April 12, 2020

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Introduction to Vaccine Safety

Is vaccine safety data spun, distorted, and magnified - through media - similarly to how effectiveness data is presented?

 

The short answer is Yes! 

 

HHS admitted this publicly in 1984, saying "doubts..about the safety of the vaccine cannot be allowed to exist." It can't get anymore clear than that!

 

So, this next series of articles will show you how scientific facts about vaccine safety are either magnified, distorted, or denied completely, all to positively influence your opinion about vaccines. At no point in time am I saying there is zero scientific evidence which supports what the pro-vaccine are saying. What I'm saying is that media and the Health Authority spin VACCINE MESSAGING in such a way, that the scientific truth is misrepresented and the claims they make are not supported or proven by the data they point to.

 

Before moving into the discussion about vaccine safety, I feel it’s important to provide you with a recap of five key pieces of safety information that were presented in the links within the previous articles. After recapping those points, I'll provide you with some brief historical background that relates to the discussion that will come in future articles.

 

ONE: In Ch2: Part 1, Dr. Richard Horton, Editor-in-Chief of the Lancet, explained that we can't believe much of the scientific research published in the medical journals anymore. Dr. Richard Horton explained that science has taken a turn towards darkness, with possibly half of the scientific literature being untrue. He explained that scientists are not incentivized to be right, and that the actions of many researchers is veering into misconduct. In a link provided in that same article, Dr. Ben Goldacre explains during his TEDMED talk that we can't trust the medical journals anymore, because a vast majority of important scientific research is NOT being published. He explained that pharmaceutical companies, and their sponsored physicians refuse to publish research that shows unfavourable results for pharmaceutical drugs. Because positive research is significantly more likely to be published than negative research, that publication bias has hijacked the medical literature and the medical journals. 

 

TWO: In Ch2: Part 2, I explained that David Graham, the FDA whistleblower, provided testimony before the USA Government, stating that the FDA as currently organized, is incapable of protecting the American public from unsafe drugs. In an interview, he stated that that drug safety testing is very poor because the FDA assumes the drug is safe and requires the manufacturer to prove the drug’s isn't safe, with 95% certainty. He stated that of course a company does not go out of their way to discover and show serious harms, recognizing that serious harms will likely prevent the drug from being licensed. He explained that proving a drug is unsafe, with 95% certainty, is impossible to do. And so, the FDA's assumption of safety, is always declared proven.

 

THREE: In Ch2: Part 1, Dr. Marcia Angell, a Harvard lecturer and former Editor-In-Chief of the New England Journal of Medicine, stated in a lecture she gave that you cannot trust a lot of the clinical research published in medical journals anymore. She explained that the true safety evaluation for a drug occurs post-marketing, which means AFTER a drug has been approved and licensed. She stated that a good understanding of safety cannot be obtained in pre-licensing testing because in those trials, drugs are tested in isolation from other drugs, and they are tested on a small number of healthy, strong young people, who are less likely to experience side effects. She said that not until a drug is on the market, and being used widely on 100,000s people of all health status, in combination with other medication exposures, can a more accurate safety measurement be observed and evaluated.

 

With Angell's comments in mind, you need to reflect back on a quote made by Graham during his testimony. He said:

When a serious safety issue arises post-marketing, [the FDA's] immediate reaction is almost always one of denial, rejection and heat. They approved the drug so there can’t possibly be anything wrong with it. The same group that approved the drug is also responsible for taking regulatory action against it post-marketing. This is an inherent conflict of interest.

 

To add further that statement, I'd like to bring your attention back to a comment he made in his 2005 interview. He stated the following:

Another aspect to the culture at the FDA is that it overvalues the benefits of drugs and undervalues the risks of drugs. And so the FDA will always say to you, "Well, we're leaving this drug on the market because the benefits exceed the risks." Well, the FDA has never assessed the benefit of any drug that it's ever approved. It works on what's called efficacy. Does the drug work or not? Does it lower your blood pressure or does it lower your blood sugar? Not: Does it prolong your life? Does it prevent you from having a heart attack? Those are benefits. All they focus on is efficacy. 

