Thursday, February 10, 2022

Matters of concern in the defense data dump

"Data appears to show a marked increase in 2021 in conditions that have been observed to be *side effects* of the COVID-19 vaccines"


These are dangerous times, and we are in a 21st century global information war. Cannon balls are flying, and there are false flag operations and concern trollery to the left, right and center of us. And yet onward we ride. The Light Brigade.

And then unexpectedly, onto the public stage, steps Drs. Samuel Sigoloff, Peter Chambers, and Theresa Long. Department of Defense whistleblowers who downloaded a massive trove of unclassified data (to download the Excel file see the link “Data from the Defense Medical Epidemiology Database (DMED) shows”) on the incidence of various diseases before and after the onset of illegal forced genetic COVID-19 vaccination of our military forces.

Now these are basically raw data from the Defense Medical Epidemiological Database (DMED). For the detail oriented, this is the scrubbed and de-identified (HIPAA compliant) database derived from the Defense Medical Surveillance System (DMSS), which pulls directly from patient records and other US Department of Defense-related medical record information streams. These data were pulled with full chain-of-custody documentation based on various CPT codes that are related to known genetic COVID-19 vaccine side effects.

As raw data, this information needs to be reviewed with care and considered to be both rough and preliminary. For the uninitiated, there are major risks associated with reliance on large, raw (uncorrected) data sets for retrospective (backwards in time) data analyses. The key technical term here is “confounding variables”, but data entry errors (such as multiple entries for the same diagnostic event) or process changes can also introduce huge sources of bias into large data sets like this. With raw data, it is most useful to consider any data plotting to be sort of a first draft, useful for identifying potential trends or topics that deserve more detailed analysis. But sometimes, when the observed effect size in the raw data is very large or potentially important, alarm bells start ringing even before full analysis is completed. And that seems to be the case with these data.

Nick Hudson, the Chairman of the South African PANDATA group (a leader in providing accurate data analysis throughout this pandemic), summarizes the situation like this “The DMED record data appears to show a marked increase in 2021 in conditions that have been observed to be side effects of the COVID-19 vaccines. For many of these, mechanistic explanations have been established or at least proposed. It is important to rule out distortions owing to recent changes to the system, such as increased coverage (for example, broader selections of personnel or inclusion of family members), changes in handling of multiple records from single cases, and changes in propensity to report owing to changes in policy, access to the system, participating entities or recent advisories or advertising of the system. An instructive test would be to check that we do not see a similar rise for conditions that could not plausibly exhibit a significant association with the vaccines, such as broken legs or burns. This is especially important since the total reports of diseases and injuries have apparently risen by an order of magnitude, which would suggest extremely high prevalence of adverse events among a population that is likely healthier and fitter than the general population. The data are presented in summary format. Underlying data with dates and depersonalized patient indices, together with vaccination records for the population covered by the database would likely deliver swift and incisive conclusions.”

Now for some reason, although this database has apparently been managed for years by the same NIH subcontractor, and has been included in the CDC datasets including those reviewed by the CDC’s COVID-19 Vaccine Safety Technical (VaST) Work Group, the geniuses that have been managing it have never identified any issues before the whistleblowers grabbed this download. Does not inspire confidence, no matter what the final “official” explanation becomes.

Based on this presentation dated 04 February, Slides 3 and 13 both indicate that Fauci and colleagues at the NIH are working with the DoD, and the data from the DMED database was being shared. This makes it VERY difficult to argue that Fauci did not know this data. It also makes it even harder to believe that, with all these agencies watching the same data, no one thought the historical data was incorrect until the whistleblowers sounded their alert.

Despite this, as the data entered the public sphere with the “second opinion” public Senate hearing convened by Senator Ron Johnson, the DoD saw fit to communicate with Politifact rather than the Senator, providing the following statement:

“But Peter Graves, spokesperson for the Defense Health Agency’s Armed Forces Surveillance Division, told PolitiFact by email that "in response to concerns mentioned in news reports" the division reviewed data in the DMED "and found that the data was incorrect for the years 2016-2020."

Officials compared numbers in the DMED with source data in the DMSS and found that the total number of medical diagnoses from those years "represented only a small fraction of actual medical diagnoses." The 2021 numbers, however, were up-to-date, giving the "appearance of significant increased occurrence of all medical diagnoses in 2021 because of the underreported data for 2016-2020," Graves said.

The DMED system has been taken offline to "identify and correct the root-cause of the data corruption," Graves said.”

As noted above, among the many curious aspects of this statement is that the CDC VaST has apparently been monitoring these data for years, and never identified this “data corruption” as an issue.

So, what do the original data show (prior to Defense Health Agency’s Armed Forces Surveillance Division correction of the “data corruption”)?

