Saturday, September 25, 2021

How Good Is the Science on COVID Vaccines?/ AAPS' Jane Orient, MD

 

COVID-19: How Good Is the Science on COVID Vaccines?


        I’m sure you are favor of “following the science” on COVID vaccinations.

        A basic principle of the scientific method is that you need a control group. To detect a difference, say in adverse reactions, between the treated group and the control, you need a big enough control group. As this graph shows, you need to have 50% in the control group to be sure that you have at least an 80% chance of detecting a statistically significant difference.


        If 70% are vaccinated, only 30% are in the control group, and the statistical power is falling rapidly as more unwilling persons get the jab to keep their job.

        The Biden Administration is calling for 70% of the world population to be inoculated and pledging to donate 500 million doses of the Pfizer-BioNTech product to low and lower-middle-income countries and the African Union. 

        Another absolute requirement for scientific research is complete reporting. Probably, 90% or more of adverse reactions are not reported to the Vaccine Adverse Reactions System (VAERS). As revealed by Project Veritas, reporting may be actively discouraged.

        I have been told of highly trained pilots being grounded post-vaccine because of severe migraine or cognitive problems, of sudden appearance of terminal cancer, of athletes who cannot play because of heart problems, of sudden paralysis or onset of seizures. We can’t say it was because of the vaccine. Is it more common after vaccination? Without meticulous follow-up and a control group, we don’t know.

        The worldwide, coercive mass vaccination campaign is unprecedented, but because it lacks a control group it would be incorrect to call it a scientific experiment. Ethical research would, in addition, require voluntary informed consent, free medical care of subjects who experienced complications, provision to stop the experiment if it is doing harm, and these days an Institutional Review Board.

 

        Additional information: 

·         For a compendium of suggested treatment protocols and possible sources of care, see c19protocols.com.

·         For suggested student or employee response to COVID vaccine mandates, see aapsonline.org.

·         Download and share the updated AAPS Guide to Home-Based COVID Treatment.

 

Jane Orient, M.D.

Executive Director

Association of American Physicians and Surgeons, jane@aapsonline.org


 

3 comments:

  1. Jane Orient's name is not on the original webpage.

    ReplyDelete
  2. Jane did write it, as she sent it to me. She is the Executive Director of the AAPS, and so does not always sign AAPS materials, I think.

    ReplyDelete
  3. "As this graph shows, you need to have 50% in the control group to be sure that you have at least an 80% chance of detecting a statistically significant difference."

    With respect, that's not universally true. It's a gross oversimplification that could get us into trouble if we start parroting it to anyone familiar with statistical methods and analysis.

    There are plenty of well designed studies with strong statistical power in which the ratio between case/treated and control/untreated groups is greater than 1:1 (> 50%). Plenty of good case-control studies use ratios of 2:1, 3:1, 4:1, and even higher. There is nothing inherently wrong with a well-designed clinical trial that uses a case-control ratio of 70:30 - as long as there is sufficient statistical power built into the study design.

    In typical clinical trials, statistical power is about *how many subjects* are needed in each group (e.g., before vs after treatment, or treated vs control) in order to show a *statistically significant difference between groups* in the outcome of interest (e.g., incidence of infection or hospitalisation), with the confidence level or 'power' selected (commonly 80%, but can be higher). That is a function of *how uniform (homogeneous)* each group is, or how much variation there is amongst the group members. The more diverse (heterogeneous) the group, the higher the standard deviation from the mean, and the more subjects it takes to show a statistically significant difference between groups at the power level selected.

    And BTW, there is nothing magical about 80% power. It's a commonly used threshold, but it still means that the study design is conceding that *chance* may account for the difference 20% of the time.

    With huge, population-level studies that involve many thousands or even millions of subjects, the statistical power is inherently great - as long as the study design is sound. There is *huge* variation amongst study participants in these population-level studies, but there are so many people in each group that statistical power is generally not a problem. In addition, signals which may be completely obscured in a smaller study are more easily detected at the population level.

    One of the *many* problems with this vast vaccine experiment is that the control group is unintended and thus uncontrolled. In fact, it is now systematically being obliterated (vaccine mandates, considerable societal pressure to get vaccinated, etc.).

    It is no longer true that the treatment (vaccinated) and control (unvaccinated) groups are the same in every other respect (i.e., that the primary difference between the two groups is the investigational intervention).

    It is also no longer true that the treatment (vaccination) is a uniform and definable thing. Many people have "dropped out" after the first injection of the two-shot products (Pfizer, Moderna, Astrazeneca, etc.), while some people will be getting a third shot. So, the treatment arm of the study is now as useless as the control arm.

    As a clinical study or even as postmarket surveillance, it is a complete debacle! No reputable journal would publish the results of such a study because it is not only poorly controlled, it is downright uncontrolled and now uncontrollable. Any institution that had attempted such a travesty of a scientific study would lose all credibility and possibly its accreditation.

    To put it all far more simply, "What happened to the control group?" is question enough all on its own. It is not only a complete sentence, it's a complete condemnation of this whole sorry thing.

    So, let's just keep repeating "What happened to the control group?"

    Or if you prefer, "Where's the control group?"

    Me, I'm just quietly and confidently asserting to anyone who dares to question my vaccination status, "I'm in the control group." And I leave it at that.

    ReplyDelete