According to a well-known story in the scientific community, an elderly woman approached a famous scientist shortly after he concluded his lecture on cosmology and the structure of the solar system:

“Your beautiful theory about the earth being round, and rotating around the sun, is very interesting, young man. Unfortunately, it is also very wrong. I have a better theory,” the woman told him.

“And what would that theory be, madam?” the scientist responded.

“Well, what you call ‘planet Earth’ is not round at all. Actually, it is kind of a large, flat disk that rests on the shoulders of four giant elephants.”

“And what do these four elephants stand on?” the scientist inquired.

“They stand on the back of a giant turtle,” the elderly woman answered.

“And what does that turtle stand on?” the scientist asked with an inquisitive grin.

“On another, bigger, turtle.”

“And what does the second turtle stand on?”

“Well, my dear man,” said the elderly woman with a victorious smile, “it’s turtles all the way down!”

Even today, approximately 150 years after it first appeared, the story of the scientist, the elderly woman, and the turtles remains quite popular in scientific circles. Its appeal appears to be due not only to the paradoxical punchline, but also to the way it portrays the relationship between scientists and laypeople: On the one hand, the wise scientist, rational and calm, and on the other the simple-minded elderly woman confusing scientific knowledge and reality with myth. By emphasizing the wide intellectual chasm between expert and layperson, this amusing anecdote reinforces scientists’ deep-seated expectation that science be unanimously recognized as the arbiter of objective Truth. Standing on their high pedestal, scientists, at least in their own eyes, are both worthy and capable of making final judgments on matters of public interest related to their expertise.

This paternalistic tendency is evident in long-standing attempts by scientific and medical entities to portray the public conversation on vaccines as a lopsided dispute. On one side of the debate, we are told, stand doctors and researchers who draw their moral authority from years of academic training and work experience and whose arguments are backed by solid scientific evidence and validated by the medical establishment worldwide. On the other side, they tell us, stand a multitude of parents and activists, who lack formal training, follow charlatans and quack doctors, and feed on fake news spread through social media.

Yet, as will become clear in the following pages, the surprising truth – which becomes self-evident when one devotes enough time and energy to researching vaccines – is that the roles are reversed: The elderly woman (the parents in this case) anchors her claims on bedrock science and displays a deep understanding of scientific methodology, while the medical establishment bases its position on… “turtles all the way down”.

Vaccine safety lies at the heart of the long-lasting and intense clash between those that support universal vaccination and those that oppose it. Health authorities’ argument that Vaccines are safe! is based, first and foremost, on the presumption that each new vaccine undergoes a meticulous process of testing and approval. This process includes a series of clinical trials, which purportedly utilize the most advanced scientific tools and techniques available and adhere to the highest safety standards. Once a new vaccine successfully passes these hurdles, it is considered safe by all relevant medical bodies.

This chapter, then, examines the methodology used for testing vaccines’ safety as part of their pre-licensing approval process. Are new vaccines really rigorously scrutinized, as the public is routinely promised, in keeping with an uncompromising commitment to the highest possible safety standards?

Not only is the answer a flat “no”, by the end of this chapter you will learn the inconceivable secret the medical establishment has concealed from the public eye for decades: Clinical trials of vaccines are rigged to hide their true (and high) rate of side effects, which means the medical establishment’s longstanding claim that vaccines are safe has no scientific merit.

It sounds improbable, doesn’t it? Impossible to believe!

By the time you finish reading this chapter you will know it’s true.

Before we explore the methods employed by medical authorities to conceal vaccines’ inadequate safety testing, we must familiarize ourselves with their pre-licensing approval process and its principal tool – the randomized controlled trial. Armed with this knowledge, we can then peel off, one by one, the protective layers that enfold the hidden, abhorrent, and nearly unbelievable truth.

Medical “biologics” (such as vaccines) undergo a lengthy and tedious approval process, replete with bureaucratic forms, documents, and reviews. The process is determined by the authorizing body – most commonly the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) – and includes, in addition to endless paperwork, a requirement to conduct a series of clinical trials^[b] that demonstrate the effectiveness and safety of the product submitted for approval. This required series of clinical trials is divided into three phases, with each phase commencing only when and if the preceding phase has been successfully concluded. If the product does not prove safe or effective in any one of the phases, it will not win the coveted approval. Consequently, its development is likely to terminate, and the (usually considerable) funds invested in it will go down the drain.¹

The first hurdle a new vaccine must leap is the “pre-clinical phase”, in which the product goes through a multitude of laboratory^[c] and animal experiments.

The next step in the series is a Phase 1 Clinical Trial, in which a small trial group (typically dozens of subjects) is given the new vaccine in order to determine how the human body responds to it. The underlying assumption is that, despite its success in animal experiments during the pre-clinical phase, the vaccine could still prove to be harmful to humans.² Therefore, in this stage, researchers attempt to identify particularly salient or severe side effects, such as severe allergic reactions, disability, early symptoms of a chronic problem, severe illness, or death. Due to the limited number of subjects, a Phase 1 trial cannot provide a complete picture of the extent and variety of side effects (adverse events) that could potentially be caused by the vaccine.

If the vaccine successfully passes Phase 1, the next experimental phase – the Phase 2 Clinical Trial – is performed on a larger group, typically several hundred people, and the vaccine’s effectiveness is evaluated in its designated population (e.g., adults over 65 or diabetic patients under 18). This stage is also when the effects of varying the vaccine’s dosage and delivery timing on efficacy and safety are examined. However, the absence of a control group (see the Randomized Controlled Trial section below) and the relatively small number of subjects in Phase 2 trials, preclude the attainment of definite or final answers regarding the vaccine’s efficacy and safety. Those await the next testing phase.

Phase 3 Clinical Trials are conducted in several thousand subjects, sometimes even tens of thousands. These trials are designed to assess and validate the vaccine’s effectiveness, to compare the new treatment with existing treatments (if any), and to collect information that will allow the vaccine to be used safely. This is the final experimental phase before the approval for commercial use, and it is of paramount importance in determining the efficacy and safety of the experimental vaccine. Phase 3 results will be published in the manufacturer’s package insert and will serve as key evidence for the vaccine’s safety and efficacy for years to come.

Subjects in a Phase 3 trial are randomly divided into one of two groups: the trial group, which receives the test vaccine over a specified period of time, and the control group, which receives a placebo (dummy) or some other compound (see the detailed explanation in the next section). Throughout the study period, researchers monitor trial participants’ health and collect information that will be used to evaluate the vaccine’s efficacy and safety. The large quantity of subjects, as well as their separation into trial and control groups, affords a deeper probe into the vaccine’s safety and its potential side effects, including those that occur relatively infrequently (i.e. one case in hundreds or thousands of subjects).

Successful completion of a Phase 3 trial paves the way for the long-awaited approval for commercial production and marketing of the new vaccine. However, even after the vaccine has been in general use for a while, additional trials are sometimes called for. These “post-marketing” trials may be required to investigate unexpected adverse events reported after licensing or negative effects that have emerged in a specific population segment. This type of trial is called a Phase 4 Clinical Trial.

As mentioned above, after the vaccine successfully passes Phase 3 trials, the doors open for commercial use. However, for new vaccines, receiving approval from the authorizing body is not sufficient. The product must also receive the approval of the authority responsible for distribution of vaccines. In the US, the FDA is in charge of licensing new vaccines, while the Centers for Disease Control and Prevention (CDC) is responsible for making recommendations for their actual use, including who should receive them (their ages and health status), the timing and number of doses to be received, and which vaccines can be given concurrently. The final step in the long process of marketing a new vaccine is its integration into the national vaccine programs of the US and other countries around the globe. Adding a vaccine to the American schedule recommended by the CDC instantly guarantees sales of millions of units per year in the US alone, thus assuring its manufacturer a handsome return on its initial investment.³

In a “simple” vaccine clinical trial (one without a control group, as is the case for trials in Phases 1 and 2), researchers face an inherent difficulty in determining whether a specific condition reported during the trial period is actually caused by the experimental compound or not. If a trial subject experiences a severe and immediate phenomenon following the receipt of the test vaccine, such as fainting or cardiac arrest, it could be reasonably assumed that the recently consumed vaccine was the culprit. When the side effect is less pronounced, or appears days or weeks following vaccine administration, however, the researchers’ decision is less obvious. For example, if the subject’s temperature rises to 103°F less than 48 hours after administration of the test vaccine, the researchers do not have enough information to decide whether this is a true side effect or merely an unfortunate coincidence. One option is to have every participant who experiences a health-related condition during the trial undergo a series of in-depth medical examinations in order to uncover possible links to the experimental vaccine. This strategy is not feasible or economical, however, if only because the vaccine is new and its specific effect on the human body is virtually unknown. Consequently, such an investigation could prove lengthy, costly, and unlikely to yield conclusive results.

A better option is to conduct an “enhanced” clinical trial – a controlled, randomized, and blinded trial (also known as a randomized controlled trial – RCT). In an RCT, subjects are divided into two groups:^[d] the trial group, receiving the test compound, and a control group, receiving a dummy or existing compound (whose efficacy and safety profile is well known). Subjects are randomly assigned to the two groups prior to the start of the trial to ensure that the groups are virtually alike in every relevant characteristic (age, gender, area of residence, demographic status, and so on). The term blinded (or blinding), means that the trial subjects do not know which group they are in and thus do not know whether they received the test or dummy compound. In a double blind trial, the researchers also do not know which subjects belong to which group. Thus, prior knowledge of which compound a participant received is not likely to influence either subjects or researchers and skew the results of the trial. In a non-blinded trial, subjects who receive the test compound, rather than the dummy one, may complain more about side effects, since they expect them to occur.^[e] Similarly, a researcher who knows a particular subject belongs to the control group also knows that any reported side effects are not due to the vaccine and may inadvertently (subconsciously) underreport medical conditions occurring during the trial period. Only when the trial is over, after all relevant information has been collected, is the specific compound administered to each of the study subjects revealed, and the researchers, with the complete data in hand, can begin the post-clinical data analysis.

When it comes to pre-licensure testing of drugs, vaccines, and other medical products, RCTs are widely considered the industry’s “gold standard”. The random distribution of subjects to trial and control groups, as well as the minimization of potential biases through the use of double-blinding, facilitates a reliable and meaningful comparison of trial and control group data.⁴ As an example, in a vaccine trial in which the control group is receiving a dummy compound, one can measure the level of antibodies produced in trial group subjects and compare it to that of the control group, thus getting a measure of vaccine efficacy. Similarly, a researcher could compare the incidence of adverse events following vaccination in the two groups, thus getting an estimation of vaccine safety. The larger the number of trial participants and the better the researchers adhere to RCT standard practices, the more reliable and comprehensive the trial results will be.

Due to the high quality and reliability of RCTs, they are the method designated by regulatory agencies (and accepted by the pharmaceutical industry) for evaluating efficacy and safety of vaccines in Phase 3 clinical trials.⁵

As we have seen, the use of a control group in a clinical trial allows researchers to examine the therapeutic effect of the compound (efficacy) and the rate of adverse events it causes (safety) by comparing outcomes in the trial group with those of the control group. This comparative statistical analysis, then, will be influenced by the nature of the compound the researchers give to the control group.

As a general rule, when deciding upon the type of compound given to the control group in an RCT, there are two options. For a trial of a completely new drug or vaccine, i.e. one which does not have an approved equivalent, the control group should receive an inert compound (placebo)⁶ that does not affect the parameters measured in the trial.^[f] However, if a proven treatment already exists, it may be unethical to prevent control group participants from receiving it. For example, in trials of new cancer drugs, it is considered unethical to prevent the control group’s subjects from receiving an existing drug for their illness. In this scenario, then, the control group would receive the current approved treatment. This practice is also the norm for vaccines even though vaccines are used preventatively (not treatment for an existing condition) and are given to healthy individuals.⁷

If we apply the above guidelines to the clinical trials for the two generations of the Prevnar vaccine,^[g] then the original Prevnar, a new vaccine that had no therapeutic alternative at the time it was developed, should have been tested in an RCT in which the control group received an inert injection as a placebo. In the trials of Prevnar-13, the next-generation vaccine, the control group should have received the (original) Prevnar vaccine, assuming that it would be unethical to deprive that group’s subjects of the current Prevnar vaccine’s protection, whose efficacy is already proven.

So how do researchers determine the incidence of adverse events associated with the new compound being tested in a controlled clinical trial? By comparing the rate of adverse events observed in the trial group to that of the control group. For example, if in a new vaccine’s trial group of 1,000 infants there were 20 cases of high fever, and in the control group (which has the same number of subjects) there were only 10 such cases registered, the results would imply the risk of high fever in the vaccinated is twice as high as in the unvaccinated. In absolute terms, the data shows that the vaccine increases the risk of high fever occurrence from 1 in every 100 infants to 1 in 50.^[h]

When the control group’s subjects are given a placebo, an inert substance not known to cause high fever, it is assumed that the incidence of high fever recorded for the group represents the background rate (or baseline rate) of the phenomenon. In other words, the background rate is the number of subjects who would experience high fever naturally, regardless of any trial intervention. In our example above, we would assume that 1 in 100 control group subjects developed high fever due to random causes (unrelated to the trial). Since the trial group would likely experience a similar background rate of high fever (1 in 100), any significant deviation from this level should be attributed to the experimental vaccine. It follows, then, that an RCT in which the control group receives an inert placebo is designed to answer the critical question of How many adverse events does the new vaccine cause? Of course, we should keep in mind that trial results are no more than a good estimation. If or when the vaccine is released to the market, the actual reported adverse event rate might deviate significantly from that observed in the clinical trial. Still, the results of RCTs are the best estimate of safety available to science during the vaccine approval process, and in many cases, throughout its lifetime.

