Why Did the CDC Silence the Million Dollar Harvard Project Charged With Upgrading Our Vaccine Safety Surveillance System?

There are major problems with the vaccine adverse event reporting system (known as VAERS) which the CDC considers the “front line” of vaccine safety. VAERS was created in 1990 by the CDC and FDA as a means to collect and analyze adverse effects that are associated with vaccines. Unfortunately, the failings of VAERS are “kept from the consciousness” not only of the public, but also from the doctors, pediatricians, and nurses that the public rely on to provide reliable information as to the safety of vaccines. I say “kept from the consciousness” rather than “kept secret” because while these failings are publicly disclosed for all the world to see, they are for all intents and purposes BURIED in documents seldom searched out by the average member of the medical community, much less by the average individual. You could say that the information has been very effectively hidden in plain sight.

By far, the most dire failure of the VAERS system is the vast underreporting of vaccine adverse effects which leads to a dangerous false security in vaccine safety and an erroneous assumption that the benefits of vaccination far outweigh the risks.

Who DOES know about the deadly elephant in the room?

The CDC, the FDA, the Institutes of Medicine (IOM), and Congress to name a few. Oh, and an organization called Harvard Pilgrim Healthcare, Inc.- but we’ll get to them in a minute.

This is what the CDC says about the VAERS system, “Passive surveillance systems (e.g. VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible.” (emphasis mine)

In 2000, the 6th Report by the Committee on Government Reform addressed the failings of VAERS in its address of the Vaccine Injury Compensation Program. The report states, “The quality of VAERS data has been questioned. Because reports are submitted from a variety of sources, some inexperienced in completing data forms for medical studies, many reports omit important data and contain obvious errors. Assessment is further complicated by the administration of multiple vaccines at the same time, following currently recommended vaccine schedules, because there may be no conclusive way to determine which vaccine or combination of vaccines caused the specific adverse event.”

The same Congressional report notes (on page 19), “Former FDA commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.” (emphasis mine)

The Congressional report above listed 4 limitations that the IOM Committees noted, “1) Inadequate understanding of biologic mechanisms underlying adverse events; 2) Insufficient or inconsistent information from case reports and case series; 3) Inadequate size or length of follow- up of many population- based epidemiological studies; 4) Limitations of existing surveillance systems to provide persuasive evidence of causation; and 5) Few published epidemiological studies.” The report continues by noting that the “IOM warned that ‘if research capacity and accomplishments [are] not improved, future reviews of vaccine safety [will be] similarly handicapped.’”

The IOM has been telling the CDC for over 23 years that they have inadequate information (and none at all in some cases) to advise on the causal relationship between vaccines and adverse events for a majority of adverse events reported. In a 1994 report on vaccines and adverse events the IOM stated, “The lack of adequate data regarding many of the adverse events under study was of major concern to the committee…Although the committee was not charged with proposing specific research investigations, in the course of its review additional obvious needs for research and surveillance were identified, and those are briefly described here.” (emphasis mine) In 2011, the IOM conducted another study examining the scientific evidence in studies available for 158 vaccine adverse effects. Again, they concluded that they had inadequate information to come to a decision, “The vast majority of causality conclusions in the report are the evidence was inadequate to accept or reject a causal relationship.” (emphasis mine)

While one might expect a new program (new in 1990) to have a few bugs that need to be worked out, I would expect that when it comes to being able to ascertain vaccine safety, working out those bugs should be priority number one. Certainly today in 2017, a whopping 27 years later, the failure of the CDC to address this monumental danger to public health should be viewed with a skepticism much greater than mere suspicion.

That leads us to the interesting case of the CDC and Harvard Pilgrim Healthcare Inc.

The Department of Health and Human Services (HHS) gave Harvard Medical School a $1 million dollar grant to track VAERS reporting at Harvard Pilgrim Healthcare for 3 years and to create an automated reporting system which would revolutionize the VAERS reporting system- transforming it from “passive” to “active.”

This project was called Electronic Support for Public Heath- Vaccine Adverse Reporting System (ESP:VAERS). According to the grant final report, the scope of the project was, “To create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs.” To accomplish this the team used the electronic medical records at Harvard Pilgrim Healthcare, Inc, which is described as a “large multi-specialty practice.” Every patient that received a vaccine was automatically identified and followed for 30 days. Within that 30 days the individual’s diagnostic health codes, lab tests, and prescriptions were evaluated to recognize any potential adverse event. Another goal of the project was to evaluate the performance of the new automated system via a randomized trial and to compare this new data to the existing data collected by VAERS and Vaccine Safety Datalink.

