Fentanyl analogs and opioid overdose deaths, the story mainstream media won’t cover

blaming_doctors
Share the News
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
Like

By R Carter

An alternate title for this post, suggested by another online blogger, “If it doesn’t smell it doesn’t sell.” He was, of course, implying the drama used by much of mainstream online media. But in my opinion, this reeks and I am directing that opinion at mainstream media for their failure to cover such topics.

As of 2020, there are still publications from official sources such as the DEA, CDC, NIDA, NIH, and SAMHSA  which continue to label the opioid overdose crisis as a prescription drug problem. While I agree that prescription drugs were a contributor at the beginning in 1999, efforts to limit the supply side, close loopholes in our healthcare system that encouraged abuse from within healthcare and from outside, all have had dramatic effects on reducing the availability of prescription opioids. The last number I saw said nationwide, there’s been more than a 30% reduction in prescribing. I believe that as I know more than 50 individuals who qualify for pain management but can’t receive it due to the crackdown on prescribers. Yet the overdose rate continues to climb, showing no indication that it is even leveling off. Where’s the disconnect between what our government is telling us but what dedicated information hounds like myself, continue to uncover in the literature the average person doesn’t read.

I believe there are several reasons why we’re not being told the whole story, some of it’s due to face-saving efforts from agencies which by now, know they screwed up in some capacity. Some of it is based on a financial incentive to see someone else pay for the cost of dealing with all the lost souls who fell prey to this plague. For some of our elected officials, I believe they have been as misled as much as the public has. Still, other reasons could be, because continuing to tow the line for blaming prescribing keeps some people in a job and keeps others elected to their positions. Regardless of the reasons, this post, IMHO, is a smoking gun for those who believe as I do, that the government knows more about their culpability than what they’re owning up to, and they do so by keeping everyone focused on prescribing as the cause.

Until I found the documents included in the reference section, I had a theory that was based on three unproven facts.

  1. The system we use for inputting death certificate data is antiquated, it doesn’t allow the fine-grain detail to properly reflect the drug sources in overdose deaths whether they are illegal or prescription. Also, we count each drug involved in drug poisoning as a single death when an individual can have as many as 6 drugs in their system. The CDC has made some efforts to eliminate this problem but I’m not sure how successful they’ve been. I wrote a four-part series on this subject linked here.
  2. Our current classification for opioids using ICD-10 codes makes no distinction between illegal fentanyl, its analogs, and legally prescribed fentanyl. According to the CDC, this accounts for 70% of the opioid overdose deaths that occurred in 2017, and an additional 15% could be added to this for a total of 85% if the system worked as designed. For this reason, we desperately need to stop labeling illegal fentanyl as legal when doing a headcount on the number of opioid overdose deaths from fentanyl.
  3. Labeling illegal fentanyl as prescription medication can only be deliberate for making the case against prescribing, but at great cost to those with a medical condition for which there is no better treatment.  Government agencies don’t cross-reference the data on drug-related death certificates, with PDMP data and they won’t answer the question of why this practice even exists. Most states have had PDMP program for ten years, cross-referencing drug poisoning causes with PDMP data will tell us exactly who’s abusing prescription drugs and who’s not. States continue to keep this taxpayer-funded information tightly under control. So I ask you, who’s lying to who?

The absence of these three pieces of information, all currently within reach, easily implemented at a modest cost, would give all stakeholders as well as the public, laser precision on identifying sources for opioid overdose deaths and answer the question beyond any reasonable doubt, whether it’s a prescribing problem or an illegal drug problem. Currently, the cost of fighting the drug war is more than $500 billion per year. On some level, I don’t think the DEA and DOJ want to answer this question and why? Because since the DEA was established it’s been a large cost center for the government. By labeling prescribing as the cause, they can confiscate personal wealth and turn the DEA into a revenue-generating engine for a government that spends more than it takes in. The same is true for states who want to sue pharmaceutical companies, by keeping the public believing it’s a prescribing problem.

