By R Carter
The CDC’s methods and methodologies are increasingly under fire with regards to it’s reporting on opiate overdose deaths and prescribing guidelines. It’s unscientific methods and disregard for federal guidelines in performing research have more watch dog groups like Washington Legal Foundation taking a swipe at their reports and policy.
In Part 1 of this series I looked at the raw sources of data for compiling statistics on prescription opiate overdose deaths. From this we see that 92 percent of the sources are either primary care providers or attending physicians who are required to fill out a death certificate within 72 hours of a person’s death. And we see that general guidelines have no requirements to ensure that a cause of death, listed as an opiate poisoning, be documented by lab tests as proof that toxic amounts were actually the cause of death.
|From the CDC Wonder Website, Mortality Data|
The mortality data are based on information from all death certificates filed in the fifty states and the District of Columbia. Deaths of nonresidents (e.g. nonresident aliens, nationals living abroad, residents of Puerto Rico, Guam, the Virgin Islands, and other territories of the U.S.) and fetal deaths are excluded. Mortality data from the death certificates are coded by the states and provided to NCHS through the Vital Statistics Cooperative Program or coded by NCHS from copies of the original death certificates provided to NCHS by the State registration offices. For more information, see Technical Appendix from Vital Statistics of United States: 1999https://wonder.cdc.gov/wonder/help/ucd.html
|Mortality Data Sources:|
The Underlying Cause of Death data are produced by the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention (CDC). Mortality information is collected by state registries and provided to the National Vital Statistics System. Underlying cause of death and demographic descriptors are indicated on the death certificates. Each death certificate contains a single underlying cause of death, up to twenty additional multiple causes, and demographic data. The underlying cause-of-death is defined by the World Health Organization (WHO) as “the disease or injury which initiated the train of events leading directly to death, or the circumstances of the accident or violence which produced the fatal injury.” Underlying cause-of-death is selected from the conditions entered by the physician on the cause of death section of the death certificate. When more than one cause or condition is entered by the physician, the underlying cause is determined by the sequence of conditions on the certificate, provisions of the International Classification of Diseases, and associated selection rules and modifications.https://wonder.cdc.gov/wonder/help/ucd.html#Source
To learn more about the methods and source of these data please reference:
- National Center for Health Statistics: (NCHS) Multiple Cause of Death data web site
- National Vital Statistics System: Mortality web site
- See also Data Source Citations
In Part 2 we going to look at how the individual certifying the death certificate uses their knowledge of medicine to make a judgement about what the cause and contributing factors are for a death. I will also look at some of the rules used for coding death certificate cause of death.
|Box 32 Part 1|
The U.S. Standard Certificate of Death Box 32, Part 1 provides spaces for the certifier to list, in the order of importance, those conditions which lead to the cause of death. They are broke down in sub-parts A, B, C and D and require a code using ICD-10 (International Classification of Disease 10th Revision) codes.
Sub-part A is the immediate cause of death or the final disease or condition resulting in death. Sub-part B-D are a sequential list of conditions or diseases contributing to the cause of death. Based on coding rules, a Sub-part D condition must lead to the cause in Sub-part C and on up the list until the immediate cause is identified. Sub-parts B-D are considered to be “Underlying Causes”, meaning they play an indirect but substantial role in contributing to a persons death, so much so that one can’t occur without the other.
For example a blood infection may attack the cardiovascular system causing a profound and prolonged drop in blood pressure and blood flow. While not being a cause of death, the loss of blood pressure leads to death of cells in the kidney, which produces kidney failure. The kidney failure is ultimately the cause of the death, but the underlying blood infection is a major contributing factor.
The example given above is a critical concept in the discussion about coding a death certificate with codes which list the cause of death as poisoning. Using a similar example as those above we can apply the same logic to a cause of death which involves opiates.
Assume a person’s death is listed as asphyxiation, but the underlying and contributing causes in Sub-parts B-D may be poisoning from Barbiturates, Alcohol and Opiates.
The actual sequences of events were consumption of Barbiturates, Alcohol and Opiates, which led to producing a profound level of sedation, not unlike an anesthetic. The body reacts to the poisons by trying to expel them from the body through vomiting. Because of the profound sedation, the individual is incapable of protecting themselves during this event and the airway becomes blocked by the contents of the stomach. This produces asphyxiation and death. In this example opiates are not “the cause” of death, but they played a major role, along with the other drugs.
It is important to note that in more than 95 percent of drug poisoning deaths, there are always multiple substances involved. No one substance is usually the cause. Drugs are synergistic, meaning they compound the effects of other drugs. This compounding phenomenon is a singular cause by itself and no one drug could have been a singular cause unless massive amounts were consumed.
More importantly, to prove a single drug as a cause, you must have toxicology data that both identifies type and quantity of the substance. Further compounding the collection of opiate deaths is the fact that in approximately 1 in 5 drug overdose deaths, no specific drug is listed on death certificates. This injects an automatic 20% error rate into the data. Also complicating the accuracy of opiate overdoses is that some synthetic opioids do not yet have designated codes which can be reported to the CDC. To overcome this short coming, state agencies often rely on data from the National Forensic Laboratory Information System which provides information on drug products obtained by law enforcement that tested positive for fentanyl, and the National Poison Data System which provides information on poison center calls regarding fentanyl overdose.
