Monday, July 24, 2023
Important Study on Masking & Evidence: Does CDC Use Junk Science to Promulgate Mask Mandates?
A trio of well-respected University of California, San Francisco (UCSF)-affiliated medical researchers recently conducted a retrospective cross-sectional study of regular weekly reports generated by the Centers for Disease Control and Prevention (CDC) known as the MMWR publication with a focus on the subject of masks covering the time period of 1978 to 2023.
This study’s main question concerns mask effectiveness. The importance of this investigation uploaded to the preprint server medRxiv should not be understated—the MMWR reports have substantial influence on American public health policy, if not beyond. While not peer reviewed, TrialSite has suggested in multiple analyses how MMWR output was exploited during the pandemic by political forces to effectuate various policies and agendas. Hence, the importance of a critical vetting of the scientific process associated with the CDCs output. The topic of concern with this latest piece concerns mask policies during COVID-19. Ultimately, 77 studies published since 2019 met the authors’ study design inclusion criteria, with 97.4% of these studies originating in the United States. Not surprisingly, observational studies without a comparator group 22/77 (28.6%) were most frequent. As was the case often with COVID-19 vaccine analysis in MMWR, community settings in this systematic analysis were most common (36/77; 45.5%). Not one randomized study was identified even though this category of study generates the strongest evidence. Of the analysis, 23/77 (29.9%) assessed mask effectiveness, with 11/77 (14.3%) being statistically significant, yet the great majority 58/77 (75.3%) stating masks as effective. Out of those, 41/58 (70.7%) used causal language. The authors found that just one mannequin study actually employed use of causal language in the appropriate manner (1.3%). 72/77 (93.5%) of the studies related to SARS-CoV-2 only, and none of these studies cited randomized data. Just one study (1/77 (1.3%) cited conflicting evidence.
The bombshell finding: “MMWR publications pertaining to masks drew positive conclusions about mask effectiveness over 75% of the time despite only 30% testing masks and <15% having statistically significant results. No studies were randomized, yet over half drew conclusions were most often unsupported by the data. Our findings raise concern about the reliability of the journal for informing health policy.”
The study makes important points that cannot be ignored, let alone discounted. While the results are not yet peer reviewed, and generally evidence needs that validation (and this is no exception), TrialSite has monitored the CDC’s use of the MMWR during the pandemic and repeatedly reported on what appeared to be successful attempts at influencing various societally important decisions without the necessary evidence. Put another way, these CDC reports appear to serve as a justification for various decisions and policies, less the sufficient evidence justifying any particular decision or policy.
For example, during November 2022, TrialSite introduced, “CDC Releases Limited Data Snapshot: White House Exploits for Sweeping Declarations of Bivalent Vaccine Booster Success.” This MMWR output was timed conveniently to coincide with a White House COVID-19 press briefing touting the success of the bivalent BA4/BA5 mRNA booster vaccines. The product had just been authorized two months previous, and uptake was slow. While the data in this MMWR had severe limitations which are explained in the TrialSite article, the White House used the data output for backing sweeping declarations of vaccine success.
The subject: masking
In this latest study, corresponding author Tracy Høeg, M.D., Ph.D. Department of Epidemiology and Biostatistics at University of California, San Francisco, (UCSF), and two colleagues, also from UCSF Alyson Haslam, Ph.D. and Vinay Prasad, M.D., MPH convey that before the COVID-19 pandemic, evidence was lacking for surgical and N95 respirator masks in the community and healthcare setting. In fact, prior to the pandemic, the CDC had never recommended mask wearing for health members of the population, which aligns with the general advisory of the Surgeon General.
Background
Yet, despite the lack of evidence Høeg and colleagues shared in the United States, “Over several weeks in March and early April 2020, a coordinated social media campaign to recommend masks began.” By April 3, 2020, the CDC then recommended that persons aged 2 years and up wear a cloth face covering in public. By July 15, then CDC director Rochelle Walensky issued the recommendation that all Americans don a mask as a means to “get the epidemic under control.”
The evidence backing this claim: a MMWR study involving two hairstylists in Missouri. Universal masking ensued by the fall of 2020—in schools and day care facilities for example per CDC recommendations. Next came the widespread mandates enacted at the state, county and school district levels for children down to the age of two. By January 2021, federal mandates led to mandates for masking on public transport.