The CDC has multiple obstacles to overcome in their efforts to be a science-based agency. For one, they’ve had their budget cut many times. For example, during an 8 year period, between 1996 to 2003 the CDC was unable to collect death certificate data from all 50 states due to budget issues. Or even now under the current administration, the CDC is not allowed to use certain words when reporting their efforts, they are vulnerable, entitlement, diversity, transgender, fetus, evidence-based and science-based. You can read more about this following this link. For a science-based organization, just how do you do your job when your primary directive is to be a political extension of the white house instead of a public health agency?

 

The facts which get reported

In this brief based on a publication from the CDC dated January 18, 2019, titled “Overdose Deaths Involving Fentanyl and Fentanyl Analogs — New York City, 2000–2017” [4]  the CDC updated the number of overdose deaths linked to illicit fentanyl and fentanyl analogous in New York. The new data is based on postmortem toxicology testing on all drug-related deaths in New York between 2000-2012, the data had just recently been reported to the CDC for this update. Although the Office of the Chief Medical Examiner conducted fentanyl testing of all overdose cases during 2000–2012, universal testing for fentanyl was suspended during late 2013 and 2016, and the proportion of deaths tested during this time frame is unknown.

However, despite inconsistent testing, in 2015 the proportion of all overdose deaths where fentanyl was detected, exceeded that during the period of known universal fentanyl testing. The New York City Department of Health and Mental Hygiene (DOHMH), based on their testing, has stated publically that the increase in fentanyl-related overdose deaths began in October 2015, contradicting the 2013 date from the CDC.

Once testing for fentanyl in New York City resumed in mid-2016, NYC had the highest rate for fentanyl detection anywhere in the US. Further complicating the CDC efforts to collect such information was because between 2000-2012 public health labs which can perform such testing had no means of transferring data to the CDC, hampered by understaffing, old technology and a lack of standards within public health for communicating such data.

The CDC also collects data from the National Forensic Laboratory Information System, a lab maintained for the Justice Department testing drugs confiscated during drug raids. The NFLIS reported a 7x increase in fentanyl seizures between 2012-2014. Given the gap in public health toxicology testing between 2013 and 2016, the date chosen by the CDC of 2013, is an educated guess but one that is reasonable under the limited conditions in which it was made. But applying this date to all of the US is undoubtedly misleading since most of the US, about 90%, wasn’t performing forensic or toxicology testing for fentanyl until after 2017.

The lack of nationwide toxicology screening is largely due to a lack of equipment, staffing, adequate training, and related budget constraints. Building a national drug policy which by 2017 was beginning to exceed $500 billion, seems like a rush to judgment when the data is limited to a dozen or so states on the east coast. Furthermore, the underlying facts if known can lead to considerably different conclusions on what led to so many opioid deaths before widespread toxicology testing was implemented. More importantly, when such facts are not reported by the national media, most Americans are left to draw their conclusions from the thirty-second sound bites on the news or by glazing over some online headlines during a lunch break.

 

The facts which are rarely reported

To the credit of the CDC, they make this statement in their report.

The increased presence of fentanyl in the illicit drug market has implications for overdose prevention efforts; however, national reporting on the presence of fentanyl in overdose deaths is limited by the lack of standardized toxicology testing for fentanyl and the inconsistent listing of fentanyl as a cause of death on death certificates, resulting in underreporting of fentanyl involvement in fatal overdoses. Nationally, reporting on drugs involved in overdose deaths relies on death certificate data; despite local efforts to improve drug reporting on death certificates, at least 15% of overdose deaths do not specify any drugs. Thus, drug-specific data continue to be underreported, making it difficult to quantify the role of fentanyl in increasing overdose death rates.

The problem is much worse than reported above. The CDC’s reporting on opioid overdose deaths relies primarily on data from death certificates, imported from States into the CDC Databases. I wrote a four-part series on how death certificate data is collected and where the flaws are that over-inflate opioid overdose deaths. CDC Wonder relies on the WHO ICD-10 classifications for diseases and deaths, including all types of poisonings. Since fentanyl is classified as a prescription drug according to WHO, when an ME/Coroner classifies a cause of death where fentanyl was detected on toxicology screening, it goes into the CDC Wonder database with a code that is listed as a prescription drug. This has been occurring since the onset of non-medical, illicit fentanyl and it’s analogs. Naturally, it inflates all reports based on this data and is the single reason why anti-opioid zealots continue to label opioid overdose deaths prescription drug deaths, when in fact, nationwide, prescribing is down more than 30% but opioid-related overdose deaths continue to set new records. This is a disparity that gets no attention by the national media and is conveniently used by government agencies like the CDC and DEA to push for tighter controls over prescription medication when the primary problem since 2013 has been illicit fentanyl. A drug not prescribed or sold through any legal means in the US yet serves as fodder in making the case against doctors and opioid manufactures.