In a trial in which the control group receives a different vaccine (as in the trial of Prevnar-13 vs. Prevnar, its predecessor), the results obtained are always relative, answering the question How many more (or less) adverse events does the new vaccine cause compared to the current vaccine? For example, if (out of 1,000 subjects) 24 cases of high fever were observed in the trial group, while 20 such cases were reported in the control group, the new vaccine would appear to increase the odds of high fever by 20% (relative to the current vaccine). That is an important piece of information as it reveals how the new-generation vaccine’s safety fares against that of its predecessor. However, it is impossible to calculate from a trial such as this one the absolute rate of adverse events caused by the experimental vaccine – that is, the rate of adverse events from vaccinating compared to not vaccinating. The absolute rate could not be calculated because the control group received a compound (the current vaccine) which is not inert (neutral), but rather has side effects of its own. In the above example, 24 cases of high fever were observed in recipients of the new vaccine, and 20 cases in current vaccine recipients. But how many cases would have been reported in trial subjects given a true placebo? This trial cannot answer that question; therefore, the absolute rate of adverse events caused by the new vaccine cannot be calculated from trial data. The new vaccine could be said to cause 24 cases of high fever per 1,000 subjects, but this number would not represent a reliable estimate^[i] as it does not take into account the background rate of the phenomenon, which was not measured in the trial.

In order to determine the true rate of adverse events of a new generation vaccine, a three-arm trial must be conducted, combining the two methods described above. In this kind of trial, subjects would be randomly allocated into three groups, one trial and two controls: The trial group would receive the new generation vaccine, the first control group would receive the current vaccine, and the second control group would receive an inert placebo. This trial design is considered to be of excellent quality, as it measures both the absolute rate of adverse events (comparing the new vaccine to the placebo) and the relative rate (comparing the new vaccine to the current vaccine).⁸ From a public health perspective, the three-arm trial answers two important questions: (1) How many adverse events does the new vaccine cause when compared to not vaccinating? and (2) How many adverse events does the new vaccine cause when compared to the existing vaccine?^[j] Continuing with our Prevnar example, if the placebo-receiving control group reported, say, 8 high fever cases per 1,000 subjects, then the study would indicate that the new vaccine – which, as we recall, had 24 cases of high fever per 1,000 subjects – increased the risk of high fever by a factor of three (or, put differently, caused 16 more cases per 1,000 subjects), compared to not vaccinating.

Another scenario in which a three-arm trial would be appropriate is re-establishing the safety of a legacy vaccine that was originally tested many years ago. The environment into which today’s infants are born may differ significantly in crucial health-related aspects from the environment in which a first-generation vaccine was tested decades ago. For example, the current measles-mumps-rubella-varicella (MMRV) vaccine (ProQuad) is the “grandchild” of the original MMR vaccine, which was tested in the late 1960s. Back then, the vaccine schedule consisted of only the diphtheria-pertussis-tetanus (DPT) and polio vaccines, with the first dose administered at age two months. If ProQuad were clinically tested against the original MMR and proved to have a similar safety profile, could we assume it is safe just because its grandparent vaccine was deemed safe 50 years ago? MMR vaccines are typically administered in the second year of life, after most of the infant vaccine schedule has already been delivered. If, hypothetically, the MMR’s risk of harmful side effects were related to the load of previously administered vaccines, then we could not automatically accept the present safety of the original MMR. Remember that the MMR was first tested when the vaccine schedule consisted of only two other vaccines. If it were tested today, with many more vaccines on the schedule, some of which are given to pregnant mothers, others to newborns and infants one month of age, would it still be proven safe? And the changing vaccine program is just one aspect of the environment that may affect the safety of a given vaccine. Other factors, such as chemical exposure, changing diets, air pollution, radiation, etc., could also play a role. Therefore, a clinical trial comparing ProQuad to MMR alone is deficient, as it would rely on the presumed safety of a vaccine (MMR) that might no longer be safe. Once more, a third group receiving a placebo is the proper solution to the problem.^[k]

To summarize, in a clinical trial of an (entirely) new vaccine, the control group should receive a placebo so that the absolute rate of the vaccine’s adverse events can be determined. This design does not pose an ethical problem, since the vaccine has no existing alternative. In a trial of a new-generation vaccine, one control group should receive the current vaccine and another should receive a placebo (a three-arm trial).

Another important point to consider is that an RCT control group cannot be replaced with data from another trial, or any other externally calculated background rate. In other words, it is not scientifically valid to draw conclusions by comparing the observed rate of any phenomenon in a randomized controlled trial to the rate reported in another trial or to a rate observed in the general population.^[l] For example, if in a particular vaccine trial the reported incidence of sudden infant death syndrome (SIDS or “crib death”)^[m] in the trial group were 0.5% (1 in 200), researchers could not then compare this rate to the background rate of the phenomenon in the population (say 0.8%), thus determining that the vaccine lowered the risk of SIDS. This is because trial participants comprise a subgroup which could possess specific characteristics, known or unknown, which are not representative of the entire population. This could potentially yield trial results that are not comparable to rates in the general population.⁹ For example, the proportion of infants participating in a trial whose parents smoke may be much lower than the background rate in the entire population, skewing the incidence of crib death in trial participants in a downward direction. Of course, skewing in the opposite direction is equally possible.

Similarly, there is little scientific merit in comparing results from different clinical trials. For example, no significant insights could be derived from comparing the results of a Prevnar-13 trial carried out in infants from the New York area in 2010 with those of a Prevnar trial conducted in Philadelphia in 2005. This is due to the randomization principle of the Randomized Controlled Trial (RCT), which requires that the trial participants be randomly divided between the trial group and the control group. Obviously, groups whose members were selected at different times and places would not satisfy this requirement. In the above examples, any differences in trial results could be entirely due to dissimilarities between the groups, such as different socioeconomic status, environmental exposures, or behavioral characteristics.

The principle described above is well known to the pharmaceutical industry and it appears in numerous vaccine manufacturers’ leaflets. For example, the package insert for Glaxo-Smith-Kline’s (GSK) hepatitis A vaccine (Havrix) reads: “Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.”¹⁰

Throughout most of the 20th century, the prevailing opinion in the world of medicine was that due to the relative fragility of children (compared to adults), they should be protected from the perils of medical research. The result was a distinct lack of scientific knowledge about the effects of medical interventions (such as medication) on children. Administering medication to children, therefore, was largely a wide-ranging experiment conducted on the public. Circumstances began to change in 1977 when the American Academy of Pediatrics (AAP) published new guidelines regulating the participation of children in clinical trials. In the new guidelines, the AAP said that drugs and vaccines should be tested on the population for which they are intended – in this case, children – and that this requirement is not only ethical, but essential to their health as well.¹¹

Over the following decades, various international medical organizations have formulated ethical rules governing the participation of children in clinical trials of drugs and vaccines. According to these rules, children may only be included in experiments intended to achieve an important scientific or public health objective directly related to the health and well-being of children. Children should not participate in studies that do not promote such goals, such as studies designed merely to confirm the results of other studies or studies designed to advance scientific knowledge that does not concern children.¹²

In addition, the medical code of ethics states that all parties involved in a trial must carefully weigh the potential benefit to child participants against the potential dangers involved. If the study’s participants cannot be expected to benefit from the given intervention, then the intervention’s inherent risk must be “minimal”, especially if the subject has not consented to participate in the trial (as is the case with infants). For example, if children assigned to the control group of a drug trial were to receive a dummy medication (placebo) and a blood test, then both the medication and the blood draw must present no more than “minimal” risk. Also, the potential benefit must be substantial enough to justify the intervention’s risk.¹³ For example, in a trial of a children’s cough syrup, the risk associated with the new drug should be relatively low as the potential benefit would be relatively low, while the potential benefit in a trial of a child cancer medication would be significantly higher, thus the risk posed by the drug could be proportionately higher as well.

A more lenient approach holds that even if a trial procedure has no expected benefit, a “minor increase over minimal risk” is allowed if the experiment has the potential for gaining knowledge about the subjects’ disorder that is considered to be of “vital importance”. However, even with this approach, the risk associated with the intervention must not exceed the risk a healthy child would face in everyday life and should not cause permanent or irreparable damage. In any case, there must be prior knowledge of the level of risk inherent in the procedure. If the risk is unknown, it cannot be determined to be “a minor increase over minimal risk”.¹⁴ It is important to note that the above discussion holds equally true for both the trial and control groups of an experiment.

Now that we are familiar with the different clinical phases of the vaccine approval process, the purpose of control groups in randomized controlled trials, and the ethical limitations imposed on children’s participation in medical research, we can better examine the deliberately flawed procedure the industry uses to conduct vaccine clinical trials.

Let’s take a moment to examine a hypothetical scenario: A major pharmaceutical company has developed a new drug against a particular medical problem. Following its preliminary trials, the company realizes that the drug is associated with a relatively high incidence of serious side effects that may negatively affect its chances to win FDA approval. Let us suppose that, since the company spent hundreds of millions of dollars developing the drug and the target market segment is worth billions of dollars in sales per year, the company decides to move forward with the licensing process and start a Phase 3 clinical trial. Given all of the above, what are the company’s options, legal and illegal, for ensuring that the trial demonstrates a positive safety profile, thus clearing the way for the drug’s approval?

One option is to artificially lower the incidence of adverse events reported in the trial group (the group receiving the new drug), by withholding or modifying data for specific cases. The difficulty with this technique is that for the duration of the trial, because of the enforced double-blinding, researchers do not know which subjects belong to which trial group. Thus, one cannot suppress or dilute reports for a specific group (the trial group, in this case) while leaving those of the other intact. Randomly suppressing reports would not be likely to accomplish the desired effect as the ratio of adverse events in each of the two groups would probably not change much.

Another theoretical option would be to modify the results following the conclusion of the clinical stage of the trial, at which point the blinding is removed and the data becomes fully available to the researchers.^[n] The difficulty with this approach is that falsifying trial data is a criminal offense, which can lead to grave consequences for the company and the researchers themselves, making this an unattractive option.

Another option would be to use various statistical techniques (which will be discussed later in the book), to build a false safety profile for the drug being tested. The difficulty with this approach is that the RCT study design greatly reduces researchers’ ability to affect the results since they gain access to the full data set at a time when the data can no longer be altered. With limited ability to control the data, it can be quite difficult to eliminate undesired signals by statistical manipulation while at the same time successfully covering one’s tracks.

The last option available to the company wishing to hide their product’s undesirable side effects is to design a trial in which the reported rate of adverse events in the control group would likely be very similar to that of the trial group. As described previously, the RCT’s control group represents the baseline rate to which the trial group is compared. A similar proportion between the two groups would indicate that the adverse events reported in the trial group were the result of “background noise” only and not caused by the experimental drug. This technique has three distinct advantages: (1) It is 100% legal, (2) it is very effective, and, as it turns out, (3) it has the full approval of licensing authorities around the world. As we shall shortly see, this method is exactly the one vaccine manufacturers employ to deliberately obscure the real incidence of vaccine adverse events.

The entire vaccine program is founded upon this deception.

It is virtually impossible to state the bottom line of the analysis presented above mildly, so here goes: Vaccine trials in general, and childhood vaccine trials specifically, are purposely designed to obscure the true incidence of adverse events of the vaccine being tested.

How do they do this? By using a two-step scheme: First, a new vaccine (one which does not have a predecessor), is always tested in a Phase 3 RCT in which the control group receives another vaccine (or a compound very similar to the experimental vaccine, see explanation below). A new pediatric vaccine is never tested during its formal approval process against a neutral solution (placebo). Comparing a trial group to a control group that was given a compound that is likely to cause a similar rate of adverse events facilitates the formation of a false safety profile. The rate of adverse events of the tested vaccine is said to be similar to the “background rate”, hence it is considered safe. The researchers, and the vaccine manufacturer they work for, seem to “forget” that the compound they administered to the control group is a bioactive substance, carrying its own risks and side effects, and hardly represents the baseline or background rate that is essential to an RCT for a new vaccine.

Thus, the vaccine is approved and added to national vaccine programs throughout the world. Then, when the “next generation” vaccine comes along, its pre-licensing clinical trials will always compare the new vaccine to the current vaccine and never to a placebo. Thus, all parties involved ensure that the true rate of vaccine adverse events is never discovered – for either the original or upgraded vaccine – and that rate is never shared with the public, or even the medical world.

The practice of giving a different vaccine to the control group in an RCT of an entirely new vaccine and calling it “placebo” is a deliberate misrepresentation of the term. As explained previously, a placebo is a compound (or procedure) that does not affect the parameters measured in the trial. When testing the efficacy of a new vaccine, researchers measure the level of disease antibodies in both study groups, so the substance given to the control group must not affect that antibody level, or the comparison becomes meaningless. For example, in a hypothetical new hepatitis C vaccine trial, it would not make scientific sense to inject the control group subjects with a compound that could increase (or decrease) the subjects’ hepatitis C antibodies. Doing so would preclude a valid assessment of the effect of the vaccine on the antibody level, as the substance taken by the controls could have distorted the comparison.^[o]

The above analysis holds true for safety testing as well. If the compound given to the control group has its own significant side effects, it cannot be regarded as a true placebo. If the rates of adverse events observed in the trial and control groups appear similar, is it because the experimental vaccine is safe or because the control compound is just as unsafe as the vaccine? It would be impossible to know. Giving the control group an active substance in an RCT intended to test safety would be a bad design decision, then. Yet this is exactly how new vaccine Phase 3 trials are performed: Instead of a placebo, the control group receives a different vaccine, which is certain to cause its own adverse events and can in no way be deemed a neutral substance.

This practice of administering a different vaccine to the control group in a new-vaccine trial has no bearing on efficacy testing: It is highly likely that the control vaccine, which usually targets a different disease, would have no effect on the antibody level of the disease targeted by the test vaccine. Thus, using our hepatitis C example, if the control group subjects in the vaccine trial were given the Prevnar vaccine, no change in their hepatitis C antibody level would be expected; thus, the true efficacy of the test vaccine could be determined. But this lack of effect is not the case when it comes to safety: Because the Prevnar vaccine has its own side effects, it cannot be considered neutral in this context. Therefore, the true rate of adverse events for the experimental hepatitis C vaccine cannot be determined by comparing it to the rate in the group that received Prevnar since the controls did not receive a neutral compound.