In reviewing these data, what we see are baseline data from 2016 to 2019 (pre SARS-CoV-2/COVID-19), 2020 (the first year of SARS-CoV-2/COVID-19 when no vaccines were available), and 2021 (the year that vaccines were available and mandated for the US Military).

As noted above, there are many potential confounding variables, but whatever the cause, if these data are not due to longstanding and previously undiscovered “data corruption”, then we have a major issue with the overall health of our armed services.

And if they are due to previously undiscovered “data corruption”, why wasn’t someone running around with their pants on fire trying to figure out what is going on here long before the whistleblowers brought this to national attention?


Covid drugs a booster for Pfizer sales

As Pfizer forecasts strong sales this year for its Covid-19 vaccine and treatment, the drugmaker is on the hunt for deals to bolster its pipeline of experimental products.

Pfizer said on Tuesday night that surging sales of its Covid-19 treatment and continued demand for its shots should boost the company’s revenue to around $US100bn ($140bn) this year. The company estimated that sales of its antiviral pill Paxlovid will reach about $US22bn while the vaccine will add $US32bn.

That is on top of last year’s sales of $US36.8bn for the vaccine, also known as Comirnaty, the highest annual sales total for any pharmaceutical product. Paxlovid sales last year totalled $US76m.

The company has done a handful of recent acquisitions and partnerships to bolster its pipeline of drugs and vaccines, including several partnerships announced last month to boost its growing mRNA business. In December, Pfizer said it would acquire Arena Pharmaceuticals for $US6.7bn. Pfizer says it has invested $US25bn on business development since 2019.

With a growing chest of cash, Pfizer says its deal-making strategy will focus on drugs in early and late-stage development in areas the company is already focusing on, such as oncology, immunology and rare diseases. The New York-based drugmaker forecasts new deals to generate $US25bn in additional revenue by 2030. “We would like to deploy capital in scientific areas that we have expertise in so we can choose the right targets,” chief executive Albert Bourla said in an interview.

The prospect of further deal making could address concerns from analysts and investors who are watching what Pfizer does with its windfall from the pandemic. Sales from the pandemic vaccine and treatment will taper over time and the company faces drops in sales as innovative products lose their patent protection. Pfizer shares had fallen more than 4 per cent on Tuesday night following its earnings. The drop was because investors were expecting Pfizer’s guidance on this year’s earnings per share to be higher than $US6.35 to $US6.55, according to Evercore ISI analyst Umer Raffat.

“It’s our all-time record high,” chief financial officer Frank D’Amelio said, regarding the company’s guidance. He said analysts may have had higher expectations because of the pandemic products, but noted that Pfizer’s estimates only include finalised agreements.

Pfizer is in discussions with more than 100 countries for Paxlovid, so revenues are likely to come in higher than the $US22bn should it strike more agreements.

To fight Omicron surges, some countries are handing out second booster shots. In Israel, early data suggest a…
Paxlovid is cleared for use in people in the US 12 years and older who are at high risk of developing severe disease. The company said it expects to begin a study of the drug for children 6 years to 18 by the end of March. Results from studies of the drug in adults who are at standard risk for severe disease and household exposure should come later this year, Pfizer said.

The drug remains in short supply, and has been difficult to find in the US as Pfizer increases production to 120 million courses of treatment this year.

While Pfizer says Paxlovid works safely, and was effective against the Omicron variant in laboratory studies, it says it is working on a new treatment, too. The potential drug is designed to counter possible viral resistance to Paxlovid, require fewer pills in a course, and to work without the aid of the antiviral ritonavir that is given with Paxlovid, but carries safety risks for patients taking some common medications, according to Pfizer.

“We are not taking any chances; we’re going to stay on the forefront of the scientific efforts to battle the pandemic,” said Mr Bourla.

The company says it will begin studying the new Covid-19 treatment in the second half of this year.

While Pfizer says demand for the vaccine may wane, it expects growing demand for the treatment. Yet sales of both will combine for more than half of annual $US98bn to $US102bn Pfizer forecasted revenue for 2022. Pfizer says the virus won’t be fully eradicated in the near term because it is difficult to contain, has been shown to mutate, and that data shows natural infections don’t lead to long-term protection needed to prevent transmission and mutations.

The Covid-19 vaccine from Pfizer and partner BioNTech SE has grown into one of the most widely used shots globally. Pfizer’s booster shots have also seen the greatest use in the U.S. Nearly 50 million have been administered.

In the last three months of 2021, Pfizer’s vaccine achieved $US12.5bn in sales, contributing to overall revenue of $US23.84bn. A year earlier, Pfizer’s fourth-quarter revenue was $US11.63bn.

Adjusted earnings grew to $US1.08 a share, from 43c a share in the year-ago quarter. Analysts polled by FactSet had forecast adjusted earnings of 87c a share on sales of $US24.16bn.




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