By Erik Sass

 

Combating any disease requires accurate and consistent epidemiologic data to guide the public health and medical community. For most conditions affecting Americans – heart disease, cancer, diabetes, HIV, hepatitis, infant and maternal mortality – we carefully measure case rates, hospitalizations, deaths, and disease trends to guide clinical and public health action. Collecting accurate data is the foundation for an effective health care response. 

 

COVID-19 should be no different. We need reliable data on who is infected, who is getting sick, who is spreading the disease, and who is dying in order to stop transmission and end the pandemic. Consistent, accurate data for COVID-19 also helps us improve our response to future outbreaks of highly infectious diseases. Throughout the pandemic, data collection and reporting led by our federal health agencies has been difficult to understand and in some cases has sowed confusion among health care professionals and the public.

 

Most puzzling of all are repeated decisions by the Centers for Disease Control (CDC) to collect less data, justified by the bizarre claim that reducing the amount of data gathered will in some way improve our understanding of the disease. The negative impact of these changing data collection practices has been two-fold. During the first phase of the pandemic, they inflated COVID-19 mortality figures, with no way to go back and analyze them later. Now, amid the campaign for mass vaccination, they are doing the opposite by suppressing mortality figures for vaccinated individuals.

 

 

Counting COVID Deaths

 

When the pandemic began, the CDC had to provide guidance on what would constitute a COVID-19 death. The guidance would set the stage not only for counting cases and deaths, but also for how hospitals would charge for services and how federal and state authorities would direct resources to hospitals (funding, ventilators, PPE, additional beds). To this end, CDC issued guidance entitled “ New ICD code introduced for COVID-19 deaths” on March 24, 2020 via the National Center for Health Statistics, stating the following:

 

Will COVID-19 be the underlying cause?

The underlying cause depends upon what and where conditions are reported on the death certificate. However, the rules for coding and selection of the underlying cause of death are expected to result in COVID19 being the underlying cause more often than not.

 

What happens if certifiers report terms other than the suggested terms?

If a death certificate reports coronavirus without identifying a specific strain or explicitly specifying that it is not COVID-19, NCHS will ask the states to follow up to verify whether or not the coronavirus was COVID-19. As long as the phrase used indicates the 2019 coronavirus strain, NCHS expects to assign the new code. However, it is preferable and more straightforward for certifiers to use the standard terminology (COVID-19).

 

What happens if the terms reported on the death certificate indicate uncertainty?

If the death certificate reports terms such as “probable COVID-19” or “likely COVID-19,” these terms would be assigned the new ICD code. It is not likely that NCHS will follow up on these cases.

 

Should “COVID-19” be reported on the death certificate only with a confirmed test? COVID-19 should be reported on the death certificate for all decedents where the disease caused or is assumed to have caused or contributed to death.

 

Clearly the CDC was interested in capturing all patients dying with and because of COVID-19. But this highly inclusive approach to counting COVID-19 deaths resulted in confusion about whether COVID-19 was actually the cause of death. For example, a hospice patient with cancer who was diagnosed with COVID-19 became a COVID-19 death. The actual cause of death would not be revisited based on the March 2020 CDC document. This likely led to an inflated number of COVID-19 deaths reported by CDC and distrust in the approach to counting. 

 

In April of 2021, the CDC published an analysis of its data, affirming “the accuracy of COVID-19 mortality surveillance in the United States using official death certificates.” Yet the agency reiterates that the data collected is based on “suboptimal” documentation that requires further review:

 

The findings in this report are subject to at least two limitations. First, the accuracy of documentation of chain-of-event and significant contributing conditions on death certificates is known to be suboptimal; the effect of COVID-19 on completion of death certificates merits further study, with an emphasis on variation by time, jurisdiction in which the death occurred, age group, race, ethnicity, and setting of death. Second, CDC was unable to compare death certificate data with decedent’s medical records or autopsy reports for end-of-life events and co-occurring diagnoses. Medical record review is needed to confirm findings from this study and elucidate more information for decedents with only COVID-19 listed on their death certificate or those that could not be plausibly categorized as attributable to COVID-19 based on death certificate data alone.

 

An alternative approach at the outset of the pandemic might have been to require two codes to count COVID-19 deaths, as has been employed in other countries: one that represented the virus as the known cause of death, and another that allowed it as a secondary diagnosis. Collecting more data would have been helpful for understanding the full nature of the virus on diverse patient populations. But as the CDC declined to issue separate codes, making it impossible to revisit these cases for more precise analysis.

 

In fact, the trend seems to be going the other way, towards gathering less data. On May 16, 2021, Director Rochelle Walensky on CNN reported that CDC would be changing course on data collection in post-vaccinated patients. A patient dying with (rather than from) COVID-19 will no longer be counted as a COVID-19 death. Walensky presented this change as a means for more precise counting. It has the practical effect of clouding the data before and after vaccines were administered, and it could potentially minimize the impact of COVID-19 on the vaccinated population.

 

 

“Breakthrough cases”

 

As the number of individuals who were vaccinated increased in spring 2021, CDC made changes to its data collection methods. On April 30, the CDC announced that testing labs should use a polymerase chain reaction (PCR) cycle threshold of 28 or less to determine a COVID-19 case. No cycle threshold had previously been suggested, and in the absence of guidance many labs used thresholds as high as 35-40, likely producing false positives.