This deliberate distortion of the placebo concept in clinical trials of new vaccines is so prevalent that researchers and vaccine package inserts frequently refer to the bioactive compound given to a control group as “placebo”, even when it’s clear it is another vaccine or a similar bioactive compound, which in itself is not safety-neutral.¹⁵ Falsely using the term “placebo” allows researchers to conclude that the new compound “was proven safe” because its rate of adverse events was similar to that of placebo – even though the substance the control group received was decidedly not a placebo. For example, in one of the DTaP^[p] vaccine trials, the rate of hospital admissions in the trial group was almost 1 in every 22 subjects. The researchers did not consider this statistic alarming, however, because in the control groups that received different DTP vaccines,^[q] the hospitalization rate was similar.¹⁶ Was such a high hospitalization rate in trial participants unrelated to the vaccines used, or were they the main culprit? Only the use of a true placebo control group could answer that question.¹⁷

No logical explanation can be found for the ubiquitous practice of administering bioactive compounds to control groups in trials of new vaccines other than a desire to conceal the true rate of adverse events of the vaccine. Testing a new vaccine against a placebo in an RCT is the simplest, safest, cheapest and most reliable option. Saline (sterilized salt water), for example, is a safe, reliable, widely available, and inexpensive compound – certainly when compared to a vaccine. Because it does not cause significant adverse events, nor does it produce disease-specific antibodies, it provides a reliable baseline for both safety and efficacy testing and is therefore ideal for control group usage. Calculation of the true rate of adverse events of the test vaccine becomes straightforward and simple. Despite its clear benefits as a placebo, vaccine makers prefer not to use saline in vaccine trials, and the reason for this should be obvious by now.

Now that the groundwork has been laid, it’s time to consider the vaccines on the CDC’s recommended childhood vaccine schedule: How were they tested for safety before getting marketing approval? Were the clinical trials of these vaccines “cooked” in the manner described above? Were they tested against (real) placebos? Is their true rate of adverse events known?

According to the current CDC vaccination program,¹⁸ all children routinely receive vaccines against 13 different diseases by the age of two years.^[r] Let’s examine each of these vaccines.

Diphtheria-Tetanus-acellular-Pertussis Vaccines (DTaP): The DTaP vaccine is administered in various combinations – with or without inactivated polio, Hib, and hepatitis B components – and is manufactured by two companies: GlaxoSmithKline (GSK) and Sanofi Pasteur.

GSK’s Pediarix vaccine protects against five diseases: diphtheria, tetanus, pertussis, hepatitis B, and polio. The safety section of the vaccine’s package insert mentions 14 clinical trials involving 8,088 subjects. In the largest of the trials, conducted in Germany, the trial group received the Pediarix vaccine and a Hib vaccine, while the control group received Infanrix (DTaP vaccine, see below), Hib, and oral polio vaccines. In another trial explicitly mentioned in the leaflet, Pediarix was tested against a control group receiving Infanrix, hepatitis B, and inactivated polio vaccines. The leaflet does not describe the compounds given to the control groups in the remaining 12 safety studies, other than indicating that all of them received “comparator vaccines”.¹⁹

GSK also manufactures a 4-in-1 vaccine called Kinrix, which is identical to the above Pediarix, minus the hepatitis B component. In the vaccine’s largest clinical trial, the control group received Infanrix and IPOL (polio) vaccines. All trial participants were also concomitantly administered a dose of the MMR vaccine. The leaflet does not mention any trial involving a placebo control group.²⁰

And how was the aforementioned Infanrix vaccine itself tested? The vaccine, which includes diphtheria, tetanus, and acellular pertussis components, was tested for safety in one clinical trial against a control group that received the DTP vaccine (the older, whole-cell pertussis, version), and in another that had no control group.²¹

What about the older generation DTP vaccine? What safety testing did it undergo? Although this vaccine is known to have caused serious side effects in infants (and was therefore replaced by the newer DTaP vaccine in the late 1990s),²² it was never tested in a modern clinical trial in which the control group received a true placebo.²³ The vaccine, which was developed in the first half of 20th century, underwent a series of trials in the 1930s and 1940s at a time when the concept of the randomized controlled trial was still in its infancy. Hence, in most of these trials, there was no randomized control group, and the researchers devoted little effort to gathering information on the side effects of the tested vaccine.²⁴

In addition to the above, a search of the clinicaltrials.gov web-site, a repository of clinical trials conducted since the year 2000, yields dozens of results for GSK’s Infanrix vaccine family. None of them specifies an RCT with a placebo control group.²⁵

To summarize, the safety of GSK’s 5-in-1 and 4-in-1 vaccines was tested against the triple vaccine (DTaP), which was tested against the older generation vaccine (DTP), whose safety was never tested in an RCT with a placebo control group. A turtle standing on the back of a turtle, standing on the back of yet another turtle – all the way down.

In addition to GSK’s diphtheria-tetanus-pertussis family of vaccines reviewed above, Sanofi Pasteur’s DTaP line of vaccines is also approved for use in the US. The Pentacel vaccine (DTaP, polio and Hib) was tested in four clinical trials during its licensing process. In three of the trials, the control group participants received an assortment of different vaccines.²⁶ The fourth trial appears to have had a control group that received no vaccines. However, the clinical review document submitted to the FDA reveals that the trial actually had no control group.²⁷

Sanofi’s Quadracel 4-in-1 vaccine (DTaP and polio) was tested for safety in one large clinical trial. The control group received Sanofi’s 3-in-1 (Daptacel) and polio vaccines.²⁸

Daptacel, Sanofi’s triple DTaP vaccine, underwent four clinical trials during its licensing process. All of the trials were randomized and controlled, and in all of them, the control group received different combinations of DTaP or DTP vaccines, sometimes concurrently with other vaccines as well.²⁹

The rates of adverse events in the trials reviewed above were always compared with rates observed in control groups whose participants also received vaccines. For example, a major study conducted in Sweden in the early 1990s compared four different DTP-related vaccines and found that serious adverse events – seizures, life-threatening events, onset of chronic illness, and more – occurred in approximately 1 in 200 vaccinees. Adverse events classified as “prohibiting future vaccination” were reported for 1 in every 100 vaccinees, and about 1 in 22 subjects were admitted to a hospital.³⁰ However, since the rates for the new-generation-vaccine (DTaP) groups were similar to that of the old-generation-vaccine (DTP) groups, the new vaccines received the green light.

The bottom line is that none of the many products in either of the DTaP vaccine family lines routinely administered in the US has been tested for safety in a clinical trial with a placebo-controlled group.

Haemophilus Influenzae Type B (Hib) Vaccine: The vaccine protects against infection caused by the Haemophilus influenzae type b bacterium. It can be administered as a component of the 5-in-1 Pentacel vaccine, discussed above, or as a separate vaccine. At present, there are three standalone Hib vaccine brands approved for use in the United States.

Hiberix is produced by GSK. Its package insert reports a single RCT in which the vaccine was administered concomitantly with several other vaccines (DTaP, polio, hepatitis B, and others). The two control groups received a different Hib vaccine or a DTaP-polio-Hib vaccine, along with several other vaccines. Seven other trials mentioned in the leaflet were not blinded (“open label”) and apparently had no control groups.³¹

ActHIB, manufactured by Sanofi Pasteur, was clinically tested for safety in three RCTs. In the first, the vaccine was simultaneously administered with the DTP vaccine, while the control group received the DTP vaccine alone. In the other two trials, the trial groups received a combination vaccine with ActHIB as one of its components, while the control groups received the same combination vaccine (without the ActHIB component), and a separate ActHIB vaccine.³²

PedvaxHIB, by Merck, was tested in Native American infants. The package insert states that the control group received a placebo; however, all trial participants were also given the DTP and OPV vaccines concomitantly.³³

Polio Vaccine (IPV): Similar to the Hib vaccine, the inactivated polio vaccine is administered as either a component of DTaP combination vaccines (discussed previously) or as a standalone vaccine. The IPOL vaccine, by Sanofi Pasteur, is the only brand currently licensed and used in the United States. Its package insert does not mention any pre-licensure RCTs that were performed for the vaccine.³⁴ Wasn’t the vaccine clinically tested before it was introduced into the US schedule in the early 1990s?

Well, no. According to a document released by the FDA in 2018 following a Freedom of Information Act (FOIA) request, the vaccine underwent two clinical trials. However, these trials did not meet the current requirements for a Phase 3 randomized controlled trial. The first trial, which was conducted in 1980-1983, consisted of only 371 subjects in the IPOL trial group and about the same number in the control group, which (and this shouldn’t be surprising by now) received the oral polio vaccine (OPV). The OPV, manufactured by Lederle, was the only polio vaccine licensed in the US at the time. In addition, all trial participants received the DPT vaccine. The trial was controlled, randomized, and possibly blinded (though the licensing documents do not state this explicitly), but obviously not placebo bound. The second study, conducted in Buffalo, New York, in the late 1980s, enrolled 114 children who underwent a series of three vaccinations with either IPOL, OPV, or a combination of both. Most of the children received the DPT vaccine as well. This trial was not controlled, randomized, or blinded.³⁵

So, the inactivated polio vaccine (IPV) “safety turtle” – established in two small trials, only one of them an RCT with any sort of control group – stands on the back of Lederle’s oral polio vaccine (OPV) safety turtle. And what lies below that turtle’s feet? Only thin air, apparently. The Lederle vaccine, introduced in the US in the early 1960s, has no public documentation of any clinical trials performed pre-licensure, or thereafter.

Prevnar Vaccine: The Prevnar vaccine brand protects against multiple strains of the pneumococcus bacterium that can cause pneumonia. The Prevnar-13 vaccine protects against 13 bacterial strains and has been in routine use in the US since 2010.^[s] The vaccine replaced the older-generation vaccine called Prevnar, which was introduced in 2000 and protected against 7 bacterial strains.

How was Prevnar-13’s safety tested before approval? Browsing the vaccine’s package insert reveals that it was tested against its predecessor, Prevnar.³⁶ In these trials, severe adverse events were reported in 1 in 12 infants receiving Prevnar-13 (8.2% of subjects) and slightly less often in Prevnar subjects (7.2%).³⁷ But how many babies who participated in the trial would have experienced severe medical events if not vaccinated at all? That question cannot be answered because the Prevnar-13 trials did not include a placebo control group. Unsurprisingly, the rate of adverse events in the Prevnar-13 was generally similar to, albeit slightly higher than, the rate of its predecessor; thus, the vaccine was declared “safe” and approved for use by the FDA.

The Prevnar-13 turtle stands on the back of the Prevnar turtle. And what is the Prevnar turtle standing on? The answer: On the back of another turtle, which is standing on nothing but thin air, as we shall immediately see.

Prior to its approval, the Prevnar vaccine underwent a major clinical trial in the United States. In this trial approximately 17,000 infants received Prevnar and a similar number of controls received a vaccine against the meningococcus bacterium.³⁸ A review of the scientific paper reporting the results of the trial reveals that about 1,000 subjects in total were hospitalized (about 1 in every 35 infants), and about 1 in 16 had emergency room (ER) visits within 30 days of receiving the vaccine.³⁹ In addition to the Prevnar or meningococcal vaccine, all trial subjects received concurrent DTP or DTaP vaccines. (Note that administering the trial and control vaccines concurrently with other vaccines further obscures the results, as it impossible to determine which adverse events are due to which vaccine(s).)

And what about that meningococcal vaccine received by the control group subjects? In 1998, the year its trial took place, there was no existing alternative to the Prevnar vaccine. Thus, there were no ethical reasons not to give the control group an inert saline injection. Yet the manufacturer chose to give the control group the meningococcal vaccine instead, despite the fact that it had not yet been approved by the FDA and was still “experimental”.⁴⁰ Why would the manufacturer, as well as FDA and other licensing approval bodies, prefer using an experimental vaccine over the safe, economical, practical, and ethical alternative of a saline placebo? There can be only one answer: to hide the true rate of Prevnar’s adverse events.

Hepatitis B Vaccine: Engerix-B is a hepatitis B vaccine manufactured by GSK, which is routinely given to US infants.^[t] How was it tested for safety? The vaccine package insert provides an exceptionally brief description: “The incidence of local and systemic reactions was comparable to those of plasma derived hepatitis B vaccines.”⁴¹ The package insert mentions another safety study, carried out in children aged 11 to 15 years, where both trial and control groups received the Engerix-B vaccine, though different dosing regimens were applied.⁴²

Twinrix, also made by GSK, is a combined hepatitis A and B vaccine. This vaccine was tested in clinical trials against a control group receiving the company’s single hepatitis A and B vaccines (Havrix and Engerix-B, respectively).⁴³

Recombivax-HB is a hepatitis B vaccine produced by Merck. Surprisingly, its package insert does not mention any safety RCT in infants that was performed for this vaccine.⁴⁴

In summary, the safety of the three hepatitis B vaccines routinely given to newborns has not been tested in a single randomized controlled clinical trial in which a control group received a placebo. As should be all too familiar by now, it’s “turtles all the way down” again.

Hepatitis A Vaccine: Two hepatitis A vaccines are routinely used in the United States:^[u] the GSK Havrix vaccine and Merck’s Vaqta vaccine.

In a large-scale trial in Thailand with over 40,000 participants, GSK’s Havrix was compared with a control group which received Engerix-B, the company’s hepatitis B vaccine. In three other clinical studies, the trial groups received the Havrix vaccine concurrently with another vaccine and the control groups received several other vaccines (MMR, varicella, and more).⁴⁵

The safety testing of Merck’s vaccine, Vaqta, was not much different.