Just the preliminary description of this program is head and shoulders above the current functioning of the passive VAERS system. In our current system, adverse events are to be spontaneously reported by parents or health care providers. Most parents aren’t even aware the VAERS system exists, much less aware that they are supposed to be reporting to it. Health care providers are “supposed” to report adverse events, but we have no idea of the efficiency level with which this is occurring, and more than a hunch that this reporting is grossly neglected for a variety of reasons. Furthermore, many vaccine adverse events are never reported because either the parent, patient, or doctor is completely unaware that a subsequent adverse event is in fact due to a vaccine. This new reporting system would remove all of these failures from the equation.

What were the results?

Data was collected from June 2006 to October of 2009 on a total of 715,000 patients. Of those 715,000 patients, 376,452 were given 1.4 million doses of 45 different vaccines. A total of 35,570 possible adverse reactions were identified, so 2.6% of vaccinations were followed by a possible adverse reaction.

Let’s just take a minute to reflect on that last sentence. Out of only 376,452 individuals that received a vaccine at this Harvard practice, the new automated system identified 35,570 possible adverse reactions in a three year period. How does that stack up to the number of adverse effects reported to VAERS? According to the CDC, only 30,000 adverse events are reported every year for the entire US population. This finding alone should have had the CDC saying:

I’ll quote the findings directly from the report, “Adverse events from drugs and vaccines are common, but underreported. […] Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of ‘problem’ drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed.”

Again, let’s stop and think about this revelation for a moment: fewer than 1% of vaccine adverse events are reported. The CDC’s entire vaccination propaganda campaign rests on their claim that side effects from vaccination are exceedingly rare (and predominantly minor). According to the CDC, in 2016 alone, VAERS received 59,117 vaccine adverse event reports. Among those reports were 432 deaths, 1,091 permanent disabilities, 4,132 hospitalizations, and 10,274 emergency room visits. What if these numbers actually represent less than 1% of the total as this report asserts? Simple multiplication would yield vaccine adverse events reports numbering 5,911,700!

Of course, at this point that figure is nothing but a guess. But, again, why do we HAVE To guess? Because in 27 years the CDC has failed to provide a post- licensure vaccine safety surveillance system that the IOM, FDA, physicians, and the public can have confidence in.

The report also states, “Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of the clinician’s usual workflow, takes time, and is duplicative.

So, WHY aren’t the reports currently being made to VAERS? According to the findings above, clinicians don’t know for sure what a vaccine adverse event is. This isn’t surprising at all considering what we learned from the 2011 IOM report above. There haven’t been enough studies performed for highly trained IOM scientists and physicians to even determine whether or not the majority of the currently suspected 158 adverse vaccine effects are indeed caused by vaccines. How could we possibly expect our average pediatricians or general practitioners to know what a team of IOM personnel have determined we have inadequate information to decide? In addition, this report basically finds that your clinician frankly doesn’t have the time to devote to proper VAERS reporting under the current inconvenient system.

You’d think that the CDC would be jumping for joy that this Harvard team just created a proactive, reliable, automated system that would improve the quality of our vaccination program by improving vaccine adverse event detection thereby increasing public confidence in post- licensure surveillance.

What was the CDC’s response?

Basically, the same response your average college student falls back on when they decide they are no longer interested in continuing a relationship- they cut all lines of communication. No more answering phone calls or emails. You heard me correctly, the United States of America Centers for Disease Control ghosted Harvard Pilgrim Healthcare, Inc. For those who are unaware, Google dictionary defines ghosting as, “the practice of ending a personal relationship by suddenly and without explanation withdrawing from all communication.” Personally, I would hope that I could hold an organization like the CDC to a higher standard, but…

After a one million dollar grant was paid and three years of research conducted on what appeared to be a very successful upgrade to the passive VAERS system, the team’s CDC contacts went MIA. The ESP:VAERS final report states, “Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”

According to the final report, the only thing left for the CDC to do was link the VAERS system to the Harvard Pilgrim system in order to transmit the data. The team requested that the CDC do this, “However, real data transmissions of non-physician approved reports to the CDC was unable to commence, as by the end of this project, the CDC had yet to respond to multiple requests to partner for this activity.”

What do we, the public, take away from this debacle?

As I see it there are only two options.

  1. You give the CDC the benefit of the doubt, assume deep down they have the safety of the public at heart and chalk up their monumental waste of money, time, and a good idea to bureaucratic incompetence.
  2. You stop naively believing that the CDC cares ultimately about public safety and realize that the vaccine industry makes way too much money to allow public confidence in the safety of vaccines to be eroded by a surveillance system capable of giving the public a glimpse of the scope and magnitude of the adverse effects vaccines are actually responsible for.