 

Digging deeper into the real cause behind the so-called prescription drug problem

In this post, I’ll try to educate the reader on what other details are left out by the CDC as well as dig deeper into the causes behind them. By quoting government publications, the typical tale of an opioid crisis that is primarily a prescription drug problem will be less than certain.

As of 2020 with a nationwide price tag of more than $500 billion annually to taxpayers, Americans deserve the details so they can respond in an informed manner. I believe at the beginning, prescribing was a piece of the problem, but so was a system so loosely assembled and under policed, that there’s more than enough blame for everyone.

When it comes to the subject of drug use and subsequent drug abuse, Americans land all across the spectrum, from wanting to legalize everything to wanting to criminalize everything. We’ll likely never have a majority one way or the other because everyone has their drug of choice, the one they favor and discount its risks. Take for example the world’s most abused drug, alcohol. Alcohol has an average addiction rate in the US and around the world of 6.6%, while opioids have an average addiction rate of only 0.78%. Yet during the recent COVID-19 pandemic, most states who issued stay-at-home orders shutting down all but the most essential businesses, listed as essential businesses, liquor stores. The rationale behind this, to prevent overrunning hospitals with alcoholics in withdrawal. Dying from opioid abuse, even though 10x lower than alcohol, is so unacceptable that our nation will jail doctors based on a technical misstep of poor documentation, but for bartenders, liquor store owners, we’ll just look the other way. And still, no politician will give an honest answer to why the double standard exists. If everyone applied the same criteria to all addictive substances, then liquor shops like tobacco shops would have closed during the pandemic.

As the CDC reports in all their publications, illicit fentanyl has been on the rise since 2013, this is not a false statement, but it is an incomplete one. To reveal the incomplete and left out details, I will quote from a publication entitled, “Report to Congress, Needs Assessment of Forensic Laboratories and Medical Examiner/Coroner Offices”. This is an in-depth study done in 2018 and commissioned by the Department of Justice, Office of Justice Programs, National Institute of Justice. Much of the data used in the report was based on a previous study called Project FORESIGHT (2011-2012), also commissioned by the National Institute of Justice, but was targeted specifically at US forensic laboratories. Because forensic labs and public health labs face many of the same problems, findings from Project FORESIGHT were incorporated into the report to Congress in 2018.

As previously stated, most US public health labs, up until 2017, did not screen for fentanyl when performing investigations into suspected drug overdose deaths, they simply didn’t have the equipment, trained staff, and budgets to perform such tests. Most of those who did screen used an immunoassay testing strip, the same kind you can purchase at any retail pharmacy.

As the drug overdose problem grew, more of these labs had to shift their budgets and personnel to performing these types of investigations. As such, a backlog of work began growing, hampering the efforts of the Justice Department to prosecute other cases. Since this was occurring nationwide, the Justice Department commissioned a study to investigate the problems facing public health laboratories.

Prior to 2013, when the CDC states fentanyl-related deaths started increasing, 90% of US public health laboratories were not testing for fentanyl. It wasn’t until after 2019 when Congress reviewed this report that grant funding became available to upgrade and update public health laboratories. Even now in 2020, most funding comes from agencies such as the CDC to upgrade public health labs in some of the harder-hit areas of the US and the DOJ made their existing forensic facilities available to public health labs who requested it.

Keep in mind, this report to Congress wasn’t completed until 2018 using data up through 2017, this will be an important time frame in assessing the transparency of our government institutions when reporting on the actual contribution of fentanyl to the opioid crisis.