According to FDA licensing documents, the vaccine was tested in two clinical trials:⁴⁶ The first one (“Monroe”) had no control group, while the second, in addition to having no control group, administered Vaqta along with two other vaccines.^[v] Vaqta’s package insert mentions several additional studies but none with a control group that received a placebo. It is interesting to note that contrary to the FDA licensing document, the package insert states that there was a control group in the “Monroe” study and that it received a placebo. A closer look reveals that the “placebo” used contained the vaccine’s aluminum adjuvant,^{[w] 47} and further examination reveals that it also contained the preservative thimerosal (a mercury-based substance removed from most vaccines in the early 2000s).⁴⁸ As mercury is a potent neurotoxin and aluminum adjuvants are used because they stimulate a strong immune reaction, both of these substances are a far cry from being inert and safety-neutral.

Measles, Mumps, Rubella, and Varicella (Chickenpox) Vaccine: Merck manufactures a single-dose varicella vaccine called Varivax. The safety section of its package insert mentions a “double-blind, placebo-controlled study” of 914 healthy children and adolescents, in which only two mild symptoms, pain and redness at the injection site, “occurred at a significantly greater rate in vaccine recipients than in placebo recipients.”⁴⁹ Does that mean a real placebo was used in this trial? Definitely not. The paper describing the study reveals that the so-called placebo given to the control group was actually the test vaccine from which the viral component was removed.⁵⁰ No wonder the rates of adverse events were similar between the trial and control groups.⁵¹ Another controlled study compared the safety of two different formulations of the Varivax vaccine. According to the leaflet, the safety profiles of the two formulations were comparable.

The two measles-mumps-rubella vaccines licensed for use in the US^[x] are a 3-in-1 vaccine called MMR II, and a 4-in-1 vaccine (measles-mumps-rubella and varicella) called ProQuad. Both are manufactured by Merck.

ProQuad’s safety was tested in several randomized clinical trials, most of which were not blinded (“open label” studies). The largest RCT compared ProQuad to a control group that received the older-generation MMR II and the Varivax vaccine at the same time. Another study in children 4-6 years old divided the subjects into three groups: The first received ProQuad and “placebo”; the second, MMR II and “placebo”; and the third, MMR II and Varivax. In the open label studies, the participants of both trial and control groups received additional vaccines.⁵²

The package insert for MMR II does not mention any safety trials.⁵³ As with the polio vaccine (IPOL) described earlier, a FOIA request revealed that the vaccine was tested in the mid-1970s in eight small clinical trials.⁵⁴ The control groups in all of the trials received either the predecessor vaccine (MMR), a measles-rubella (MR) vaccine, or a single-dose of the rubella vaccine. A total of approximately 850 children received MMR II. Some of the trials seem to have been randomized, but none were blinded. These trials, considered either singly or in combination, do not meet the current requirement of a Phase 3 randomized controlled trial, which might explain their complete absence from the package insert.

Finally, let’s examine how the original MMR vaccine, licensed in 1971, was tested before getting the nod from the regulator. Will we find a placebo-receiving control group in this legacy vaccine’s trials? Well, almost. Similar to MMR II, the original MMR was tested in a few small-to-medium trials wherein the newer vaccine was given to a total of more than 1,000 infants and children. The control groups’ subjects totaled about one tenth that number, and most of them were siblings of the vaccinated children (which violates the randomization principle). The control group participants received no injection at all, which means the studies were not blinded; everyone knew who got the vaccine and who didn’t. As with MMR II, the MMR trials fail to meet the Phase 3 RCT bar.⁵⁵

Evidently, the safety of the MMR line of vaccines, like the rest of the vaccines in the US childhood vaccination program, was tested according to the de facto industry rule of “turtles all the way down”.

As we’ve clearly illustrated in the preceding sections, not one of the vaccines the CDC recommends all American children receive was tested for safety in a Phase 3 clinical trial where the control group received an inert placebo. All the vaccines reviewed in the preceding pages – of which tens of millions of doses are administered to infants and toddlers in the US every year – were tested in trials which did not include any control group at all, or ones in which the so-called control group received at least one other vaccine.

Is it just coincidence that none of these vaccines has been tested against a true placebo, despite the fact that in many cases doing so would have been easier, cheaper, and yielded more valid results than the testing that was done? Is it just an accident of fate that the accepted methodology of all childhood vaccine trials obscures the real rate of adverse events of the new vaccine? That seems highly improbable.

As explained at the start of this discussion, testing the safety of a next-generation vaccine against its predecessor is justifiable on ethical grounds: Withholding an existing and proven treatment from control group subjects would be immoral. However, there is no justification for conducting a chain of trials (turtle upon turtle upon turtle) that ultimately stands on nothing but air. Moreover, what possible rationale could justify trials for new vaccines wherein the control groups receive other (sometimes experimental) vaccines? Would a safety trial for a new cigarette have any credibility at all if the “control” group consisted of subjects who smoked a different kind of cigarette?

Whether or not you believe this trial methodology is ethical, its consequence remains the same: The true rate of adverse events of routine childhood vaccines is virtually unknown; therefore, there is no scientific basis for claiming they’re safe.

The fact that we don’t know how often childhood vaccines hurt the children who receive them casts a dark shadow over the legitimacy of vaccine programs the world over. But that is not all. Even worse, as we shall shortly see, safety trials conducted for some childhood vaccines blatantly and seriously violate the medical code of ethics. In any vaccine clinical trial, a balance must be struck between the vaccine’s potential benefits (disease protection) and potential risks (adverse events). When control subjects in vaccine trials receive another type of vaccine, even if it’s done in order to obfuscate the real rate of adverse events of the vaccine being tested, the compound they receive is at least of some potential benefit to them. However, in the rotavirus vaccine trials this imperative ethical risk-to-benefit balance was blatantly violated.

Designing clinical trials for the RotaTeq and Rotarix vaccines was particularly challenging for their manufacturers, Merck and GSK, respectively. To begin with, the first rotavirus vaccine brand (RotaShield) was recalled from the market⁵⁶ after it was found to significantly increase the risk of intussusception, a highly dangerous condition in infants.^[y] This meant that clinical trials for the new rotavirus vaccines had to adhere to higher safety standards. In addition, the companies faced an equally serious problem: With RotaShield off the market, there was no suitable vaccine to give to control group subjects.

A rotavirus vaccine dose, a few drops of an opaque liquid, is consumed orally.^[z] Hence, the control group in its clinical trials could not receive a vaccine administered via injection as it would violate the RCT blinding principle. If the trial group were vaccinated orally, while the control group was injected, it would be easy to tell the two groups apart. At the time the rotavirus vaccine trials began, there was no other orally ingested vaccine licensed for use. The use of the live polio vaccine (OPV), also consumed by mouth, was terminated in Western countries several years earlier.^[a2] As a result, there was no oral vaccine available to compare with rotavirus vaccines in clinical trials.

Another option would be to give the control group a few drops of a neutral liquid, such as a solution of sugar or salt water. These compounds are safe, inexpensive and convenient to use – ideal for the purpose of testing the vaccine’s efficacy and safety. Because these were entirely new vaccines, which had no alternative, there were no ethical objections to using such a solution.

So, on the one hand, rotavirus vaccine manufacturers did not have a ready-made vaccine available for use in the control group, and on the other, there was no impediment to using a cheap, available and effective substance, such as sugar water. How, then, did they choose to conduct their Phase 3 clinical trials? A preliminary examination of the clinical trial record of the rotavirus vaccine shows that the control groups in the RotaTeq and Rotarix trials received… a placebo!⁵⁷ Was this, then, the industry’s first breach of the sacred tradition that vaccines never be tested against a true placebo? Were the rotavirus vaccine trials the first to provide reliable and relevant information about the rate of adverse events of a childhood vaccine?

The answer to these questions is, unfortunately, “no and no”.

Examining one of the licensing documents submitted to the FDA by GSK⁵⁸ indicates that the placebo received by the control group in the main Rotarix trial (which included approximately 63,000 infants) is nothing but the tested vaccine without its antigenic component.^[b2] This compound, the vaccine-sans-antigen (sans means without), is well suited for testing the efficacy of the vaccine as it does not produce rotavirus antibodies. However, when it comes to safety, it’s a whole different ballgame: The vaccine-sans-antigen is a potentially potent compound whose side effects are likely to be quite similar to those of the vaccine being tested.

And what was the placebo in Merck’s RotaTeq vaccine trial? That’s difficult to say because Merck deleted its description from the licensing document submitted to the FDA.⁵⁹ It appears that the trial’s placebo is a trade secret, which implies its contents were very similar to the vaccine’s. Further examination of RotaTeq documents supports this hypothesis: In another RotaTeq clinical trial, the control group received the vaccine-sans-antigen, similar to the compound control group subjects received in the Rotarix trial.⁶⁰

The bioactivity of the compounds given to the control groups in rotavirus vaccine trials was seemingly apparent in the rate of adverse events reported in the trials. In the Rotarix trial, about 1 in 30 control group subjects experienced a “severe” medical event (a rate which was even slightly higher than that of the trial group), and a similar proportion of participants was hospitalized. In addition, 16 infants suffered intussusception and 43 died.⁶¹ In the RotaTeq trial, similar rates were recorded in the control group: Serious adverse events were reported in 1 of every 40 subjects, 15 suffered intussusception, and 20 infants died.⁶²

Using the word placebo to describe the vaccine-sans-antigen leaves the false impression that it is a safe compound that has no side effects of its own. Formal documents, which reference the rotavirus vaccine trials, rely on the supposed biological neutrality of that “placebo”. One example is the Rotarix vaccine package insert, which states in the clause discussing the rate of intussusception reported in pre-licensure trials: “No increased risk of intussusception was observed in this clinical trial following administration of ROTARIX when compared with placebo.”⁶³ (The trial in question is the same trial referenced above. There are plenty of other examples, too).⁶⁴ Nowhere is there any reference to the actual contents of that “placebo”.

The rotavirus vaccine makers were evidently able to find a creative solution to the challenge they faced. They gave their trials’ control groups compounds that were very similar to their vaccines, and – as was, no doubt, expected – the resultant rates of adverse events were not significantly different from those observed in the trial groups. In future trials of next-generation rotavirus vaccines, GSK and Merck will be able to give their control groups the standard “placebo” – the currently licensed vaccine – whose safety “was already proven” in its pre-licensure trials.

But there’s a fly in this sticky ointment.

As previously discussed, the ethical standards for using children as subjects in clinical trials are exceptionally high. Clinical trial designers must ensure that planned procedures are balanced with respect to the expected benefit and risk to the participating infant or child. If a child subject is likely to receive no benefit, the potential harm must be “minimal” or only “slightly above the minimum”, and by no means permanent or irreparable. In addition, the risks associated with any procedures must be well-known in advance.⁶⁵

In stark contrast to the standards above, tens of thousands of infants in the control groups of the rotavirus vaccine trials received compounds that could provide no potential benefit to the recipient yet carried significant risk. Neither GSK’s nor Merck’s vaccine-sans-antigen could possibly prevent rotavirus as they did not contain the antigenic particles that evoke immune reactions to the virus. On the other hand, these compounds had significant potential to cause harm, as demonstrated in the trials. (Remember, 1 in every 30 or 40 control group subjects experienced a serious adverse event). In addition, the safety profiles for the vaccines-sans-antigens were unknown (and, for all we know, still are) as they were new compounds specifically formulated for the rotavirus trials with no documentation of past safety studies. Hence, the health risks associated with administering them to infants was undetermined.

To sum up, tens of thousands of infants were given an utterly useless compound whose safety was unknown and whose side effects could be (and probably were in some cases) severe and permanent. Thus, the Phase 3 clinical trials of the rotavirus vaccine constitute blatant violations of the medical code of ethics.

This ruthless breach of ethics and morality is highlighted by the fact that there was no scientific justification for giving the vaccine-sans-antigen to the control group other than a malicious intention to conceal the experimental vaccine’s true rate of adverse events. Using a real placebo that posed no health risk – a few drops of sugar or salt water – would have cost less and led to more scientifically valid conclusions by enabling straightforward calculations of the true adverse event rates as well as vaccine efficacy.

The manner in which the rotavirus vaccine trials were conducted raises grave questions which should not be directed solely toward the vaccines’ manufacturers. The FDA supervises the vaccine approval process, and it is the FDA that approved these trials.^[c2] The vaccine also received CDC approval and that of other health authorities around the world, even though its pre-licensure trials unnecessarily endangered tens of thousands of children and may have caused serious harm to hundreds, as well as dozens of needless deaths.

The Declaration of Helsinki is the ethical code governing the conduct of human medical experimentation. The Declaration was formulated for the medical-scientific community by the World Medical Association and is considered the ethical cornerstone of the medical research field. It leaves no doubt as to the ethical violations perpetrated in the rotavirus trials:

Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits […] physicians must assess whether to continue, modify or immediately stop the study.

. . . [A] potential research subject who is incapable of giving informed consent [...] must not be included in a research study that has no likelihood of benefit for them unless […] the research entails only minimal risk and minimal burden.⁶⁶

The Nuremberg Code, the medical code of ethics established in the late 1940s to bring Nazi doctors to justice, constitutes the basis of the Declaration of Helsinki. It too underlines the immorality of the rotavirus vaccine trials: “[An] experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.”⁶⁷ A similar conclusion was also reached by a World Health Organization (WHO) committee that recently examined placebo use in clinical trials.⁶⁸

Ponder it as you will, you won’t find a satisfactory explanation for the way the rotavirus vaccine trials were conducted other than the malicious desire to assist the manufacturers in obscuring and concealing the vaccines’ true adverse event rates. This demonstrates that the public health establishment is willing to go to great lengths to maintain the pretense of vaccine safety, casting aside medical ethics and even fundamental principles of morality in the process.

Table 1 summarizes the safety testing performed in Phase 3 clinical trials for the vaccines included in the CDC-recommended childhood vaccination program.