It’s for these reasons that when compiling statistics related to prescription opiate overdose deaths, the lines get blurred and ambiguous. It is this inherent ambiguity which is the Achilles heel in the CDC’s reporting. Strictly speaking though, from a morbidity and mortality point of view, opiates would have been “a data point” in the contributing cause. In practice, the entire chain of events is needed to truly understand the role opiates play in overdose deaths.
With regards to prescription opiate overdose deaths, report accuracy could be achieved by eliminating deaths which include in their chain, substances other than opiates. A rational assumption, since most doctors do not prescribe illegal substances nor do they routinely prescribe alcohol, barbiturates, benzodiazepines, cocaine, amphetamines or other psychoactive substances with opiates.
To close this gap and increase accuracy, there have been multiple studies done where a smaller sample of poisoning deaths have complete toxicological studies done to statistically identify specific samplings of prescription vs illegal opiates. Statistical variations from these studies are then applied to death data from the CDC to provide a computed value for prescribed opiate overdose deaths. See Part 3. Although encouraging in its efforts to clarify, even this effort falls short of accurately representing prescription opiates. Those who died from an overdose have still been selected based on a single data point, absent of the chain of events we know to contribute to every death. A good example of this is this report from Texas.
The real problem arises in how the CDC uses this information and reports it. Rather than expressing opiates as a contributing factor in morbidity and mortality, the CDC makes a very black and white assertion that opiates are a cause of death, sometimes based on single data point.
By singling out one data point in a sea of other contributing factors, the CDC performs a most grievous disservice to society. Splitting hairs so to speak, to forward an agenda which is likely motivated by other factors, not the least of which may be politics and ideology. Without an investigation of the process and individuals who operate in this manner, we will never know what their motivations may be.
It’s certainly within the power of the CDC to be more transparent with the public on where the data comes from and how it is used. The question becomes, why don’t they?
Other factors which raise questions about how death certificate data is compiled are based on a system the NCHS uses to capture data from Box 32 Part 1. As I mentioned in Part 1 and here, the certifier filling out the death certificate is only obligated to fill in a blank. What goes into the blank is completely dependent on the qualifications and integrity of the individual. Should that person enter information which is unclear and ambiguous, such as poisoning, the NCHS’s Automated Coding System will make an attempt to select codes it believes are most appropriate. From the CDC’s “Coding and classification of causes of death in accordance with the Tenth Revision of the International Classification of Diseases” publication we find this section which describes that process.
While the language and terminology of medicine is quite specific, it’s no guarantee that a word will be interpreted correctly. This is why each diagnosis is required to have a code from the ICD-10 Manual. Between both sources, the system should be able to make an accurate interpretation of the intent of the certifier, most of the time.
|What Are The Facts|
- Diagnosis Codes used in Box 32 Part 1 are dependent on the qualifications, intent and integrity of the certifier filling out a death certificate.
- Because one action or event can lead to another, events leading up to the cause of death are like dominoes.
- Each is a data point and each subsequent event cannot occur without the preceding event leading to a cause of death.
- The very nature of the information collected, biology and medicine, makes it problematic to report that information out of the context.
- With regards to reporting on a single data point:
- Taking a single data point out of a chain of dependent events is at best misleading and likely irresponsible and unethical.
- Such reporting is a disservice to the tax payers who pay for this effort and who expect honesty and integrity from those responsible for these duties.
- When all data points in a chain are required to produce a results, a single data point is not a reliable source of data to form a conclusion leading to prescription opiate overdose deaths. This fact alone disqualifies the single data point conclusion regarding opiate overdose deaths.
- Reporting a single data point as a singular cause when a dependent chain is required to produce an outcome, is a violation of every known, good and proper procedure for scientific research.
- Efforts to automate data collection for cause of death, through intelligent software systems, may itself, be a contributing cause for misreporting and misrepresenting facts.
- The failure of researchers who use death certificate data to divulge how they compensate for the inherent ambiguity in the data, immediately brings into question any conclusions drawn from such research.
- Good research will identify methods used to improve statistical reliability and prevent contamination of the research and therefore the conclusions drawn.
For the sake of argument. If using a single data point from a chain of dependent events were an appropriate method for identifying problems which justified a massive government regulatory effort to correct, then every data point in the chain would need to be treated with the same and equal weight or importance.
Failure to do so would allow a chain of events to resume from the remaining causes. Under this logic, the same actions and rules applied to opiates, also apply to any contributing drug, including alcohol. Yet we see no efforts to restrict, limit or regulate alcohol on the same level we see with opiates.
For this reason, I continue to believe the war on opiates is and has been an ideological war. Ignoring this logic, refusal to treat all psychoactive substances as poisons, while continuing to push a the singular cause, such as opiates, is another example of extremism and the righteous mindset of an ideological minority.
|Preview of Part 3|
In Part 3 of this series I will look how the data is weaponized to facilitate the ideological zealots. While I don’t believe the original intent was meant to be an effort that allowed weaponizing it, the inherent shortcomings in both what and how it is collected, allows this to occur.