 

Some Key Findings from the report to Congress:

  • A 2017 analysis of a subset of publicly funded, accredited laboratories’ workloads and expenditures estimated that forensic laboratories nationwide would require an additional $640 million annually to reach an optimal balance of incoming laboratory requests and casework reported (workload inputs and outputs) and maintain the ideal balance of capital investments and personnel.
    • (Due to the opioid crisis, the backlog of work grew, straining public health labs to the breaking point and delaying criminal justice proceedings. Often, death certificates were completed without testing for specific drugs which caused death.)
  • An analysis of a subset of publicly funded, accredited laboratories estimated that forensic laboratory expenditures specifically as a result of the opioid crisis totaled $270 million in 2015. Laboratory expenditures for the analysis of drugs and controlled substances increased by 37% in that year, and expenditures for toxicology analysis (including antemortem and postmortem toxicology) increased by 25%, compared to typical laboratory growth in expenditures of less than 3% per year for the past decade. Between 2011 and 2017, there were substantial increases in turnaround times and backlogs for drug/ controlled substance and toxicology casework.
  • Sufficient and consistent funding and strategic planning to address medical examiner and coroner workforce and workload challenges. Variability in medical examiner and coroner resources and access to qualified medicolegal death investigation services can result in the inequitable application of death investigations.
    • (Quality control over the cause of death determinations began suffering, the data collected became insufficient to meet standards and lab employees were at risk for losing certification status required to hold their positions.)
  • Analysis of a subset of publicly funded, accredited laboratories’ data through 2017 estimated that county, city, and state laboratories nationwide would need more than 900 additional full-time employees to efficiently address current caseloads. There is a particular need to strengthen the medical examiner and coroner workforce by addressing the critical shortage of board-certified forensic pathologists (BCFPs) and by bolstering the other positions that support the BCFP workload (e.g., medicolegal death investigators, autopsy technicians, and forensic photographers). There are currently only 400-500 physicians who practice forensic pathology full time, less than half of the total estimated need of 1,100-1,200 forensic pathologists in the United States. The true number of BCFPs needed is likely much higher, due to the surge in drug overdose deaths related to the opioid crisis, as there were over 70,000 drug overdose deaths in 2017. These personnel needs include increased training, continuous education, and staffing resources.
    • (Failing to recognize and publicize that the opioid epidemic was 70% illicit fentanyl as of 2017, the government was expecting a drop in opioid overdoses due to its efforts to reduce the supply side of opioid production. They missed the boat on this issue, is it possible that fentanyl has been contributing to the problem before 2013 and it was simply overlooked because public health labs were not screening for it and were not reporting it? Common sense says this is the likely case.)
  • The physical capacity, infrastructure, and information technology for many forensic laboratories (across the US) and Medical Examiner/Coroner (ME/C) offices are already maximized to their limits and/or outdated.
  • While ME/C systems are burdened by the opioid crisis, their workload issues are compounded by inconsistent staffing and limited budgets, resources, and supplies that make it difficult to effectively and efficiently perform death investigations across all ME/C systems and jurisdiction sizes.
  • Between 2011 and 2017, there were substantial increases in turnaround times and backlogs at forensic laboratories. Based on Project FORESIGHT data, the average turnaround time for drug/controlled substance casework grew from 58 days to 79 days (36% increase), and the average 30-day backlog soared from 385 to 1,250 cases (225% increase). For toxicology analysis (excluding blood alcohol analysis), average turnaround times grew from 38 days to 65 days (73% increase) and the average 30-day backlog increased from 325 cases to 470 cases (45% increase). For postmortem toxicology analysis, the turnaround times increased from 36 days to 53 days (46% increase).
  • Access to certified reference materials to accurately identify fentanyl analogs and other novel psychoactive substances in both drug and toxicology evidence.
    • (As of 2017 there were 120 known and different fentanyl analogs trafficked across US borders. Only one of these types was tested for using immunoassay reagent strips before 2017. At present only 22 are tested for in the CDC’s Traceable Opioid Material Kitmade available on request free of charge. These 22 represent 99.5% of analogs identified by the DEA. Fentanyl Analog Screening (FAS) Kits are also available now which cover the 120 known analog types. These kits are reference materials only and don’t qualify to meet analytical standards suitable for identifying the cause of death. For that, gas chromatography or mass-spectroscopy is needed. They are designed to be an inexpensive pretest, which can justify the higher cost of mass spectroscopy when dealing with an unknown substance.)