Table 1a b c d Table 1: The control group in Phase 3 clinical trials of CDC's routine childhood vaccines

As summarized in the table above, the manufacturers’ package inserts and FDA licensing documents indicate that none of the US routine childhood vaccines has been tested against a true placebo. It is very unlikely that new documents which attest to the opposite will suddenly appear. It is also highly improbable that a new technique for calculating the true rate of vaccine adverse events in an RCT by comparing it to population background rates or to a non-placebo control group will miraculously emerge. A moral justification for giving control group infants a compound that could seriously harm them, while providing them with no potential benefit, will also not be forthcoming anytime soon.

However, because the arguments made in this chapter undermine the very foundations of the childhood vaccine program, devout believers in the “vaccines are safe and effective” mantra try hard to refute them. Their popular arguments and suggested responses are presented below.

Important Note: When addressing alleged refutations to the content of this chapter, the first response should be to politely request scientific references backing them up. When facing the inevitable and grave consequences of the material presented in this chapter, vaccine proponents sometimes resort to baseless, even borderline imaginary, claims. In many cases, asking for a valid scientific reference that backs up a claim will quickly put the argument to rest.

“A placebo in vaccine clinical trials is only used for the purpose of testing vaccine efficacy.” – This is a bizarre claim which has no scientific basis (just ask for a scientific reference – you won’t get one). A (real) placebo given to the control group in a vaccine clinical trial provides a “background rate” for both efficacy and safety. Therefore, in a trial which has a placebo group, both vaccine efficacy and the incidence of adverse events could be easily calculated by comparing results in trial vs. control groups.

“It is unethical not to give the control group another vaccine.” – The practice of always testing vaccines against other vaccines gives rise to the “turtles all the way down” scenario, where the true rate of adverse events of any childhood vaccine is never determined. In fact, the opposite is true: It is unethical not to conduct at least one trial from which one can reliably estimate the rate of adverse events before a vaccine is licensed and widely used.

As reviewed in this chapter, medical ethics guidelines permit the administration of a placebo to a control group in a clinical trial of a completely new vaccine and to a control group in a three-arm trial of a next-generation vaccine.

“When testing a next-generation vaccine, it is unethical not to give the control group the current vaccine.” – This argument is similar to the previous one, but focuses specifically on the next-generation vaccines. It certainly makes sense to test the safety of a next-generation vaccine against the current one, but if the current vaccine has never been previously tested against a placebo, it is “turtles all the way down” again; that is, the data collected from the vaccine’s clinical trials is inadequate for establishing a true safety profile.

The solution to the above is straightforward: Conduct a three-arm trial with next-generation vaccine, current vaccine, and placebo groups. This allows the comparison of the safety of the new vaccine to the existing one, as well as obtaining an estimation of the absolute rate of the new vaccine’s adverse events (by comparing it to placebo). A trial of this kind has never been conducted for any of the routine childhood vaccines.

“It is sufficient to test a new vaccine against another vaccine whose rate of adverse events was determined in a previous trial (or measured for a country/region/city population).” – As explained in the chapter, the results of one randomized controlled trial (RCT) cannot be compared to that of another RCT, nor to population “background rates” (even if those are known, which is uncommon) because it violates randomization. Known or unknown differences may exist between the studies’ populations that could potentially skew the results significantly. Vaccine package inserts, which are published by the manufacturers and approved by health authorities, state this explicitly.

“It is sufficient to test a next-generation vaccine against the current vaccine, as the current vaccine has already been given to millions over many years and proven safe.” –The argument implies that if we know that a certain current vaccine is safe and a control group in a next-generation vaccine trial is given that vaccine, then if adverse events are comparable between the groups, it can be concluded that the new vaccine is also safe for use.

First, this presupposes that the current vaccine is safe. But we cannot make that assumption if the current vaccine itself was tested in clinical trials designed to obfuscate its true rate of adverse events. That is, the industry’s “gold standard”, the RCT, was “cooked” (as was the case in this chapter’s examples) in order to hide the health risks of the tested vaccine. Instead, we must base our judgment of its safety on inferior studies^[d2] performed only after the vaccine has been on the market for several years.

Secondly, without a placebo control group there is no way to prove that the vaccine being tested is actually safe. For example, in one of the DTaP vaccine trials, 1 in every 22 subjects in the trial group was admitted to the hospital. A similar hospitalization rate was also reported in the control group (which received the older-generation DTP vaccine).⁶⁹ Is this a normal background rate? Would nearly 5% of all infants really end up in the hospital if they didn’t receive these vaccines? Should we regard both these vaccines, which appear to cause an alarmingly high rate of hospitalizations, as “safe” simply because they have similar hospitalization rates? Or is the reality that neither of them are safe? Definitive answers to these questions could only be obtained by adding a placebo group to the trial. Only then could we calculate a meaningful baseline hospitalization rate that could be put to good use in evaluating the vaccine’s safety.

In any case, the above claim is irrelevant for trials of entirely new vaccines for which there are no valid reasons not to use a real placebo control.

“The safety of the [xyz] vaccine was extensively studied after it was approved for wide use and was found to be excellent.” – Statistical (epidemiological) studies, which are typically conducted only after a vaccine has been in wide use, are considered inferior to RCT studies. The RCT is the industry’s “gold standard”, and every new vaccine must undergo such a trial before it is approved for use. It would not be acceptable or reasonable to approve a vaccine for use without adequate clinical studies, and then, after it was administered to millions of babies, retroactively endorse it based on methodologically inferior studies.

“The assertion that vaccines are never tested against a placebo is false. Here are some references to vaccine clinical trials in which the control group received a real placebo.”⁷⁰ – The claim made in this chapter is not that vaccines in general are never tested against placebo in their pre-licensure process. Rather, it is childhood vaccines recommended by the CDC that were never tested against a placebo. The references provided to support the above statement do not refute this claim, as they link to trials of adult vaccines, or vaccines that are not used in the United States. In fact, these references reinforce this chapter’s arguments, as they demonstrate that using a placebo control group in a vaccine RCT is valid, feasible, methodologically sound, and ethical.

“Contrary to your claim, a placebo is not mandatory in a vaccine clinical trial. Instead, the control group could be given nothing (i.e., no intervention).” – In a double-blinded randomized controlled trial (RCT), the control group must receive a compound that looks the same and is administered in the same way as the tested compound. This eliminates potential reporting bias. For example, subjects who know they received the experimental vaccine are more likely to report adverse events than control group participants who received no intervention. This rule also applies to trials with infant subjects even though it is generally believed they are not affected by this bias, because their parents, who are usually present at the time of vaccination, can certainly be affected.

In any case, there are no current childhood vaccines that were tested in clinical trials that included a no-intervention control group, which renders the above claim irrelevant.

“The vaccine-sans-antigen that was given to the control group in the rotavirus trials is a safe compound since it is made of a mixture of ingredients, each of which is generally considered to be safe.” – This is yet another baseless claim that has no scientific or factual basis. Even if we presuppose that the individual ingredients in the compound given to the control group in the rotavirus trials were harmless, we cannot assume their specific mixture was harmless, too. This is a fundamental tenet of drug and vaccine testing methodology: A compound’s safety is not the sum of the safety of its parts. Thus, we cannot presume its safety based on a theoretical calculation of the aggregated safety of its ingredients. It must be clinically tested before it is approved for wide use (even more so, if given to babies).

Additionally, in the case of the rotavirus vaccine trials, neither the manufacturers nor the licensing bodies claimed that the vaccine-sans-antigen that was given to the control group was considered, or proven to be, safe or that its safety profile was known. If anyone claims the opposite, they must provide the scientific references to back it up.

Giving the control group the vaccine-sans-antigen is the proper way to test the vaccine’s antigen efficacy and safety.” – Once again, this is a baseless claim that has no scientific merit. A clinical trial in which the trial group receives the test vaccine and the control group the vaccine-sans-antigen compares two experimental compounds whose safety profiles are unknown. Therefore, such a trial design precludes calculation of the true rate of adverse events of the test vaccine. For a valid determination, the control group should receive a placebo, which is a compound whose rate of adverse events is known and is very close to zero. In clinical trials using vaccine-sans-antigen compounds in the control group (for example, the rotavirus vaccine trials), researchers reasoned that “no significant difference in the rate of adverse events was observed in trial and placebo groups.” However, this claim is critically flawed, since the “placebo” given to the control group was not neutral (i.e., one which had zero side effects), but rather a bioactive compound whose rate of side effects was unknown.

In addition, the safety of the vaccine antigen is irrelevant as it is not administered by itself, but rather in combination with all the vaccine’s other ingredients. It’s the safety of the vaccine as a whole that matters, and that is not best tested by comparing it to the vaccine-sans-antigen.

In any event, the above discussion should only be considered theoretical, since administering a potentially harmful substance with no potential benefit to infants in a clinical trial violates the medical code of ethics as well as fundamental moral principles.

“It is inconceivable that every doctor and researcher in the entire world would approve, or retroactively approve, of a flawed methodology for testing vaccines’ safety before they are licensed. Are all of them taking part in a huge conspiracy?” – Providing a complete and comprehensive answer to this claim goes beyond the scope of this chapter. In short, the vast majority of physicians and researchers are completely unaware of the manner in which vaccine safety trials are designed and conducted and the methodological flaws inherent in that process.

Regardless, this claim is essentially irrelevant, as it does not directly answer the arguments presented in the chapter and therefore cannot refute them. A doctor or researcher who has studied vaccine safety and maintains there are no flaws in their licensing process should respond directly to the arguments made in this chapter instead of asking the public to blindly agree based on professional authority alone.

Vaccines, as opposed to drugs, are given to healthy babies and thus must meet a particularly high safety standard. Clinical trials of new vaccines must be impeccably designed and performed, thereby providing high-quality, reliable data about the products’ efficacy, and more importantly, about their safety. Anything less is socially and morally unacceptable.

Vaccine manufacturers and health authorities worldwide frequently assure us, the public, that vaccines are tested at the highest possible level and that the rigorous series of clinical trials they undergo as part of the licensing process ensures that vaccines are truly safe and effective.

These assurances, however, are meaningless at best and deliberately misleading at worst.

As we have seen in this chapter, vaccine trials are designed and performed in such a way as to ensure that the true extent of adverse events is hidden from the public. There is not a single vaccine in the US routine childhood vaccination program whose true rate of adverse events is known. The assertion that vaccines cause serious side effects in “one in a million” vaccinees contradicts the results of numerous clinical trials in which serious adverse events were reported in 1 in 40, 30, or even as few as 20 vaccinated infants. After becoming acquainted with the finer details of vaccine safety trials, hearing the familiar tune of “a similar rate of adverse events was reported in the control group” (which received another vaccine or similar compound) comes off as ludicrous, cynical, and patently immoral.

Current vaccine clinical trial methodology completely invalidates the claims that vaccines are safe and that they are thoroughly and rigorously tested. And pulling out that bogus card completely topples the childhood vaccine program’s house of cards, as officials’ assurances of vaccine safety rely primarily on deliberately flawed, industry-sponsored clinical trials.

Furthermore, some of the clinical trials that have been conducted for routine childhood vaccines, which were approved by relevant health authorities, blatantly violated the medical code of ethics (the Declaration of Helsinki) and fundamental principles of morality. In these trials, infants in the control groups were given completely useless compounds (an antigen-free vaccine) whose safety was unknown and which had the potential to cause serious and irreversible damage to health, including death.

Any reader looking for a quick and definitive understanding of the truth about vaccine safety – well, you can put this book down right now. You have your answer: The entire vaccine program is based on a deliberate cover-up of true vaccine adverse event rates. This seemingly mighty fortress, carefully constructed over many decades and fortified by countless officials, researchers, and physicians – actually stands on nothing but turtles all the way down.

Ask your doctor:

• Was the vaccine that you are recommending tested in a pre-licensure clinical trial with a (real) placebo control group? If not, how do you (or anyone else, for that matter) calculate its true rate of adverse events?
• Is it morally acceptable to conduct a clinical trial in infants for a new vaccine, where the “control group” receives an untested compound, i.e., the vaccine-sans-antigen, which is likely to cause irreversible side effects and has no potential benefit?

“There are three kinds of lies: lies, damned lies, and statistics.”

In the previous chapter we introduced the medical field of epidemiology, its capabilities and limitations. In this chapter we will look at how medical and scientific bodies make use of biased epidemiological research to present an illusion of vaccine safety to the public. We will document this claim through in-depth analysis of a number of well-known vaccine safety studies from the past fifteen years, highlighting their fundamental flaws and describing the circumstances surrounding their publication.

The previous chapters exposed some of the systematic ways medical authorities and vaccine manufacturers cover up the true extent of vaccine adverse events. Given what we already know, it would be reasonable to suspect that the medical establishment would not, when necessary, shy away from initiating and promoting further biased research to achieve this objective. But in order to convince the vigilant reader that that is indeed what is happening, we must first answer some inevitable questions: Why would the medical establishment encourage biased vaccine safety research? How can the establishment control the outcome of vaccine safety research? Why would researchers and academics cooperate in producing biased science? Why would medical journals publish faulty or biased studies? And how could scientific studies be systematically biased without the public catching on?

Answering these questions is essential if one wants to understand exactly how the medical establishment uses epidemiological studies to preserve vaccines’ reputation. Therefore, before delving into the specifics of certain vaccine safety studies, we will devote the next few pages to outlining the context in which these studies are performed and published. Once one learns how science funding works and how vaccine safety research is conducted and published, it will not be possible to dismiss specific researchers’ breaches of the scientific code of ethics as the actions of a few “bad apples”. By putting our examples of faulty studies in context, taking into account the relevant players and the motives that drive them, a coherent picture emerges of a deliberate and systemic process used to generate a complex of misleading scientific research designed to cover up the truth about vaccine safety.