To assist you in your decision making, I’ll leave you with a statistic from the ICAN (Informed Consent Action Network) request to the HHS to meet the obligations set forth by the 1986 National Childhood Vaccine Safety Act regarding the CDC’s role in the vaccine industry market, “When the CDC recommends a pediatric vaccine for universal use, it creates for that vaccine’s maker a liability free market of 78 million children typically required by law to receive the vaccine.” (emphasis mine)

Ethical Guidelines for Clinical Trials Prevent Many Vaccines From Being Adequately Tested For Safety

The CDC (Centers for Disease Control), the WHO (World Health Organization), the National Institutes of Health (NIH), and the FDA (Food and Drug Administration) are considered by most Americans to be the most credible, trusted sources of “unbiased” information regarding disease, medical treatment, and the safety of pharmaceuticals. Your doctor and the entire medical community base their decisions about your care on recommendations from these organizations, which are theoretically based on the studies brilliant, highly-qualified scientists perform for these organizations. These organizations publicly publish this information so that anyone who wishes to educate themselves can do so.

That is precisely what millions of Americans, including myself, are now doing when it comes to the subject of vaccine safety. Unfortunately we are finding that these “trusted” recommendations are not adding up with the information provided by their own sources and many times are blatantly at odds with this publicly published information. I’m going to clearly demonstrate that to you today.

The focus of this article is the following claim publicly stated by the CDC:

“Before vaccines are approved by the Food and Drug Administration (FDA), they are tested extensively by scientists to ensure they are effective and safe.”

How do scientists test vaccine safety?

There are 3 phases in prelicensure vaccine safety testing as described by the FDA. According to the FDA, “Clinical trials are conducted according to plans that FDA reviews to ensure the highest scientific and ethical standards. The results of the clinical trials are a part of FDA’s evaluation to assess the safety and effectiveness of each vaccine.” Herein lies the rub.

What are the highest scientific standards when it comes to determining safety?

According to the NIH, randomized double blind placebo control studies are the “gold standard.” The NIH goes on to state that, “RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect.”

The problem is, most vaccine studies are not RDBPC due to the ethical standards that must be maintained.

The fact is most vaccine safety clinical trials do not and cannot use a placebo in the truest sense of the word. According to the CDC’s own glossary of terms, a placebo is, “a substance or treatment that has no effect on human beings.” In the case of vaccine testing, a true placebo would have to be an injectable substance that is completely inert, such as saline solution for example. However, that is NOT what is predominantly used in vaccine trials.

If they aren’t using true placebos, what are they using?

According to the 2013 WHO Expert Consultation on the Use of Placebos in Vaccine Trials, the following replacements are used in lieu of a true placebo:

    • “In place of a placebo, a vaccine against a disease that is not the focus of the trial is given to participants who do not receive the trial vaccine.”

Or, an “add-on” vaccine can be used:

    • “In this design, the trial vaccine or placebo product is mixed with an existing vaccine not studied in the trial, and the subjects are given either (a) the trial vaccine mixed with the existing unrelated vaccine or (b) the combination of a placebo and the existing unrelated vaccine.”

Yes, you read those correctly! These vaccines are not being tested for safety against substances that are known to be safe. They are tested against other vaccines which contain the same or similar toxic ingredients common to all vaccines. Some trials are performed using “add-on” vaccines as a placebo. In these cases, potentially everyone in the trial is injected with the actual vaccine being tested! It doesn’t take a rocket scientist to deduce that these methods are unacceptable when the goal is to ascertain safety.

The WHO freely admits this:

“A methodological disadvantage, however, is that trials using these types of placebos provide a less perfect control. It may be difficult or impossible to assess fully the safety and reactogenicity of the trial vaccine, although its efficacy can usually be assessed satisfactorily.” (emphasis mine)

(Reactogenicity is the ability of the vaccine to cause adverse reactions.)

“Methodological disadvantage!?” That’s the understatement of the century!

Let’s look at some very disturbing clinical trial data for a few of the vaccines the CDC recommends. Each vaccine is linked to its package insert so that you can read this information for yourselves:

Engerix B Hepatitis B vaccine (Recombinant) GlaxoSmithKline

“Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines…All subjects were monitored for 4 days post-administration.”

This study doesn’t prove that this vaccine is safe. Plasma derived vaccines were used in the control group instead of a placebo. It demonstrates that this vaccine doesn’t cause any more or any worse adverse effects than other vaccines cause- at least within the 4 day time frame the subjects were monitored.

This vaccine is given to babies on their very first day of life whether they are at risk for Hep B or not. Only babies born to Hep B positive mothers are at risk for Hep B. For millions of babies this vaccine is a completely unnecessary risk that provides them with absolutely zero benefit.