  • Forensic laboratory analysis and screening for both drug and toxicology (antemortem and postmortem) are complicated by the continuous emergence of new drugs and drug mixtures, requiring research and implementation of new laboratory methods and testing protocols and advanced technologies and equipment.
  • Current funding levels are not commensurate with laboratory workload increases.
    • (Lab workers are understaffed and overworked, leading the lower quality and backlogs, all of which, makes the data in hand less reliable.)
  • While some regions are affected by the opioid crisis and emergence of fentanyl and related analogs, other regions face increasing trends for other controlled substances including methamphetamine, cocaine, and other stimulants.
  • Due to the opioid crisis and the emergence of fentanyl and other drug threats from novel psychoactive substances (NPS), forensic laboratories have seen tremendous increases in workloads, and autopsy totals are threatening the accreditation status of ME/C offices. The chemical structures of NPS are similar to those of known controlled substances, and NPS are being designed to stay ahead of federal and international laws that restrict the distribution and sale of specific chemicals. At the same time, the emergence of other drug threats such as synthetic cannabinoids, synthetic cathinones (designed to mimic established illicit drugs, such as cannabis, cocaine, ecstasy, and LSD)  (“bath salts”), and stimulants such as methamphetamine and cocaine, continues to affect communities as demonstrated by regional drug trends and mortality rates. The Centers for Disease Control and Prevention (CDC) reported that deaths involving psychostimulants with abuse potential, which include drugs such as methamphetamine, increased from 5% of all drug overdose deaths in 2010 to 11% in 2015, and rates of overdose deaths involving cocaine and psychostimulants increased by 52.4% and 33.3%, respectively, from 2015 to 2016.
    • (What’s not included here and is a grave oversight, for the psychostimulants mentioned, most deaths include fentanyl mixed with these substances. As such testing for mixed substances is especially difficult when there are 120 analogs to test for, greatly complicates testing and delaying the closing of death investigations. By some estimates, the illicit drug trade on average is about 3 years ahead of US efforts to thwart their efforts, leaving law enforcement and public health always guessing as to what to expect and being unprepared for it.)
  • Methamphetamine, cannabis/THC, cocaine, and heroin continue to be the most frequently identified drugs, together representing 68% of all drugs reported by U.S. forensic laboratories in 2017 to the Drug Enforcement Administration (DEA) Diversion Control Division’s National Forensic Laboratory Information System (NFLIS). Fentanyl emerged dramatically in 2014, with frequency varying by region; the Northeast and Midwest regions faced the most drastic upward trends in fentanyl reports. Forensic analysis has become more challenging due to the rise in fentanyl, fentanyl analogs, and other NPS. According to NFLIS data, only two synthetic cannabinoids and five synthetic cathinones were reported in 2009. By 2015, 84 different synthetic cannabinoids and 35 different synthetic cathinones were reported. NFLIS data demonstrate a significant increase in the number and diversity of new and emerging fentanyl-related substances observed in forensic casework between 2015 and 2016 alone. Each newly identified substance requires additional research, development, and implementation of laboratory methods, testing protocols, and advanced technologies and equipment to ensure sufficient sensitivity and specificity to detect these emerging drugs in forensic casework.
  • The CDC notes that “at autopsy, the substances tested for and the circumstances under which the toxicology tests are performed vary by jurisdiction. This variability is more likely to affect substance-specific death rates than the overall drug overdose death rate. (OMG, a fact you rarely if ever see in any of the CDC reporting and can they back this up with facts?) The percentage of drug overdose deaths for which at least one specific drug was identified as being involved varied by year, ranging from 75% to 79% from 1999 through 2013 and from 81% to 88% from 2014 through 2017.” A recent study estimated that 70,000 unintentional, opioid-related overdose deaths from 1999 through 2015 may have been missed because of incomplete reporting.
    • (My take on this admission is that because the majority of our public health labs were not testing for fentanyl before 2013, because most only used immunoassay strips that could only identify one type of fentanyl, because our vital records system could not record illicit fentanyl deaths, our government, since 2012 onward, has completely missed diagnosed the cause of the opioid crisis, laying the blame on prescribers and opioid manufactures when in fact, it was the government caught with its pants down.)
