Introducing Transparency
Deciphering medical literature on controversial topics and empowering everyday people to communicate confidently.Everything You Need to Know about the COVID 19 Vaccine
Our free guide will get you up to speed quickly and summarize trial results, government reports, and all publicly known knowledge about the vaccine.
How to Have Controversial Conversations With Your Significant Other
Article Summary The reason that speaking with others about controversial topics is so difficult is that cognitive dissonance is a physical reaction our brain uses to protect itself. 3 universally useful steps to help you talk to your significant other without causing this physical reaction are: setting boundaries, using rapport (specifics are included), and asking the right questions. I have probably heard this sentence over a thousand times the past year-- "We are just so divided these days. You can't talk to anyone without it becoming controversial." We have definitely seen a shift in communication, not just in the past year and a half, but truly in the past ten years as we have become more technologically focused. We scroll, click and comment rather than picking up the phone or seeing people in person. And although this past year has been significant in shining a light on what may seem like "warring factions" the shift in the way in which we communicate has not only left us with very few communication skills to handle such a tirade of opposing thought, it has also left many partners and friends feeling that there is no way for them to speak to each other about their own beliefs and opinions. How do you get through to someone when they have a completely opposite view on an issue than you do? Especially without damaging your relationship with that person. Most especially when that person is your significant other? The Difficulty of Talking to Your Significant Other About...
Was an Inert Placebo Used in the COVID-19 Vaccine Trials?
Article Summary The AstraZeneca Vaccine was not tested against an inert placebo, rather it was tested against a mixed group of placebo and the meningococcal vaccine. (Source from UK government).The meningococcal vaccine was also never tested against a placebo when licensed. (Statements from the manufacturer shown below.)The vaccines used in the USA were obligated by petition to use an inert saline placebo during phase two and three trials. (Petition and FDA statement below.) Because of the perceived ethical controversies of using an inert placebo in vaccine trials most vaccines are not tested against an inert placebo. This leads to the question of whether or not the Covid-19 vaccines granted emergency use authorization were tested against a saline placebo. The answer is a little more complicated than you might expect. Different Placebo Choices for Countries' Vaccine Trials Not every country has the same approval processes or trial processes in approving or creating a vaccine. Therefore since the vaccines widely distributed come from two different countries the answers will be a bit different for each. Although it is common world-wide to always test a vaccine against another vaccine and not against an inert placebo, there has been much scrutiny placed on the COVID-19 vaccines and their development. This scrutiny inspired a different approach in the US than in the UK. In the United Kingdom, where the AstraZeneca vaccine was produced, the government information for healthcare...
Why Vaccines Replaced Placebos
Article Summary The FDA has stated that including a control group when testing vaccines is unethical because vaccines are a proven "effective intervention". Most vaccines are tested against other vaccines (multiple examples below) which makes it difficult to determine their effectiveness. Before I started diving deeper into research on vaccines I had always thought, of course, before putting vaccines on the market each manufacturer must do studies with an inert placebo to be approved by the FDA. That's the FDA approval process for every other drug- it is simple science. So vaccines would not be any different. However, upon further inspection I found that in the world of vaccines the protocol for trials has been different than other pharmaceutical products, all the way back to the early 1950s. Why a Placebo group in a Vaccine Trial is an Ethical Controversy In 2008 the WHO published ethics guidelines and although acknowledging that, "when the objective of a study is to establish the safety of a new vaccine, the use of a placebo is much more likely to produce a scientifically reliable result than the use of an active control,” They further went on to state: "as a general rule, research subjects in the control group of a clinical trial of should receive an established, effective intervention. In some circumstances, it may be ethically acceptable to use a placebo or "no treatment.” What is an "active control" and what do they mean by "an established effective...