Infanrix (DTaP) GlaxoSmithKline

Table 4, on page 18 shows that Infanrix was not compared to a placebo, it was compared to the whole cell DTP vaccine.

According to WHO, acellular vaccines (like Infanrix) were introduced “to address the adverse reactions observed with whole cell vaccines…” This WHO report also notes that acellular vaccines have replaced whole cell vaccines in industrialized countries. However, due to the increased cost of acellular vaccines, the whole cell is still used in many developing countries. This vaccine is being tested against a control vaccine that we already know to be more dangerous than the type of vaccine being studied!

**Note figure 8.1 on page 18: “Pregnancy Category C Animal reproduction studies have not been conducted with INFANRIX. It is not known whether INFANRIX can cause fetal harm when administered to pregnant women or can affect reproduction capacity.

Despite this information listed in the product packaging, the CDC routinely recommends the DTaP vaccine to pregnant women. You can read about that on the CDC’s website in their article, Pregnant? Get Tdap in your 3rd trimester.

The CDC recommends either the BOOSTRIX vaccine or the Adacel vaccine (both DTaP) to pregnant women. While BOOSTRIX is rated one category safer than Adacel (Category B),the packaging still notes, “A developmental toxicity study has been performed in female rats at a dose approximately 40 times the human dose (on a mL/kg basis) and revealed no evidence of harm to the fetus due to BOOSTRIX. Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well controlled studies in pregnant women. Because animal production studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed.”

Still feeling safe? Still feeling like the CDC has your back?

GARDASIL- Merck

In 7 clinical trials (5 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]- controlled, and 1 uncontrolled), 18,083 individuals were administered GARDASIL or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccine report cards (VRC)- aided surveillance for 14 days after each injection of GARDASIL or AAHS control or saline placebo in these individuals.”

In these Gardasil trials, there actually WAS a control group which was given a true saline placebo. However there was another (much larger) control group given AAHS, which is the adjuvant in the Gardasil vaccine (the toxic portion that triggers immune response.) According to the insert, 15,706 subjects received Gardasil, 13,023 received AAHS and 594 received the placebo. However, they did not compare the three groups separately; they combined the AAHS and placebo group together and compared them to the Gardasil group. This means that the whole Gardasil vaccine was tested primarily against an injection containing its own toxic ingredients and determined to be “safe.”

Furthermore, 40 deaths occurred in the entire study which were broken down by cause. When you subtract the number of deaths that were due to car wrecks, overdoses/suicides and gunshot wounds, and compare the number of subjects who died: 18 subjects who were given either Gardasil or AAHS died and only 1 who had been given the placebo died.  Think about that! Subjects who received Gardasil or AAHS instead of placebo, died at a rate of 18 to 1!

Why Don’t Scientists Use Appropriate Placebos in Trials?

The “gold standard” in clinical trials cannot be implemented because the use of a placebo in many cases is unethical. The purpose of the 2013 WHO Expert Consultation on the Use of Placebos in Vaccine Trials was to detail the guidelines placed on the ethical use of placebos in vaccine trials. If using a traditional, inert placebo in the control group doesn’t “add any risk of serious or irreversible harm,” then clearly there is nothing unethical about using it. But what about when it does?

For example, according to WHO reports, in 2008 rotavirus was responsible for about 5% of all child deaths globally, with 90% of these deaths occurring in Africa and Asia. In a 2011-12 clinical trial in India for a new rotavirus vaccine, 2/3 of the infants received the test vaccine while 1/3 got a saline placebo injection. At the time, two approved oral rotavirus vaccines were already available. Not giving 1/3 of the Indian children in the trial a vaccine already known to be effective against rotavirus, constituted a human research violation that would not have been allowed in the US. Allowing preventable harm to occur in the name of research is unethical.

This means, for very legitimate ethical reasons, using true placebos according to the “gold standard” of clinical testing is not feasible. However, this in no way negates the fact that due to ethical constraints, it is impossible to accurately assess vaccine safety in many cases. It is also unethical to fail to provide this information to parents when discussing vaccine safety.

It crosses the line of unethical and meanders into the territory of illegal, when this information is intentionally censored from vaccine education sheets given to parents in the pediatrician’s office (as well as from conversations with your pediatrician) assuring that vaccines are “extensively tested for safety” knowing full well that safety and reactogenicity are “difficult or impossible to assess” by their own publicly published standards.

The next time someone tells you that vaccines have been proven safe in numerous extensive studies you can tell them that information is blatantly false, and the CDC, WHO, NIH, and FDA know it. Vaccines cannot be both adequately and ethically tested for safety.