Toward the end of the 1990s, after a relatively quiet decade and a half, concerns about vaccine safety began to re-emerge in the United States. This period of relative tranquility was preceded by the turbulence of the ‘70s and early ‘80s, when the media focused on the purported harms of the DTP, or “triple-vaccine” (a vaccine against diphtheria, tetanus and pertussis). National headlines followed the 1982 airing of the TV documentary DPT: Vaccine Roulette, which included footage of children who suffered severe adverse reactions following DTP vaccination.¹ Across the Atlantic, similar stories about the DTP vaccine were published in the UK as early as the mid-1970s. These stories, backed by credible testimony from renowned doctors, sparked a public outcry that led the British government to suspend DTP vaccination for several years.² Despite media chatter, however, and the support of a handful of maverick doctors and researchers, re-examination of DTP safety was limited in scope and depth. Public debate at the time was almost entirely confined to mainstream media – television, newspapers, and medical journals. Any information that reached the public was pre-filtered and edited, as was the norm in those days, making it difficult for parents of vaccine-injured children to make their case publicly, find like-minded parents, and win allies to their cause.

Once the DTP storm subsided, medical authorities enjoyed a quiet period that ended abruptly in the late 1990s. Public interest this time around was focused on the MMR – another triple vaccine (for measles, mumps and rubella) – and the mercury-based preservative thimerosal used in many of the routine childhood vaccines. Concerns about the MMR arose in the UK in 1998 with the publication of a paper by Dr. Andrew Wakefield and colleagues in The Lancet medical journal. Wakefield and his 12 co-authors suggested that the MMR vaccine might have caused autism and inflammatory bowel disease in some children who regressed developmentally following MMR vaccination.³ At nearly the same time in the United States, the FDA calculated, for the first time, the amount of mercury infants were receiving in routine vaccinations and discovered that the cumulative amount far exceeded the threshold considered safe by various government health agencies. Following these findings, even before the information reached the public, a number of US health organizations recommended removing thimerosal from childhood vaccines.⁴

The establishment’s sudden interest in removing mercury from vaccines caught the attention of some parents of autistic children. These parents were already collaborating in efforts to identify the causes behind the huge rise in autism rates and to find effective treatments for their children.⁵ The parents’ activities led to lively public discourse regarding an apparent link between vaccines and autism that culminated in a series of Congressional hearings from 2000–2002.⁶

The renewed public interest in vaccine safety issues (and particularly in the vaccine–autism link) accelerated during the next decade after the breakout of the internet in the early 2000s. The trickle turned into a creek, then into a mighty river, creating a new and unprecedented challenge to those in charge of the vaccine program. Newly created websites, mailing lists, and online forums enabled parents to discuss their children’s adverse vaccine reactions in ever-increasing numbers. The internet also enabled parents to gather vaccine-related information more easily and share it with other parents. Everything related to vaccines and vaccine policy, from the real risks of vaccine-preventable diseases to the dubious tactics of pharmaceutical companies, became the focus of intense online discussion. This information, which had, for the most part, been accumulating dust in the basements of public libraries, virtually inaccessible to the average parent, became available to anyone with an internet-connected computer. In addition, the Web became an amplifier for physicians and researchers who dared to criticize institutional vaccine policy.⁷ Thanks to the internet, these “rebel” professionals could now reach parents directly, bypassing the “old” media that had, until then, served as a de facto buffer between them and the general public.

Within a few short years, through vigorous collaborative efforts coordinated through the internet, parents and researchers accumulated a large body of knowledge critical of vaccines and vaccination, based in large part on rational, science-based, and compelling claims. The once tiny group of non-vaccinating parents expanded rapidly, growing louder and ever more critical, until they became a force to be reckoned with.⁸ Health authorities like the CDC could no longer ignore the parents. They had to go on the offensive, and they did so by putting science – and more precisely, epidemiology – at the forefront of the battle.

Health authorities’ response to the growing public criticism of vaccines was largely framed as “the (rational) scientists vs. the (emotional) parents”. According to this narrative, on one side of the debate stood science, represented by dignified experts who cited published research and echoed official health guidelines, while on the other stood parents (mostly mothers), who lacked formal relevant training and based their views on personal anecdotes and quack doctors’ publications.⁹ To enhance this narrative, authorities began commissioning studies on numerous vaccine-related topics to “beef up” the surprisingly small body of vaccine safety research and ostensibly provide decisive scientific answers to each and every criticism raised by parent advocacy groups.¹⁰

The authorities had several courses of action to choose from for their surge of vaccine safety research efforts. One obvious theoretical option would be to devise and conduct specialized medical tests and examinations on the infants and children allegedly harmed by vaccines in an attempt to better understand the biological factors and mechanisms underlying their medical conditions. If common features between the injured children emerged, they could further investigate them to identify exactly what was causing the damage – a vaccine, a particular vaccine ingredient, a combination of a vaccine and specific medical conditions, or even something unrelated to the vaccine itself.

As we saw in chapter 2, however, this line of investigation has never appealed to the medical establishment. Even today, after more than 60 years of scientific research in the modern era, there are very few mainstream physiological studies investigating vaccine adverse events. The establishment’s evident dislike for this line of inquiry is hardly surprising. Such studies could potentially draw scientific and public attention to injured children and to the alleged link between their injuries and the vaccines they received. Another tricky aspect of this approach, from health authorities’ perspective, is the relative difficulty of ensuring results favorable to vaccines. Physiological studies are largely based on standard biomedical tests, which are performed using instruments that produce precise numerical results. Attempting to “fix” such test results can be risky for researchers, since it is usually quite simple to send samples for retesting to another, independent, laboratory.

A “safer” research approach, then, would be to fund research that would look for, and find, non-vaccine factors responsible for the adverse reactions blamed on vaccines. US health authorities, for example, allocated more than a billion dollars over the past decade or so to study the (non-vaccine) causes of autism, most notably genetics.¹¹ But despite the vast resources invested in the search for “the autism gene”, the results have been quite disappointing. Genes alone, as it turns out, can explain only a tiny fraction, if any, of the huge rise in the autism rate.¹²

While physiological (genetic) research has failed repeatedly to deliver a convincing blow to the growing public criticism of vaccine safety, epidemiology – and, more specifically, retrospective observational studies – have turned out to be health authorities’ most effective tool in the public relations battle. Within a few years, dozens of vaccine-related epidemiological studies were conducted, funded by interested public and private entities. These studies approached vaccine safety from various angles and seemingly affirmed and reaffirmed vaccination’s clean bill of safety. Many studies addressed the suspected link between vaccines and autism. Others focused on refuting the alleged link between vaccines and chronic illnesses such as diabetes, asthma, and allergies. For every critical claim made by parent advocates, one or more epidemiological study soon appeared, presenting evidence that seems to clear vaccines of all charges. Thus, vaccine proponents could use these studies to emphatically deny the link to vaccination of virtually any alleged vaccine injury. With epidemiological science ostensibly backing their position, officials could credibly claim that “science did not find a link between vaccines and disease or condition X.”¹³ The torrent of epidemiological studies that began in the late 1990s continues to flow to the present day, ever increasing, as the public controversy over vaccines intensifies.

As described in the previous chapter, epidemiology deals with the study of population-level disease and is therefore ideal for making sweeping assertions about vaccine safety (although those assertions obviously depend on the quality of the studies). You may recall from chapter 4 that epidemiological studies can be distinguished by the intervention factor (interventional or observational), and the time-perspective factor (prospective or retrospective). Generally, interventional studies are more reliable than observational studies, and prospective studies yield higher quality results than retrospective studies.

Retrospective observational studies are relatively inexpensive and easier to perform. In addition, they have one more distinct feature that is crucial to the discussion that follows: Their results can be rather easily “adjusted”. This point becomes clear when comparing retrospective observational studies to randomized controlled trials (RCTs), the industry’s “gold standard”¹⁴ and the staple of the vaccine licensing process.

Random allocation of subjects into trial and control groups, as well as concealment of the participants’ grouping throughout the trial (blinding), considerably limits researchers’ ability to skew, intentionally or otherwise, the results of an RCT. Unfortunately, these advantages do not apply to retrospective observational studies.

Unlike in RCTs, where subjects are allocated to groups by “coin flip”, in retrospective observational studies researchers allocate the subjects according to their own criteria. Researchers can easily tweak selection criteria as they see fit, adding subjects to one group, removing them from another, or moving subjects from one group to another. Even when researchers formally declare that they have randomly allocated subjects – for example, in selecting members of the control group in a “case-control” study – we have only their word for it. Unlike clinical trials, non-interventional epidemiological studies are not inspected by government officials or any other formal body. Consequently, in most, possibly all, vaccine-related retrospective observational studies, there is no one who monitors researchers’ conduct and ensures that they adhere to the formal research plan and ethical standards.

A retrospective observational study is inferior to the RCT in another crucial aspect: blinding. In a retrospective study, where relevant events have already occurred and the data to be analyzed already exists, researchers can “massage” the results to achieve a predefined outcome. One technique already mentioned above is moving subjects between groups to change the resulting comparison between the groups. RCTs, on the other hand, are prospective, which means the data doesn’t exist at the time of subject allocation. Hence, it is much more difficult, and frequently impossible, for researchers to affect the outcome by fiddling with the group allocation process. To do so, they would need to accurately predict in advance how certain participants would react to the trial interventions, which isn’t usually feasible.

Though many retrospective observational studies are “controlled”, meaning they include a control group similar to an RCT, this, by itself, does not necessarily ensure credible results. Unlike in an RCT, researchers select who goes in the control group, which means they control the study’s “baseline”. Thus, with subjects’ data available to them, researchers can assign participants to study groups, run the statistical analysis, examine the outcomes, and reassign the participants if they don’t like the results. Since data analysis is fully computerized, they can easily repeat this process until desirable results are obtained.

The guidelines for retrospective observational studies, unlike RCTs, are quite flexible. As demonstrated in chapter 1, in order to come up with favorable safety results in pre-licensure clinical trials, manufacturers have to apply a rather ingenious workaround: testing a vaccine against a control group that receives a different vaccine (or a similar compound). The strict requirements of the trials – a control group, randomization, and blinding – gave rise to this devious method for clearing the required safety bar. Retrospective observational studies, however, are exempt from these restrictions, which means that researchers who wish to control a study’s outcome have a much easier task.

But why would scientists ever wish to purposely bias research results? Isn’t the discovery of scientific truth, and that alone, the purpose of their endeavors? Aren’t they bound by the lofty ideals of the scientific code of ethics, which demands that scientists perform their work with honesty, objectivity, and integrity?

Even in our day and age, when information flows more freely than ever before, many people still cling to a naïve view of science and the way it is practiced. Science is still regarded by many as trustworthy and objective, largely free of the internal politics, power struggles, vested interests, fraud, and corruption that plague other arenas. According to this view, which we call “The Pure Science Myth”, scientists are faithful professionals, diligently toiling in the lab, exercising cold logic, objectivity, and a well-developed sense of skepticism, all for the sake of providing a better future for humanity. Unlike most other professionals, scientists are expected to put objective truth before personal gain and self-interest, and if they ever fail to do so, they are to be harshly condemned by their peers.

The Pure Science Myth is deeply embedded in our culture. Elementary school children are told stories of the early days of science and its champions – Marie and Pierre Curie, Louis Pasteur, Alexander Fleming, and many others¹⁵ – not to forget Edward Jenner, inventor of the first vaccine.^[l3] These heroes, we were taught, have laid the foundation for modern science, to which we owe our present-day prosperity. These seeds sown in early childhood are continuously nurtured by the formal bodies that govern and manage science. Thus, official publications of scientific institutions paint an idyllic picture of the scientific process, omitting any mention of internal politics, pursuit of self-interest, ego battles, financial motives, and the like, as if science were magically devoid of these harmful, yet ubiquitous, human realities.¹⁶ The occasional corrupt scientist is depicted as an outlier, a “bad apple” who must be disciplined for science to maintain its hard-earned and well-deserved reputation.¹⁷

The discourse inside scientific circles, however, is rather different. Scientists themselves are well aware of the considerable gap, or even chasm, between the ideal and the way science actually works (described below).¹⁸ Outwardly, however, to the general public, they maintain the rosy fiction. It can hardly be denied that, like any other institutional discipline, science is money-driven and significantly affected by greed, self-interest, and other human flaws.^[m3] Thus, it is not at all surprising that research institutions and individual scientists occasionally deviate from the scientific ideals of objectivity, collaboration, and the uncompromising search for truth. But outliers exist in every field of human activity, and as long as any institution’s or individual scientist’s dishonest behavior can be attributed to personal ambition or an absence of moral fiber, it should not tarnish the reputation of science as a whole. Unfortunately, the ethical challenge presently facing science isn’t merely preventing and punishing scientific misconduct on the part of the occasional rogue scientist. The real problem in science goes much deeper and has broader implications. In fact, it is fundamental to the way in which modern science is conducted.

Scientific research costs huge amounts of money that mostly come from government and corporations. Without funding, there can be no science. The National Institutes of Health (NIH) alone is responsible for the allocation of a yearly biomedical research budget of $32 billion.¹⁹ This budget is spent on building labs, purchasing research equipment, and paying scientists’ salaries. But medical research budgets, however large, are not unlimited. As such, the institutional (or business) entities in charge of allocating research budgets set their own criteria and priorities, which, of course, align with their agendas and interests.²⁰ Thus, as one might expect, research money is directed toward studies that are consistent with, or at least do not oppose or contradict, the policies of the funding body.

Again, there can be no scientific research without funding. Researchers cannot operate without grants that allow them to purchase appropriate equipment, hire research assistants, perform trials and tests, and so on. Any researcher, even one holding a permanent (“tenured”) position in an academic institution, must keep raising money to continue working.²¹ Professional reputation and institutional status are largely contingent on the ability to secure funding,²² which makes researchers fully dependent on the research funding institutions. A scientist, however talented, cannot attain sustained scientific success without mastering the art of winning research grants. The powers that be must view the scientist’s work favorably; thus research proposals must be consistent with the funding institution’s policies. A research proposal that could threaten the sponsor’s interests is very likely to be turned down.²³ A scientist whose current research challenges the interests or policies of the research funder is likely to find that the money source dries up. Thus, scientists soon learn it is in their own best interests to align their research proposals with their sponsors’ expectations.^[n3] Failure to do so would result in the grant being awarded to a colleague who better anticipated the sponsor’s intentions and adjusted the research proposal, and its expected results, accordingly.²⁴

Since they possess the power to decide how research budgets are allocated, funding institutions effectively control the path that science takes, each in its respective area of responsibility. Often, they do not even have to express their views and intentions explicitly. Scientists will do their utmost to identify which way the wind is blowing and adjust their research proposals accordingly.

