Gold Standard, Anyone?

For decades, randomized controlled trials (RCTs) have provided “gold standard” evidence for medical care and advice. Unlike observational studies, RCTs compare specified groups of randomly assigned study subjects who receive either the treatment being tested or an inert placebo. Differences between the two groups, if the study is well designed, can provide reliable information about the effects of the treatment.

Authors of RCTs are supposed to publish the purpose for the trial and the test methods on ClinicalTrials.gov or similar registry before engaging in the study. Changes in protocol are a signal that the researchers may have selected data that supports their desired outcome. Pre-registry does not, however, prevent data manipulation and outright fraud.

Still, RCTs are the best method we have for evaluating a hypothesis. So, I was stunned to hear Rochelle Walensky, Director of the US Center for Disease Control (CDC), tell Congress members at a February 8, 2023, hearing on the response to Covid-19 that a weakness of the 2023 Cochrane review¹ on masks was it “only includes randomized controlled trials…” (01:09:13) and she saw no reason to conduct RCTs on mask use because so many studies (of undefined quality) showed they worked (03.39.56).²

Dr. Tom Jefferson, epidemiologist and lead author of the Cochrane review, disagrees. He began studying influenza and respiratory viruses in 1984. Shortly after the 2023 update of the Cochrane review on the use of physical interventions (i.e., face masks, isolation, physical distance, handwashing, gargling) to prevent the spread of respiratory viruses, Dr. Jefferson gave some interviews.

In an interview³ with Dr. Carl Heneghan, Oxford Professor of Evidence-Based Medicine, Jefferson explained the history behind the 2023 review:

“…a Cochrane review is a study which synthesizes all available studies—all that we can find or identify—on a particular topic. It follows a highly structured format and is always preceded by publication of a protocol. All this is to minimize the bias. Also, it is extensively transparent….the protocol was first published in 2006 and then the first version was published in 2007, updated in 2009, 2010, 2011, and then 2020, so this 2023 is the fifth update of this review.”

While the original review used randomized and non-randomized evidence, by 2020, 67 RCTs had been published. Jefferson said, “…so, we decided there was no point in looking at low quality evidence which was difficult to interpret and no conclusions could be drawn from, if we had this massive wealth of trials. So in 2020 we went forward only with randomized control trials, and we had 67. We’ve since added another 11, so we’ve got 78 in this update.”  The entire review reflects data from 610,872 participants.

Twelve of the RCTs looked at the use of medical and surgical masks to reduce transmission. Six of those studies reported laboratory-confirmed influenza or SARS-CoV-2 in their outcomes. These six studies with nearly 14,000 participants found a relative risk of 1.01 and moderate certainty evidence—“right on the line of no effect,” says Heneghan.

Jefferson concurs: “…there doesn’t appear to be any convincing evidence that masks make any difference to transmission. They may do, but the evidence is not present from trials at present.”

In commenting on the effectiveness of wearing masks outdoors, Dr. Heneghan pointed out that we may never get high quality evidence “because you’re relying on things like adherence, which reflects the real world and not the quality of the outcome….you may never get beyond moderate quality evidence and this is as good as it gets….” 

Jefferson agreed and also commented that the mode of viral transmission varies: “…the evidence is complex, it goes back 100 years, it’s sometimes contradictory, and the transmission is probably situational.”  While face masks may be useful at times, no government agencies in the UK conducted a single RCT to evaluate the use of masks in a specific community setting. But then, neither did the CDC.

Tom Jefferson was also interviewed by Paul D. Thacker, the investigative journalist who wrote the BMJ story about data integrity issues in Pfizer’s Covid vaccine trials.⁴  Jefferson told Thacker:

“Either masks don’t work, or that they may work in specific settings when packaged with other nonpharmaceutical interventions. But this has not really been looked at in a detailed way.

“The pandemic kind of threw evidence-based medicine and Cochrane out the window. Nobody seemed to care anymore about studies unless the results showed what they wanted to believe.

“Suddenly, people who liked the way Cochrane went about doing things, didn’t like Cochrane because the results didn’t favor what they wanted—masks is the most obvious here. And we see people start to change the rules, and come up with studies that could get them the right results.”

Instead of the gold standard, CDC and other government agencies have resorted to censorship, personal attacks, and unfounded certainty—as Walensky demonstrated in the recent hearing—to support their decisions. Jefferson said, these ‘experts’  “have all this certainty and think they can see the future. They’re not scientists because uncertainty is the engine of science. And they don’t have the science to back up what they claim.”

He would like to see well-designed RCTs conducted by independent researchers “…because the government has a massive conflict of interest in finding results that align with their policies.”⁵

A New Generation of Dental Appliance

Customized, removable dental devices to align teeth or treat temporomandibular joint disorder have been used for decades.  More recently, dentists have been advertising appliances that treat snoring and sleep apnea. In this edition of Townsend e-Letter, journalist Bob Frost introduces us to SOMA (Splint Orthopedic Myofunctional Appliance), developed by Australian dentist Joseph Da Cruz. This customized, adjustable plate, made of acrylic plastic, fits onto the upper teeth; but the design is less restricting than conventional oral appliances, according to Dr. Da Cruz’s US patent.⁶

SOMA is designed to gently move the jaw into its proper alignment and, thereby, relax facial and jaw muscles, resulting in cranial release. Reducing muscle tension has multiple beneficial effects on the entire body. Headaches, sinus congestion, sleep-disordered breathing have been relieved with the device, according to Dr. Da Cruz’s website.⁷ Moreover, the nervous system throughout the body calms, and healing parasympathetic activity increases. In line with biological dentistry, SOMA removes stress so that the body’s innate healing mechanisms are free to do their work.

Dr. Da Cruz “has lined up his ducks and is ready to tell the world about his work,” writes Frost. The device is patented, a laboratory is ready to make appliances, and his staff is developing an online program to instruct interested dentists who cannot visit him in Australia. SOMA offers a new way to increase general health and wellbeing.

References

1. Jefferson T, Dooley L, Ferroni E, et al. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database of Systematic Reviews 2023, Issue 1. https://pubmed.ncbi.nlm.nih.gov/21735402/
2. CDC, FDA, and NIH Leaders Testify on Covid-19 Response. February 8, 2023. https://www.c-span.org/video/?525878-1/cdc-fda-nih-leaders-testify-covid-19-response
3. Dr. Carl Heneghan Interviews Dr. Tom Jefferson About His Major New Study Showing Masks Have No Clear Effect. February 6, 2023. https://dailysceptic.org/2023/02/06/dr-carl-heneghan-interviews-dr-tom-jefferson-about-his-major-new-study-showing-masks-have-no-clear-effect/?highlight=Dr.%20Carl%20Heneghan
4. Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ. November 2, 2021.
5. Thacker PD. Researchers Find No Evidence (Again!) of Mask Effectiveness, Yet Self-Styled Experts Continue Promotion. February 7, 2023. https://disinformationchronicle.substack.com/p/researchers-find-no-evidence-again
6. https://patents.google.com/patent/US7661955B2/en
7. Da Cruz J. What Does SOMA Do. https://wholisticdentistry.com.au/what-does-soma-do/

Published April 8, 2023