 

Notwithstanding growing questions about PCR efficacy in reporting a true positive case, what is certain is that based on this change the CDC will be able to report fewer cases in individuals who have been vaccinated than they would have under previous reporting standards. The shift affects our ability to interpret data trends over time and will ultimately present researchers, policymakers and the public with a picture of falling COVID-19 infections – ostensibly due to vaccine success. The new guidelines will also limit knowledge of an individual’s potential to transmit the virus after vaccination. 

 

Another move to reduce the amount of data collected was announced on May 1, 2021 when CDC announced it would no longer consider non-hospitalized “breakthrough” cases of COVID-19 in post-vaccinated patients. Again, the CDC statement claimed that collecting less data would improve overall data quality. Symptomatic cases, confirmed by a positive PCR test, occurring in an individual who has already been vaccinated would no longer be counted unless the patient is hospitalized or dies. Cases of serious illness or mortality post-vaccine may certainly be more clinically relevant, but other valuable information can be gleaned from tracking cases in patients who become symptomatic post-vaccination.

 

One key question is whether those individuals are also able to transmit the virus. If a person who has received a vaccine is symptomatic and PCR positive for COVID-19, it seems important know if they are shedding virus and might therefore be contagious. Vaccine efficacy needs to include information not only about whether it prevents serious illness and death, but also how well it prevents future infection and transmission. The new CDC guidance severely limits the ability to assess the full measure of vaccine benefits.

 

 

Vaccine Event Reporting

 

The Vaccine Adverse Event Reporting System (VAERS) housed by CDC is the system that captures reports of potential harm from any vaccines. The agency states on its website that reports “may include incomplete, inaccurate, coincidental and unverified information,” as anyone can submit a report to the database without proof or verification. This means that some reports of deaths or injuries following vaccination may be unrelated to vaccination or even fabricated.

 

On May 27, 2021, CDC specifically addressed concerns about thousands of COVID-19 vaccine-related deaths in VAERS:

 

Over 285 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through May 24, 2021. During this time, VAERS received 4,863 reports of death (0.0017%) among people who received a COVID-19 vaccine. CDC and FDA physicians review each case report of death as soon as notified and CDC requests medical records to further assess reports. A review of available clinical information, including death certificates, autopsy, and medical records has not established a causal link to COVID-19 vaccines.

 

Data collection systems are only as good as the data provided for collection. The concern about overreporting must also be considered in light of the possibility of underreporting. In fact, the historical evidence regarding previous VAERS reports for other vaccines suggests this is more likely the case. A 2010 study by Harvard Pilgrim, found that “fewer than 1% of vaccine adverse events are reported” to VAERS, a figure echoed by a 2015 study published in the scientific journal Vaccine. These studies in turn confirm the results of a previous CDC study looking at VAERS reports from 1991-2001.

 

In light of these findings, the suggestion that current VAERS death reports related to COVID-19 vaccines are likely overstated must be viewed in the context of other possible refuting information, including a high proportion of adverse events reported within two weeks of vaccination. It’s especially important to understand adverse events in the 12-15-year-old cohort, who are at extremely low risk for mortality from COVID-19. Underreporting of post-vaccine morbidity and mortality for individuals in this age group may cause us to overlook risks associated with vaccination.  

 

Successful vaccination programs have clearly driven down rates of COVID-19transmission and will hopefully continue to do so. However, changing data-gathering practices within CDC has the potential to exaggerate vaccine efficacy and minimize harmful side effects. Growing public skepticism about CDC figures can only serve to create more vaccine hesitancy and diminish Americans’ responsiveness to important public health messages.

 

 

The count, human psychology and government response

 

Gathering and disseminating accurate, meaningful data is a central pillar of effective public health response, the foundation on which every other aspect of pandemic management rests. By repeatedly reducing the amount of data gathered – about COVID-19mortality and post-vaccine sickness – the CDC seems to be working towards the opposite goal.

 

Overcounting deaths from COVID-19 led to tremendous fear and was a significant driver in the decision to shut down the American economy and massively disrupted society. These imprecise data were used to justify the U.S. government’s vaccine-only strategy, when public health authorities should have also been studying repurposed drugs for early treatment as well as other new therapies. 

 

Now, over a year into the pandemic, a new data standard from CDC – once again reducing the amount of data gathered – will encourage the public to believe that we are winning against the virus and that vaccines are the cause. That may be the case, but we still need more data on the role of natural immunity and the long-term effects of vaccine safety and their efficacy against variants. Switching from overcounting to undercounting cases won’t help us understand this complex disease.

 

A common thread runs through these questionable decisions: The CDC, an organization tasked with gathering data about public health, has instead consistently moved to reduce the amount of information it gathers. The long-term ramifications go beyond COVID-19. As the American people lose confidence in CDC’s credibility they may resist wanting to make the investments in research and public health response America needs. They may also not take the public health actions that will protect themselves and their fellow man. The CDC must restore its reputation to be an effective steward of public health. Collecting data honestly and consistently is the first step to gaining back America’s trust.  

 


Erik Sass is Editor-in-Chief of The Economic Standard.