One could argue, perhaps, that institutions funding medical research have no clear preferences or vested interests in many, or even most, research areas, in which case they would allocate their research budgets according to strictly professional and objective considerations. For all we know this might be true, but if there is one enterprise in which the medical establishment has a clear, decisive, and unequivocal agenda – it is to promote vaccination.

25

25 Document Name: Financing Vaccines in the 21st Century: Assuring Access and Availability
https://www.nap.edu/catalog/10782/financing-vaccines-in-the-21st-century-assuring-access-and-availability
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Archive:
https://drive.google.com/open?id=15_AilgxcXkfeOJaNbCgScTr2MbeuMTuD
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Author/Year: IOM, 2004
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P 196:
The major contributors to vaccine research in the United States are companies conducting industrial research, government agencies (the National Institutes of Health [NIH] and the Department of Defense [DoD]), and the academic institutions they fund.
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Article Name: United States vaccine research: a delicate fabric of public and private collaboration. National Vaccine Advisory Committee.
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PMID: 9411380
Lead Author/Year: NVAC 1997
Journal: Pediatrics
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Table 2 on P 2:

Vaccine research is funded almost entirely by government bodies and the pharmaceutical industry, both of which have very clear vested interests in the success of the vaccine program.^{[o3] 25}

A vaccine manufacturer, like any commercial company, is primarily focused on making profit. Accordingly, it aims to sell as much of its product as it can, and for the highest possible price. News stories or scientific papers depicting vaccine products in a negative light could seriously hurt a company’s image and sales. Additionally, a defective or harmful vaccine could mean heavy fines imposed by the government.²⁶ So it is hardly surprising that a vaccine manufacturer, as a business entity, has no interest in funding or publishing scientific research unfavorable to its products. Hence, the studies they fund will almost always present vaccines in a positive light. Studies with negative results are likely to never see the light of day.²⁷ Researchers employed by pharmaceutical companies, whether company employees or academics hired to perform a specific study, understand the rules of the game well and follow them obediently. A Washington Post article aptly describes the established norms of the field: “When the company is footing the bill, the opportunities for bias are manifold: Company executives seeking to promote their drugs can design research that makes their products look better. They can select like-minded academics to perform the work. And they can run the statistics in ways that make their own drugs look better than they are. If troubling signs about a drug arise, they can steer clear of further exploration.”²⁸

Health authorities, for their part, have their own vested interest in the vaccine program. They regard vaccines as one of the greatest achievements of public health, and medicine in general.²⁹ Unlike pharmaceutical drugs, medical devices and most medical treatments – all of which are marketed mainly by their manufacturers – the childhood vaccine program is promoted directly, and almost exclusively, by health authorities. In the US national vaccine recommendations and policies are issued by the CDC, and state legislatures carry them out. As they direct and promote the vaccine program, these authorities would be the first to be blamed for any harm caused by a childhood vaccine. It is small wonder, then, that health authorities are not eager to fund studies that could link approved and marketed vaccines to adverse events. Why would they? Criticism would undoubtedly be directed at them, as it should be. This self-preservationist tendency to avoid funding research critical of vaccination strengthened from the late 1990s onwards, as public debate on vaccine safety heated up once again.

Their strategy to shore up trust in the vaccine program, then, is to convince the public that “the science on vaccines is settled” and that laypeople should accept the “scientific consensus” of “vaccine experts”. A spokesperson for the health establishment will patiently explain that the vaccine topic is extremely complex, and the average parent simply cannot make sense of it at all. Medical decisions should be based on expert advice, which in turn is firmly based in science.³⁰

The truth of the matter, however, is that vaccine science isn’t even remotely objective. The medical establishment conceals from a credulous public the grim reality that vaccine science is largely funded by interested parties which produce studies that advance the funder’s agenda, not the public’s.

This strategy capitalizes on the pervasiveness of The Pure Science Myth that the medical and scientific establishments have cultivated for many decades. This false narrative has been used for years to shore up the vaccine program’s reputation and to advance vaccine manufacturers’ profit margins. Thus, it serves those invested in the vaccine program well, as well as the scientific and medical professions in general, which enjoy generous funding and high public esteem. Most people are unaware that the institutions funding vaccine science are not objective, their motives are not pure, and the science they fund is neither impartial nor objective.

Before we look at a representative sample of vaccine safety studies, let’s do a short recap of the main points presented so far in this chapter.

The present surge of vaccine skepticism, which has been increasing since the late 1990s, requires the medical establishment to work harder to maintain the vaccine program’s reputation. In response to claims from parents and advocacy groups, health authorities have commissioned dozens of studies, most of them epidemiological, intended to provide scientific evidence of vaccine safety. Health authorities, along with pharmaceutical companies, control most of the vaccine safety research budget. Thus, authorities and vaccine makers fund research projects which are likely to support their agenda. Most of their studies have been retrospective and observational, the easiest type of epidemiological study to manipulate. Since securing research funds is so fundamental to a scientist’s career, there is never a shortage of researchers willing to adjust their results to align with the funding institution’s agenda. Thus, even while exploiting science’s longstanding reputation for integrity, authorities promote deceptive, manipulated research to a credulous public as decisive proof of vaccine safety.

For the most part, these contrived studies are tailored to address prevailing critical claims, such as “vaccines cause autism”, or “the HPV vaccine may lead to autoimmune disease”. The publication of these studies is typically accompanied by an orchestrated public relations campaign in the mainstream media to saturate the airwaves with the idea that “vaccines are [still] safe” and the criticism directed at them was found, once again, to be scientifically baseless. The orchestrators of this media campaign rightly assume that most parents will be either unable to access the original paper or will not bother to read it. The few who do read the paper will be unlikely to comprehend its scientific jargon or able to expose its flaws and biases.

Manipulated or falsified scientific research is, unfortunately, not uncommon. A review of studies that examined the issue found that almost 15% of scientists reported that their colleagues had falsified research results at least once. More than 70% reported that their peers had performed other dubious research activities. The review author also noted that, given the sensitivity of the issue, it is quite likely that the real numbers are higher than those reported.³¹ Obviously, this data indicates this is not the aberrant behavior of a few “bad apples” and implies a systemic problem that is a direct result of the manner in which scientific research is funded and conducted.

There are two main techniques used to manipulate epidemiological research: manipulation of the raw data and/or manipulation of the statistical analysis of the raw data.

Epidemiologists can tailor their research data set to support their desired outcome in numerous ways. They can select a small group of subjects in advance whose data will yield the desired outcome; select a large group and exclude those subjects that do not fit the desired outcome; use partial or unverified data that fits the desired outcome; specifically select a group of subjects and claim they were randomly selected; fiddle with selection criteria to change group composition, and more.

The statistical analysis phase also allows a great deal of flexibility. Researchers can process and reprocess the set of data using a variety of statistical techniques, choosing the one that produces the desired outcome. In addition, they can deliberately make erroneous or inappropriate calculations and then omit them from the published paper. They can also opt to include only calculations which show favorable results and exclude others that yield less desirable results.

Now let’s look at five vaccine safety studies. We will analyze, among other things, the authors’ conflicts of interest, study flaws, data manipulation techniques used, and how these studies were used to influence public opinion on vaccine safety. This small, yet representative, sample will demonstrate the deceptive way in which parties with vested interests use science to bolster vaccines’ public image.

Madsen 2002: MMR Vaccine and Autism
Paper name: “A Population-Based Study of Measles, Mumps, and Rubella Vaccination and Autism”³²
Journal and publication year: New England Journal of Medicine, 2002
Lead author: Kreesten Meldgaard Madsen
Type of study: Cohort retrospective observational study

Short description: a cohort study that examined the records of over half a million Danish children born between 1991 and 1998. The study compared the rate of autism between children vaccinated with the measles, mumps, and rubella vaccine (MMR) and those that were not vaccinated with the vaccine. The researchers found that the autism rate in both groups was almost identical, slightly lower, in fact, in the MMR group. The size of the study population and the fact that it included all Danish children born in the specified period led the authors to declare that “this study provides strong evidence against the hypothesis that MMR vaccination causes autism.”³³

Media and establishment response: The 2002 study by Madsen and colleagues is one of the most cited studies in the field of vaccine safety. The paper was published in a prestigious medical journal (NEJM) and received ample media attention.³⁴ It is referenced by many institutional webpages concerning the “debunked” link between vaccines and autism, including the websites of the CDC, the WHO, and the American Academy of Pediatrics (AAP).³⁵ The 2011 IOM report, discussed in chapter 2, names Madsen 2002 as one of only five vaccine–autism studies that met the quality threshold set by the committee.³⁶ Each of the aforementioned organizations maintain, echoing the authors, that the study presents “strong” evidence against the alleged link between vaccines and autism.

Conflicts of interest: At the time of publishing, seven of the eight authors were employees of the Danish Epidemiology Science Center research group, which has been awarded numerous generous CDC research grants since the year 2000. The group was headed by Danish researcher Poul Thorsen, who has been “wanted” since 2011 by the US Office of Inspector General. Thorsen, who is still a fugitive from justice,^[p3] was also a coauthor of the Madsen 2002 study. He was indicted for pocketing a substantial portion of the research budget allocated to the group by the CDC.³⁷ The Danish study group headed by Thorsen was highly productive, releasing a succession of epidemiological studies within a few short years whose findings were fully in line with the CDC’s official stance that vaccines do not cause autism or other neurological syndromes.³⁸ The eighth author of the paper, Diana Schendel, was a CDC employee.³⁹

The Madsen 2002 study was largely funded by a CDC grant.⁴⁰ At the time the CDC commissioned and funded the study, it was under intense public pressure due to parents’ claims that vaccines caused their children’s autism. The CDC categorically denied the link then, as it does today.⁴¹ Despite its supposedly neutral position as a government institution, the CDC has an obvious bias when it comes to vaccines. It is hardly surprising that the federal agency responsible for the childhood vaccination program firmly and consistently denies any link between vaccines and autism, as well as any link to other neurological and chronic disorders. A CDC-funded study proving a link between vaccines and autism, or even merely suggesting one, would likely spell disaster for the organization, not to mention open a Pandora’s box that could potentially obliterate the entire vaccine program.

Study flaws: The Madsen 2002 study demonstrates one of the methodological limitations of epidemiological research, namely its inability to provide conclusive results concerning rare phenomena. The IOM 2011 report alludes to this limitation, noting that “…studies […] can fail to detect risks that affect a small subset of the population.”⁴² Although Madsen 2002 examined the health records of over half a million Danish children, the relevant group – children diagnosed with autism – was comprised of only 263 kids vaccinated with MMR and 53 that were not.^[q3] Given such a small group of relevant subjects, the results are extremely sensitive to any errors or biases in data collection. Though the records of 537,303 subjects were inspected, the MMR status had to be incorrect for as few as 15 autistic children, a meager 0.003% of the study population, for the study results to be completely reversed. The fact that the results were so sensitive to such a small number of errors is a serious limitation that the authors seemed to be aware of and (partially) tried to address.

Of the myriad bits of information collected on the study subjects, there were two critical details that had to be correct in light of the discussion above: (a) whether the child was diagnosed with autism and (b) whether the child had received the MMR vaccine. In order to verify subjects’ autism classification, the researchers specifically examined a sample of the relevant registration files and concluded that they were reasonably accurate.⁴³ However, when it came to the second important detail – whether or not children had received the MMR – the researchers didn’t do any additional verification of the data. The subjects’ MMR vaccination status was taken from a national database that received notifications from family physicians after vaccinating children at their clinics.⁴⁴ Given the study question and context, underreporting of MMR vaccination would not be unreasonable. For example, a family doctor who vaccinated an infant with MMR at his clinic only to witness the child’s severe reaction could have chosen not to report the vaccination to the national database out of practical or emotional reasons. If the child were later diagnosed with autism, the missing MMR vaccination record would put the child in the unvaccinated autistic group, rather than the vaccinated autistic group. Rather than verifying their data, Madsen and colleagues noted that they “assume that the data on MMR vaccination are almost complete, since general practitioners in Denmark are reimbursed only after reporting immunization data to the National Board of Health.”⁴⁵ But in a study with such a small number of relevant subjects, where inaccuracies for only a handful of children would make such a dramatic difference, why didn’t the researchers make the extra effort to verify the MMR vaccination status? And how could anyone say the results of the study provide “strong evidence” when they rely entirely on the authors’ assumption that the relevant data was correct?

The questions regarding the researchers’ objectivity, given their conflicts of interest and negligent handling of vaccination data, become even more pronounced when considering the statistical methodology they used to obtain their results.

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46 Abbreviated Name: Madsen 2002
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Archive:
https://drive.google.com/open?id=1Yr4-bZH0ybUOZcp52BHoxzR_A1gjSSG6
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Data obtained from Table 2

What stands out in the Madsen 2002 study, quite astoundingly, is that the raw data plainly contradict the study’s conclusion. The Danish data, presented in Table 2 of the paper, actually show a 45% higher risk of autism in MMR-vaccinated children, compared to the non-MMR-vaccinated. Suspiciously, after the researchers manipulated the data, the trend was reversed to indicate an 8% lower risk of autism in the MMR-vaccinated children.⁴⁶ To repeat, while the raw data imply a higher risk of autism among MMR-vaccinated children, the study’s final results indicate the opposite.

How did the Madsen 2002 authors end up with a slightly reduced autism risk in MMR-vaccinated children, when the raw numbers showed a substantially increased risk? The answer is “adjustments”. The researchers statistically “adjusted”, i.e. manipulated, the raw data based on children’s characteristics such as age, gender, birth weight, and socioeconomic status.⁴⁷ What were the exact calculations applied in these statistical adjustments, and why were they needed? The authors provide no answers.

