at least since 2017, is “to collect information on all substances that contributed to death as well as “all substances for which the decedent tested positive”. [10]
You would think that the CDC would have already been engaging in collecting data on all substances that contributed to death as well as all substances for which the decedent tested positive, especially considering that they are counting one decedent more than once in many cases, and you’d also think that they would have parsed those substances appropriately and made it clear in any statistical graphs that decedents were counted more than once, but it’s difficult to say what the status quo was before this effort without more visibility, it could be even worse than the above; if that is even possible. The federal government appears to want to track “social determinants of health”, but what about simply providing some accurate statistics on overdose rates and mastering that first? We are approaching this problem in a completely illogical way for more reasons than the above.
Considering that many public health policies, laws, initiatives, strategies and media coverage which affect patient lives are based on this data, it would have made sense to make sure the statistics were sound before possibly millions of very sick and injured patients were forced to suffer needlessly due to forced taper via implementation of the guideline as well as development of many other initiatives and interventions. It also seems logical to assume that maybe these remedial steps should have been taken long before a fear campaign in the national media was initiated in regard to the involvement of opioids in overdose deaths and before a guideline for prescribing was published and then forced onto physicians via attrition by the Drug Enforcement Agency (DEA) and the Department of Justice (DOJ) among others. It also seems logical that maybe some external, competent stakeholder(s) should be called in to ensure accuracy.
The CDC claims the guideline was “misapplied” yet their communique on its “misapplication” did not come until years after the guideline’s implementation and many patients have died, many more suffer needlessly and more will continue to die and physicians continue to force taper patients against their better judgement because they are facing “corrective” action by the federal government if they continue prescribing based on arbitrary dosing caps that have no basis in reality or any current scientific understanding. I will detail more on that later but there are also many other initiatives which have been developed and implemented over the last decade that I will dig into in detail in future articles as well.
Based on the above information, the Centers for Disease Control and Prevention have demonstrated that they are less than competent in regard to both data collection and compilation and we will discuss other very important shortcomings on the part of CDC and other federal agencies in future installments.
It seems like common sense to begin asking some difficult questions at this point in the history of the crisis as a new crisis has emerged. A crisis where patients, both acute and chronic/intractable pain patients are being left to suffer needlessly, and some have even committed suicide while others have died from complications of intractable pain disease; ostensibly based on others’ illicit use of mostly illicit substances. The “opioid crisis” is being “fought” with billions in tax payer dollars and it may be time to start scrutinizing where this money is going as overdose rates are expected to rise despite the extremely heavy-handed approach we’ve seen in the United States since the CDC Guideline was published, and despite all of the feel good interventions that are being forced on patients that sound good on paper but which anecdotal evidence suggest are catastrophic for human health.
If “social determinants” are so important to health, then why are we not looking at the guideline as a determinant of adverse outcomes? Maybe it’s time we begin taking a look at the mountain of anecdotal evidence, as “weak” as this form of evidence may be. At what point does it become a responsibility to investigate patient and physician claims? How many have to die or suffer needlessly before this happens?
There are other reasons why we should be asking questions which I will detail in depth in Part II of this exposé but one thing is clear to physicians, patients and their families, the overdose crisis has been mismanaged since the start and continues to be with impunity and no one is better off for it.
Special thanks to Dr. Thomas Kline, Dr. Jeffrey Singer, Dr. Michael Schatman and Jeffrey Fudin for all of their hard work and support for patients, the patient community, as well as others who wish to remain anonymous; (you know who you are!) thank you all for your contributions, support and guidance.
References:
[1] CDC Guideline for Prescribing Opioids for Chronic Pain: https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
[2] Living Well with Chronic Illness: A Call for Public Health Action: https://www.nap.edu/catalog/13272/living-well-with-chronic-illness-a-call-for-public-health
[3] Cochrane Opioids for long-term treatment of noncancer pain: https://www.cochrane.org/CD006605/SYMPT_opioids-long-term-treatment-noncancer-pain
[4} Opioid Addiction, is it rare? https://medium.com/@ThomasKlineMD/opioid-addiction-is-it-rare-or-not-abaa3722714 Thomas Kline MD, PhD
[5] Prevention of Prescription Opioid Misuse and Projected Overdose Deaths in the United States: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723405 Qiushi Chen, PhD; Marc R. Larochelle, MD, MPH; Davis T. Weaver, BS, et al
[6] National Vital Statistics Reports Volume 67, Number 9: https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_09-508.pdf
[7] Provisional Drug Overdose Death Counts: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
[8] Pain management, prescription opioid mortality, and the CDC: is the devil in the data? https://www.dovepress.com/pain-management-prescription-opioid-mortality-and-the-cdc-is-the-devil-peer-reviewed-article-JPR Michael E Schatman, PhD, CPE; Stephen J Ziegler, PhD, JD
[9] CDC Researchers State Overdose Death Rates From Prescription Opioids Are Inaccurately High: https://www.cato.org/blog/cdc-researchers-state-overdose-death-rates-prescription-opioids-are-inaccurately-high Jeffrey A. Singer, MD
[10] Separating Prescription From Illicit Fentanyl: https://www.pharmacytimes.com/contributor/jeffrey-fudin/2018/10/separating-prescription-from-illicit-fentanyl Jeffrey Fudin, PharmD, DAIPM, FCCP, FASHP
Dez Nelson is the Founder and Administrator for the National Advocacy Access Clinic (NAAC), a national advocacy project that aims to help restore, protect and defend medical choice and patient centered care via education, training and advocacy, and to accurately record the crisis in delivery of care which is unfolding in the United States. You can follow Dez Nelson on Twitter here or you can visit NAAC here.
© National Advocacy Access Clinic (2016- 2020) All rights reserved. Content does not constitute a medical consultation or legal advice. Please see a certified medical professional for medical advice or consult an attorney for legal advice.
📝 Read this story later in Journal.
🌎 Wake up every Sunday morning to the week’s most noteworthy stories in Society waiting in your inbox. Read the Noteworthy in Society newsletter.
How CDC Duped the Nation: With Artificially Inflated Data – Part I
Research & References of How CDC Duped the Nation: With Artificially Inflated Data – Part I|A&C Accounting And Tax Services
Source
0 Comments