Conclusion
Despite the overwhelming influence of the MMWR during the COVID-19 as described above, less than 20% of these weekly reports targeting masks were based on any statistical evidence of mask effectiveness. The CDC used no randomized studies while 75% of their weekly tracking output led to a favorable conclusion about the use of masks and SARS-CoV-2. As TrialSite has explained with these same reports and the COVID-19 vaccines, MMWR data output are used by health authorities and governing agencies to support and back various policy measures.
This, despite the fact that there was a complete lack of any evidence for mask effectiveness according to the authors’ study. In this important study, the trio of well-respected San Francisco-based authors point out the need for caution and output from the MMWR. Their findings lead them to observe “the journal’s lack of reliance on high-quality data and a tendency to make strong but unsupported causal conclusions about mask effectiveness.” The systematic embrace and use of subpar scientific evidence to back profound societal policies, emergency or not, must be critically vetted.
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‘Serious Doubt’ About COVID-19 Vaccine Safety After Forced Release of 15,000 Pages of Clinical Trial Data: Legal NGO
Conservative public interest advocacy group Defending the Republic (DTR) has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”
As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained—and is releasing—nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.
Since 2022, the group has been involved in litigation against the FDA relating to the production of data submitted by Moderna in support of its application to federal regulators for approval of its vaccine.
As a result, the FDA agreed to produce around 24,000 pages of the Moderna records by the end of this year, with the 15,000 pages being the first instalment.
The records, some of which relate to adverse events related to the vaccine, include important information related to the safety profile of Spikevax, which was first authorized for emergency use in the United States in December 2020 and in January 2022 received full approval for adults.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement earlier this year.
But the new data call this view into question. The advocacy group says that the tens of thousands of pages of clinical trial data released by the FDA supports the conclusion that there is “serious doubt” about both the safety of Spikevax and the FDA’s standards for approval.
Neither Moderna nor the FDA immediately responded to a request for comment.
More Details
DTR filed its FOIA lawsuit after the FDA rejected requests to produce the Moderna COVID-19 records, justifying its decision by claiming there was no pressing need for the public to review the information.
The documents obtained as part of the group’s litigation against the FDA are the first significant release of data from Moderna’s COVID-19 clinical trials.
The studies reveal the causes of deaths, serious adverse events, and instances of neurological disorders potentially associated with Spikevax.
One of the key takeaways from the documents is that many of those who died after receiving the Moderna vaccine were not given an autopsy.
“According to one study, 16 individuals died after being administered the Moderna vaccine. The study’s authors indicated that out of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown,’” DTR said in a statement.
“Yet this did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” the group added.
As an example, the group gave the case of a 56-year-old woman who experienced ‘sudden death’ 182 days after receiving the second dose of the Moderna vaccine.
“The cause of death was unknown, and no autopsy was conducted. It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” the group stated.
There were also numerous examples in the clinical trial data of participants diagnosed with post-vaccination Bell’s Palsy and Shingles, with numerous vaccinated trial participants seeing the onset of Shingles less than 10 days after getting the shot.
The studies also showed that there were a number of serious adverse events noted in the vaccinated groups, with a number of participants experiencing heart attacks, pulmonary embolisms, and spontaneous miscarriages.
Overall, the group concludes that the 15,000 pages of data create “serious doubt concerning the safety of the Moderna vaccine and the FDA’s standards and approval of the Moderna vaccine.”
The 15,000 pages or so of data released by DTR, all of which can be found here, add to the growing body of evidence suggesting that the COVID-19 vaccines may not be as safe as advertised.
FDA Ordered to Speed Up Release of COVID-19 Data
Elsewhere, a federal judge in Texas ordered the FDA to make public data it relied on to license COVID-19 vaccines at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of about 23.5 years.
In a May 9 decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the agency was ordered to produce the data on Moderna’s vaccine for adults and Pfizer’s for children about 10 times faster than the agency wanted.
“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.
The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.
The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.
“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.
The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.
FDA officials didn’t respond to a request for comment on the ruling.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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