Johnson and Johnson get their Shot at Covid-19 Vaccine EUA
Johnson and Johnson recently announced that they have met their COVID-19 vaccine trial's primary endpoint. They are now seeking Emergency Use Authorization from the FDA for their one-dose vaccine for Sars-Cov-2 called JNJ-78436735 or Ad26.COV2.S by J&J's pharmaceutical arm Janssen who developed the product. A meeting will be held on February 26, 2021, to determine if the first single-dose vaccine will receive emergency use authorization. According to Johnson and Johnson the vaccine is overall 66% effective in preventing moderate to severe COVID-19, 28 days after vaccination. Unlike Pfizer and Moderna this vaccine leverages a more traditional vaccine technology called AdVac. Instead of using mRNA, AdVac is a vector (carrier) technology, the vector is based on a genetically modified version of the adenovirus, which carries in the genetic code of an antigen (pieces of viruses, bacteria, or pathogens). Explained by Janssen: "The AdVac® technology works by using an adenovirus as a vector (a carrier) of an antigen’s genetic code, to mimic components of a pathogen (a bacterium, virus, or other disease-causing organisms). Antigens (components of a pathogen) are produced to mimic the pathogen, without causing severe disease." Although this technology has produced several vaccine candidates for viruses such as HIV, RSV, and Zika it has never been licensed in the United States. The previously mentioned vaccines are currently only candidates. Janssen's Ebola two-dose regimen...
AstraZeneca and the Aborted Fetal Tissue Question
Article Summary Tissue from aborted fetuses, called human cell lines, was used to grow the spike protein used in the AstraZeneca Covid-19 vaccine. (Vaccine insert from manufacturer shown below).Many vaccines use human cell lines in the creation process of vaccines (CDC ingredient list is shown below).Although most of the tissue is removed before the vaccine goes to market it is impossible to filter out all the debris and DNA. (FDA statement is shown below).Human DNA in vaccines can have harmful effects such as carcinogenicity, as documented by the FDA. Recently the AstraZeneca Covid-19 vaccine was approved for use in the UK and is being widely distributed. This vaccine uses more traditional mechanisms than the Moderna and Pfizer vaccines and thus, the use of aborted fetal tissue is a concern. There was even a viral video of the packaging showing cell-lines as an ingredient. After which, many articles were written purporting to have "debunked" this claim. However, now that the vaccine ingredients have been released to the public it is clear that there is still cellular debris from aborted fetal tissue in the vaccine (please see section 2 and the screenshot below). Ingredients of the AstraZeneca Covid Vaccine HEK-293 cells were obtained in the 1970s from an aborted female fetus, of unspecified origin by Dr. Frank Graham. The name HEK293 was put on this cell line because it was Frank Graham’s 293rd experiment. Usually, they are used for testing food products, however, many...
Adverse Events of the COVID-19 Vaccines
It has been a few weeks since both the Pfizer and the ModernaTX vaccine have been released. As of December 31, 2020, according to the Department of Health and Human Service's vaccine adverse reporting system, there have been 16,054 adverse events from the Covid-19 vaccinations in the United States (to access this data you need to be login. Some of the most serious and common side effects listed are: 10 reported deaths841 headaches557 cases of nausea511 cases of chills464 cases of pyrexia472 cases of paraesthesia397 rashes233 cases of chest pain and discomfort212 cases of palpitations2,014 cases of tachycardia151 cases of vomiting167 cases of urticaria253 cases of throat irritation86 cases of tremors107 "unevaluable events" There are hundreds of other side effects listed including 2 autoimmune disorders. However, it is difficult to assess how accurate these numbers are or if they are related to the vaccine. VAERS allows anyone who has been vaccinated to submit a report. However, rather than there being an overflow of reports, injuries are vastly under-reported. If you read my post about vaccine liability you know that a CDC commissioned study by Harvard Pilgram found that less than one percent of adverse events are ever reported. The COVID-19 Vaccine Reporting It seems that this vaccine is following a similar route. Although there appears to be a significant increase in reporting on adverse events than there has been with other vaccines, adverse events are still being...
Moderna Vaccine: The Current Unknowns
On December 17, 2020, Moderna submitted a 54-page document to the FDA containing the data from their vaccine trials. When compared to Pfizer's original data, there are some obvious differences although the two are using the same technology and had a similar demographic and number of participants in their trials. One of these differences doesn't have to do with adverse events or efficacy data, (though I will be dissecting those as I update our guide, Everything You Need to Know about the COVID-19 Vaccine), it has to do with declaring the unknowns of this vaccine. Specifically the known unknowns. The Beginning of the Unknown Starting on page 48 Moderna lists "Unknown Benefits/Data Gaps," these include: Duration of ProtectionEffectiveness in certain populations at high risk of severe COVID-19Effectiveness in individuals previously infected with SARS-CoV-2Effectiveness in pediatric populationsFuture vaccine effectiveness as influenced by characteristics of the pandemic, changes in the virus, and/or potential effects of co-infectionsVaccine effectiveness against asymptomatic infectionVaccine effectiveness against long-term effects of COVID-19 diseaseVaccine effectiveness against mortalityVaccine effectiveness against transmission of SARS-CoV-2 Although I would love to dig into each one of these unknowns, many of the above speak for themselves, so let's just take on the important or more complicated issues. 1. Duration of protection The vaccine trials only lasted for around 8...