  • We (public health laboratories) do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths.
    • (With these many flaws in the system, how reliable is the data being reported to the public? Can we really be confident it’s a prescribing problem and not a failure at identifying illicit sources of unknown substances? To listen to government agencies they sound confident, but where was that confidence when reporting to Congress?)
  • In order to promote timely access to critical data, some ME/C offices issue preliminary death certificates (pending toxicology) and finalize them once further information becomes available. While presumptive testing is extremely valuable, mechanisms for issuing preliminary findings may be impacted by accreditation requirements.
    • (Some data collection takes up to a year before it is reported as a final on a death certificate.)
  • A report from the Council of Economic Advisors (CEA) suggests that accounting for indirect costs not previously considered, increases the estimate of the annual cost of the crisis by nearly 600% (higher), to a staggering $504 billion annually.
    • (If the CDC’s estimate of missing 70,000 opioid deaths between 1999-2017 because they were not testing for fentanyl or labs were underfunded in staff and technology, then an annual cost of $504 billion is a mistake any elected official would lie about to save his ass.)
  • Between 2011 and 2017, the average turnaround time for drug/controlled substance casework grew from 58 days to 79 days (36% increase), and the average 30-day backlog soared from 385 to 1,250 cases (225% increase). For toxicology analysis (excluding blood alcohol analysis), average turnaround times grew from 38 days in 2011 to 65 days in 2017 (73% increase), and the average 30-day backlog increased from 325 cases to 470 cases (45% increase) during this same timeframe. For forensic laboratories in the FORESIGHT database that performed postmortem toxicology analysis, the turnaround times increased from 36 days in 2011 to 53 days in 2017 (46% increase).
  • A survey administered by the DEA NFLIS reported the types of instrumentation used for toxicology screening and confirmation testing in 2016, as well as the types of testing by drug and drug class. While 89% of responding toxicology laboratories (including public and private laboratories) use mass spectrometry-based screening tests, more than 90% perform initial drug testing by immunoassays, which are based on drug class and may not be reactive to fentanyl-related substances, synthetic cannabinoids, or synthetic cathinones.
    • (Immunoassays or reagent test strips, the kind you can buy at any retail pharmacy, can only test for one type of fentanyl, the kind prescribed by physicians for use here in the US. At present, there are about 120 different fentanyl analogs trafficked over our borders. If public health labs have been using these types of tests for fentanyl, they have been missing about 70% of drug overdoses from at least 2014 onward, possibly before that. This is one of the reasons why the CDC believes some 70,000 opioid overdose deaths have gone undetected.)
  • (Before reading this next bullet, some explanation. Qualitative analysis means measuring the purity of a substance against a known standard. Quantitative analysis means measuring the amount of a substance dissolved in a liquid, such as blood plasma. To get both measurements requires something other than an immunoassay test, usually gas chromatography or mass spectroscopy, both of which usually cost hundreds of dollars whereas immunoassay costs pennies. This is why before 2013, most public health labs used immunoassay testing for fentanyl.)
  • Toxicology laboratories may have unique testing needs beyond standard panels, particularly when testing for nonroutine drugs and analogs. A separate survey of ME/C offices conducted by DEA NFLIS reported on the frequency of toxicology testing of specific drugs or drug classes, as well as the frequency of quantitative analysis. While over 75% of responding ME/C offices reported always testing for alcohol, amphetamines, cocaine, and opioids (other than heroin or fentanyl), only between 51% and 75% always conduct testing for heroin, fentanyl, fentanyl-related substances, and marijuana/THC. Less than 50% always test for synthetic cannabinoids and synthetic cathinones. ME/C offices most frequently conduct quantitative toxicology testing for alcohol; over 75% of responding ME/C offices always conduct this testing, while 51% to 75% of respondents always conduct quantitative testing for the overwhelming majority of other drug classes. Synthetic cannabinoids were a key drug class where 50% of respondents or less always conduct quantitative testing. Both forensic laboratories and ME/C offices may need to consider modifications to their testing strategies based on local drug trends and emerging drug threats, and consider the capabilities of available analytical instrumentation to meet both public safety and public health testing needs.

If after reading through this report to Congress, you still believe as of 2020 this is a prescribing problem, I’d like to hear your reasons why. Leave a comment and make your case.

 

Reference:

 

  •  
  •  
  •  
  •  
  •