In essence, society’s attention has become focused on vaccination, focused solely on this health treatment. But TREATMENT is not what creates health, treatment is what changes or manages a persons’ symptoms of poor health. Instead of focusing solely on the treatment, there needs to be a shift. We need to evaluate the treatment in the context of the whole - what is working about the treatment? What needs improving? What is failing completely? How does the treatment affect evolution of the species? And how can health be supported moving forward so that the treatment is no longer needed?
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May 18, 2018

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May 18, 2018

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Introduction to Vaccine Safety

Lets move our vaccine discussion beyond efficacy, for now, and instead turn our attention to safety. Again, the focus of discussion in this next series of articles will be 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. The science that the pro-vaccine point to is often completely true (when it hasn't been fraudlently manipulated). The point you will hear me argue often, is that media and the Health Authority often 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.


An important point of note to make, moving into the safety discussion, is that there is a considerable body of scientific evidence which is being ignored completely and censored. Though the research exists, it is NOT being brought to the attention of the public at all, and the existence of it is even being denied. That supressed science reveals issues and problems, and until people are aware and demand change, the problems will persist. Before moving into the discussion about vaccine safety, I feel it’s important to provide you with a recap of six key pieces of safety information that were presented in the links within the previous articles. And then to conclude, I'll provide you with some brief historical background that relates to the discussion that will come in future articles.


ONE: In Safety & Efficacy - Part 1, Dr. Richard Horton 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 Safety & Efficacy – Part 2, I explained that David Graham, the FDA whistleblower, provided testimony before the US Government, stating that the FDA as currently organized, is incapable of protecting the American public from unsafe drugs. In an interview, he stated that pre-licensing efficacy testing is good because the FDA requires that the drug company shows that the drug works, (for vaccines, this means the drug is effective at generating an antibody response). Whereas he stated that safety testing is very poor because the opposite happens, the FDA assumes the drug is safe and then 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 therefore, the FDA's assumption of safety, is declared true.


THREE: In Safety & Efficacy – 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 and is therefore being used widely by the public. She stated that a true reflection of safety in pre-licensing trials cannot be obtained 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, and 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:

The organizational structure within [the Center for Drug Evaluation and Research] CDER is entirely geared towards the review and approval of new drugs. When a CDER new drug reviewing division approves a new drug, it is also saying the drug is “safe and effective.” When a serious safety issue arises post-marketing, their 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.


So, reflecting on Angell's statement, a drugs true safety profile can't be understood until it's licensed and used widely by the public, with thousands or millions of people taking it. And Graham says that even in post-marketing when the safety profile is better understood, even if serious problems are suspected, the FDA would be unwilling to pull it from market.


FOUR: In Safety & Efficacy – Part 7, 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, it 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 information? I leave you to answer that question for yourself.


FIVE: And the issue that most seriously affects the entire medical system, is the fact that the US Department of Health and Human Services, the highest level of government that oversees the CDC, the FDA, the NIH, and other American health agencies, 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 learning propaganda, they are not learning science or medicine. And if our doctors and society as a whole are being taught propaganda, then the vaccine safety issues that exist, those issues are being ignored, and silenced. As a results, the problems persist and are not being corrected. 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 two 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 US 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 that had been submitted for analysis to the IOM, of which two of those studies were the CDC studies mentioned above, the thimerosal exposure and age of administration of MMR studies. In 2004, the final IOM report concluded that the vaccine autism hypothesis is weak. That review also provided advice to the US Government, directing what types of autism research the Government should fund and support in the future. (More on this IOM Report in two articles from now: Safety & Efficacy – Part 12)


CONTINUE to the next post here: Safety & Efficacy - Part 11


Article Sources

David Graham's testimony to US Government Here

Interview with David Graham Here

Lecture by Dr. Marcia Angell Here


Last updated February 4, 2018




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