Why Weren’t There More Cases of COVID-19 During the Pfizer Trial?
It has been nearly impossible to keep up with all the additional data emerging about the COVID-19 vaccine from both Pfizer and Moderna TX. I already feel like I need to make many updates to my guide, Everything You Need to Know About the COVID-19 Vaccine. However, I don't want to put out a brand new copy every time there is the tiniest update in my analysis. So, I thought, instead I would give you a quick sneak peek here in a blog post, to get the information out and the wheels turning. New Data on Efficacy Hidden Within the Pfizer Trial We have all heard multiple times that the Pfizer vaccine's efficacy rate is somewhere around 95%. This efficacy rate is defined from the following data (from the same source), "The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group." The first thing I thought after reading this data was, "one hundred and seventy cases is an incredibly small sample size to base complete efficacy data from." Especially when the entire purported population of the study was over 35,000 individuals. It seems as though these were the only cases based on the way that efficacy has been reported by Pfizer as well as by the FDA However, we are often reminded that cases are skyrocketing, in the US and all over the world, so, even though the study period was quite short, should we not have seen more cases in...
Vaccine Liability: How Vaccines fit into the Legal Picture
We often hear people in movies say things like, "I'll sue you," or see scenes of our hero meeting with lawyers and using the system to get justice. But, what do the words, "I'll sue you," really mean in the context of pharmaceuticals and vaccines? You may have heard about the recent lawsuits against Johnson and Johnson or Bayer's subsidiary Monsanto due to evidence that their products cause cancer. The damages for these claims total over 11 billion dollars. Both of the items in question are household products, used for years. One, a talcum powder used for baby diaper rashes, and the other a weed killer. Things the average American doesn't give any thought to using. If this is the case with ordinary products with a history of long-time use, what about things that play a much larger chemical role in our lives? If a drug causes someone injury, how does that person get redress? There are a couple of ways this is done. Most of the time, when a drug has harmed someone, that person can file a personal injury claim. This is different than a medical malpractice suit, which is specifically filed to sue a particular health care provider or pharmacist. A personal injury claim, in the case of pharmaceuticals, is much like a product liability claim. The short of the long of it is, the plaintiff (or the person who is claiming injury/defect) can file a suit against the manufacturer of the product to get redress for harms done. A Preponderance of Evidence In that suit, the plaintiff has the...
19th Century Mortality Rates: Why did Deaths from Disease Suddenly decrease by 74%?
Those of you who read my post about herd immunity may be asking yourself this question: "If America has never reached the medical standard of herd immunity, (a 95% vaccination rate), why aren't people dying from disease left and right?" "Why aren't people dying from as many sicknesses as before?" Which leads to the question of, what caused the 74% mortality rate decrease from the late 1900s until now? [I want to put in a caveat before I begin this post - I will specifically be speaking about mortality (or the death rate) dropping. This post is not specifically about morbidity, (or the number of people infected). I will address morbidity in a separate post, there is far too much to address both of these topics in one sitting.] Mortality Rate Answers from the CDC: So, let's get back to answering the question of why mortality rates dropped by 74% in the twentieth century. First, I will turn to the CDC to answer what is not responsible for the 74% decline in mortality. In 2000 the CDC, along with doctors at John Hopkins produced a study in Pediatrics called, "Annual summary of vital statistics: trends in the health of Americans during the 20th century." The study aimed to understand the large drop in Mortality in the twentieth century compared to centuries past. This was their explicit analysis: “Thus vaccination does not account for the impressive declines in mortality seen in the first half of the century…nearly 90% of the decline in infectious disease mortality among US...