 

For example, ask the FDA why on earth they didn't ban high dose Vioxx® after the VIGOR Study showed in early 2000 that it increased the risk of heart attack by 500 percent? High dose Vioxx® was approved for the short-term treatment of acute pain. What earthly benefit was there that exceeds a 500 percent increase in heart attack risk? Ask the FDA to produce its benefit analysis that shows that the benefits exceed the risks. It doesn't exist. The FDA has never looked at benefit. The FDA just says to the American people, "The benefits exceed the risks. Trust me. Believe me." If you held the FDA to its proof the American people would see how badly served they've been by the FDA and its culture that belittles safety in the drug companies' interest. 

 

If the FDA were to pull a drug due to safety issues, it would hurt the marketing of the drug. It might also call into question why they approved the drug in the first place. Therefore, you get this culture of cover-up, this culture of suppression, this culture of denial, and this culture that demonstrates above all else that industry is the client and not the American people.

 

FOUR: In Ch3: Part 5, Cochrane evaluated the data from numerous flu vaccine clinical trials, which included data on thousands and millions of vaccinated people. The Cochrane evaluation concluded, “No evidence of association with serious adverse events was found, but the harms evidence base was limited.”

 

Such a statement should be surprising for people to hear. The "evidence base was limited." That doesn't mean the harms were limited, that means the data was limited.

 

How can the data be limited, when the research involved up to eight million people. Eight million! Unfortunately, despite those various studies looking at thousands or millions of people, the studies were not designed properly, to gather the necessary data on harm, data which could have allowed for evaluation of the serious adverse events. Why are the studies not being designed properly, to gather adequate safety data? 

 

FIVE: In Ch2: Part 3 you learned the issue that most seriously affects the entire medical system on the vaccine front. In 1984, the USA Department of Health and Human Services, the highest level of government that oversees the CDC, the FDA, the NIH, and other American health agencies, HHS instructed all their subordinate agencies that "any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives."

 

When the highest level of government is stating that propaganda and censorship must be used to maintain positive vaccine support, then that means our medical doctors are being taught propaganda, not science.

 

The practices of the CDC, FDA, and NIH are modelled by other countries around the world. And therefore, USA propaganda has influenced global vaccine public health policy and action.

 

This issue of propaganda and censorship leads us to a key historical event.

 

Historical Background

Each of the publications listed and explained below had a profound affect on today's vaccine safety discussion.

 

In 1998, a vaccine/autism connection was hypothesized in a published paper, of which one of the 13 authors on the study was Dr. Andrew Wakefield. Today, this is the paper you always hear referred to as “that fraudulent paper” published by "that fraud and delicensed doctor." It is often said that both Wakefield and that single paper are to blame for the entire anti-vax movement.

 

In the early years following publication of that paper, the world governments didn’t believe the paper was fraudulent, and so from 1998-2004, the CDC decided to look further at a vaccine/autism hypothesis. CDC scientists subsequently researched two vaccine questions in different studies. One question was related to thimerosal exposure and autism prevalence, and the second question was related to age of exposure to MMR vaccine and autism prevalence. 

 

Around this same time, the Institute of Medicine (IOM), which serves as an adviser to the USA Government on health policy and practices, they were also tasked with evaluating vaccine safety. The IOM created a specific committee to work on this project, which they named the Immunization Safety Review Committee. This committee prepared a report which was finalized in 2004, titled Immunization Safety Review Vaccines and Autism. That review relied heavily upon a few autism studies, which included those CDC studies mentioned above. In 2004, the final IOM report concluded that the vaccine autism hypothesis is weak and not worth studying with targeted research. That review also provided advice to the USA Government, directing what types of autism research the government should support and fund in the future. (More on this IOM Report in two articles from now: Ch4: Part 3)

 

 

CONTINUE to the next post here: Ch4:Part 2

 

 

Article Sources

  • Letter by Dr. Richard Horton - that science has taken a turn towards darkness Here

  • Ted Talk by Dr. Ben Goldacre Here

  • David Graham's testimony to US Government Here

  • Interview with David Graham Here

  • Lecture by Dr. Marcia Angell Here

  • HHS Instruction - Well founded vaccine safety concerns cannot be allowed to exist Here

 

Last updated February 4, 2018

 

 

 

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