Omitting a detailed account of statistical “adjustments” from a published paper is not unusual in and of itself. Such details are rarely included in a published paper due to lack of space and readership interest. However, Madsen 2002 is different because the adjustments made to the raw data reversed the study outcome. Under such circumstances, it is appropriate, even imperative, for the authors to provide a reasoned and detailed explanation of their “adjustments” and to justify the reversal in their conclusion. But not only was no explanation provided, the authors also failed to mention that their adjustments reversed the conclusion that could be drawn from the raw data.

Summary: World-leading health organizations consider the 2002 Madsen study “strong” evidence of the absence of a link between the MMR and autism. The study was funded by the CDC, a staunch denier of the vaccine–autism link, which is hardly surprising given its role as the US’s primary vaccine marketer and defender. All authors save one, herself a CDC employee, belonged to a Danish research group that was established and heavily funded by the CDC and headed by a man who is now a fugitive wanted for fraud. Although the authors boasted that their study included more than half a million children, they did not bother to verify the single piece of information most crucial to the study’s validity – the MMR vaccination status of the autistic kids. This raises serious questions concerning the accuracy of the data as well as the researchers’ ethics. Even worse, it turns out that the study’s raw data actually indicated an increased risk of autism for children who had received the MMR, but the researchers managed to reverse this undesired association by performing undisclosed statistical manipulations.

DeStefano 2013: Vaccine Antigens and Autism
Paper name: “Increasing Exposure to Antibody-Stimulating Proteins and Polysaccharides in Vaccines Is Not Associated with Risk of Autism”⁴⁸
Journal and publication year: The Journal of Pediatrics, 2013
Lead author: Frank DeStefano
Type of study: Retrospective case-control study

Short description: A case-control study that compared the cumulative number of antigens in vaccines given to 256 autistic children with those received by 752 non-autistic children. The study found that the amount of vaccine antigens to which children were exposed in both groups was almost identical and concluded that increasing exposure to vaccine antigens was not associated with higher autism risk.⁴⁹

DeStefano 2013 is a classic example of a vaccine safety “spin study”, that is, a deliberately biased institutional study designed to provide a seemingly scientific answer to a popular vaccine criticism. In this instance, the argument, often brought up in vaccine online debates, was that infants receive too many vaccines and that their cumulative effect had never been properly studied. The paper’s publication was accompanied by a media campaign. The news media reporting on the study, assisted by the lead author, went out of their way to imply that science had thoroughly examined the above argument and found it to be false.

Conflicts of interest: The study was funded by the CDC.⁵⁰ Two of the three authors were CDC employees. The lead author, Frank DeStefano, is a veteran employee and senior CDC manager who had previously published several vaccine safety studies, all of which, unsurprisingly, found that vaccines are indeed safe.⁵¹ While working on this study, DeStefano headed the CDC Immunization Safety Office, and he still holds this position as of this writing.⁵² Given that any scientific finding disputing the safety of vaccines would hit the CDC’s Immunization Safety Office first, it is hard to think of a government official more likely to be conflicted with respect to vaccine safety than Frank DeStefano. If it ever became scientifically confirmed that vaccines did cause autism, public outrage, directed first and foremost towards the CDC and its Immunization Safety Office, would be enormous. But even though DeStefano and the agency he works for have the most to lose from studies criticizing vaccine safety, and even though both have been assuring the public for decades that “vaccines are safe”, DeStefano disingenuously declares in the paper that he has “no conflicts of interest”.⁵³

Media and establishment response: As soon as it was published, DeStefano 2013 received widespread exposure in the US media. News stories that appeared simultaneously in various media outlets were all beating the same drum: The new CDC study unequivocally refutes the parental concern that too many vaccines may cause autism. For example, the headline of the story that appeared on the NBC website read: “New study finds no link between ‘too many vaccines’ and autism.”⁵⁴ In the article, DeStefano himself was quoted as saying: “This study looked into the concern that receiving too many vaccines at one doctor’s visit or too many vaccines during the first two years of life may be linked to the development of autism. We found they’re not related.” The article also noted that DeStefano expressed hope that the new study would convince parents that there are no safety issues with the CDC’s vaccine program and they should vaccinate according to the official schedule. “The number of vaccines in the current immunization schedule is what’s needed to protect children,” he concluded. “It’s not too many for a child’s immune system.”⁵⁵ (The emphasis on the word vaccines above does not appear in the original piece. See explanation below).

Similar stories appeared in other mainstream media websites such as Forbes, TIME Magazine, National Public Radio (NPR), Medical News Today, and CBS.⁵⁶ All of the articles repeated the message that the study found no link between the multitude of child vaccines and autism, and that it provided further proof that vaccines are safe. All expressed a similar expectation that the publication of this study would ease parents’ concerns and lead them to resume vaccinating their children according to official recommendations. No outlet expressed any criticism of or even shred of doubt about the study, the vaccine program, or the CDC’s vaccine policy. The conflicts of interest of the main author and the funding agency were never mentioned.

And, of course, there wasn’t a single word about the awkward fact that the study didn’t actually investigate the question the media claimed it had definitively answered: Could “too many vaccines” be causing autism?

Study flaws: The emphasis on the word vaccines in the above quotations from NBC is meant to highlight the deliberate deception perpetrated by the study authors and their media collaborators. The reality is that DeStefano 2013 did not explore whether “too many vaccines” could lead to autism, but rather the supposed effect of “multiple antigens” on the development of autism (and its results are meaningless anyway, as shall be explained later). The paper’s title, as well as many other references in the text, explicitly states that it is the number of vaccine antigens that was examined,^[r3] not the number of vaccines.⁵⁷ The distinction between the two is important: The antigen, typically composed of fragments of bacteria or virus, is arguably the principal component of a vaccine, as it is the one that triggers an immune response intended to provide future protection from disease. However, the antigen is just one of numerous substances inside a vaccine vial. Vaccines typically contain a host of other ingredients that serve various functions, such as preservatives, stabilizers, adjuvants, and more. Some of these ingredients are known to be highly toxic (aluminum, mercury) or carcinogenic (formaldehyde). The adverse biological effects this conglomeration of biological and chemical ingredients could potentially have on an infant’s body have never been studied in depth, not individually and not in combination.

Thus, parents’ concerns do not focus specifically on the potential adverse effects of antigens, but rather on the full range of vaccine ingredients, including those known to be toxic or carcinogenic and those whose effect on an infant’s body has not been sufficiently studied. They worry that the growing number of vaccines recommended by the CDC exposes infants to a medley of foreign substances that could harm them. The antigen is but one of these substances, and not necessarily the most harmful.^[s3] Although DeStefano and coauthors seem well aware of this – stating that “a recent survey found that parents’ top vaccine-related concerns included administration of too many vaccines during the first 2 years of life”⁵⁸ – they nevertheless chose to investigate the association between the total amount of vaccine antigens and autism, rather than try to address the issue that is really concerning parents: the potential consequences of too many childhood vaccines. Why didn’t the authors address the link between the number of vaccines and autism and thus provide a direct response to the real parental concern? This question was never answered in the paper or in subsequent media interviews.

Putting aside the inappropriateness of the research topic chosen by government officials whose primary role is to oversee the safety of vaccines, an even more troubling aspect of DeStefano 2013 was the sly manner in which the media spun it. Though the link between vaccines and autism was never really explored by the researchers, the media, assisted by an eager DeStefano, was quick to oversell the study results as putting parental concerns to rest. As shown above, media headlines echoed the same counterfeit message, proclaiming that the study found “no link between the number of vaccines and autism.” Moreover, DeStefano, who as lead author surely knew better than anyone what the study was really about, shamelessly repeated this false narrative in some of the news stories.

We have established, then, that DeStefano 2013 did not investigate, or even attempt to investigate, the question attributed to it by the media and its lead author. Instead of exploring the link between “too many” vaccines and autism, as publicly stated, it really looked into a potential link between the number of antigens and autism. But what did the study really examine and what did it actually “prove”?

The researchers propose the total number of antigens in vaccines as a measure of the overall level of immune system stimulation, or immune system response, triggered by vaccination.⁵⁹ The validity of this proposition requires evidence in its own right, but the paper presents none. Moreover, its lack of validity becomes apparent when we look at how the cumulative loads were calculated: The researchers multiplied the number of antigens in each vaccine dose by the number of doses each child received for each vaccine administered in the first two years of life. This simplistic and crude calculation, which seems to have been invented specifically for the purpose of this study, is based on the unfounded and highly improbable assumption that disease antigens in different vaccines evoke equivalent immune responses. For example, according to the paper, the DTP vaccine with its 3,000 antigens presumably evokes an immune response 3,000 times greater than that of the hepatitis B vaccine, which contains just a single antigen.⁶⁰

In fact, the researchers are well aware that merely adding up the number of antigens in vaccines as a measure of immune response is nonsensical, and they point out some of its weaknesses, stating that “admittedly, this approach assumes that all [antigens] in a vaccine evoke equivalent immune responses,” and “moreover, the calculations do not take into account the number of epitopes per antigen or the immunologic strength of each epitope.”⁶¹ Despite the improbability of their assumption and its lack of scientific support, the researchers note that they “think” that their method provides a good estimate of the antigenic load of vaccines and proceed to examine its supposed effect on autism development.⁶²

Another glaring weakness of this “antigen counting” calculation, which the authors neglect to mention, is the role played by vaccine adjuvants. In some inactivated vaccines, the bacterial or viral materials that serve as antigens cannot, by themselves, elicit a sufficient immune response to prevent disease. In these vaccines, a substance called an “adjuvant” is usually added to the mix. The adjuvant stimulates the immune system so it responds to the antigen more intensely and for a longer period of time. Adjuvants can also be used to reduce the quantity of antigens required in some vaccines. Thus, the intensity of immune response to adjuvant-containing vaccines is largely dependent on the adjuvant used – its mode of action and its quantity – and less on the antigen itself. Therefore, in order to assess the strength of the immune response elicited by vaccines, whatever that actually means, one must include the adjuvant in the calculation in one way or another. Similarly, it is not unreasonable to assume that other vaccine ingredients may also affect the level of antigenic stimulation induced by the vaccine. Yet, despite the key role adjuvants play in the strength of immune response to vaccines, they are not even mentioned in the paper.

One might conclude, then, that the DeStefano 2013 study failed twice: Not only did it fail to investigate the real parental concern, the link between “too many vaccines” and autism, but also the question it did look into – vaccine antigenic load and its association with autism – was so simplistically and poorly studied its results are scientifically worthless.

One last point worth making regarding DeStefano 2013 is this: Even if we ignore the study’s glaring flaws, what did it actually find? The difference in the number of vaccine antigens to which the study subjects were exposed is largely due to the fact that the diphtheria-tetanus-pertussis (DTP) whole-cell vaccine was replaced with the newer acellular vaccine (DTaP) during the study period.⁶³ The older whole-cell vaccine contained over 3,000 antigens per vaccine dose, while the newer acellular vaccine contains only 4-6 antigens per dose.⁶⁴ This is the main reason behind the large differences in the cumulative number of antigens to which study subjects were exposed, as all of them, it seems, were vaccinated with one of these two vaccines.^[t3] That is, if there were an insight to be gained from the study results (ignoring its salient flaws) it would be this: The risk for autism did not significantly change for children vaccinated according to the recommended schedule after the DTaP vaccine replaced its DTP predecessor. Naturally, since the study population was quite small, this conclusion must be taken with a grain of salt.^[u3]

Summary: DeStefano 2013 is a classic example of a vaccine safety “spin study”. It was never intended to advance scientific knowledge but rather to be a battering ram for vaccine proponents to counter a specific claim often made by parents questioning the safety of vaccines. The study supposedly answered the parental concern that the large number of vaccines their children were receiving might have a negative impact on their health, and, specifically, might lead to autism. Yet the study didn’t investigate this hypothesis at all. Instead, the researchers chose to study the supposed effect of the total number of antigens in vaccines on autism development, using a dubious and scientifically baseless calculation. After reaching the desired result, the authors collaborated with the media to promote a false narrative to the public. Media news stories unanimously affirmed that DeStefano 2013 disproved the suggested link between “too many vaccines” and autism, though such a link was never even investigated.

The study was funded by the CDC and two of its three authors were CDC employees, including the lead author who was the head of the center’s Immunization Safety Office. This raises serious questions as to the ethical conduct of the governmental agency entrusted with vaccine safety. It is equally concerning that such a glaringly flawed study hasn’t drawn so much as a smidgen of criticism in medical and scientific circles.⁶⁵

Grimaldi 2014: Gardasil and Autoimmune Injury
Paper name: “Autoimmune Disorders and Quadrivalent Human Papillomavirus Vaccination of Young Female Subjects”⁶⁶
Journal and publication year: Journal of Internal Medicine, 2014
Lead author: Lamiae Grimaldi-Bensouda
Type of study: Retrospective case-control study

Short description: The study examined whether vaccination with the human papillomavirus (HPV) vaccine Gardasil is a risk factor for subsequent development of autoimmune diseases in girls and young women. The researchers compared the vaccination rate in a group of girls and young women with autoimmune diseases to the respective rate in a control group they selected. The rate of vaccination with Gardasil in both groups was similar, which led the researchers to conclude that the vaccine does not increase the risk of autoimmune diseases examined in the study.

Conflict of interest: A cursory glance at Grimaldi 2014 seems to indicate it is a standard academic study in the field of vaccines; most of its authors are either medical doctors or academics. However, the “Conflicts of interest” and “Funding” sections of the paper tell a different story. The study was funded by Sanofi Pasteur MSD,⁶⁷ a French company jointly owned by the pharmaceutical giants and vaccine manufacturers Sanofi Pasteur and Merck (known in Europe as MSD). The joint company is responsible for production and marketing of vaccines in Europe, including the Gardasil vaccine.⁶⁸ In addition to providing research funding, the company also paid the members of the scientific committee overseeing the study.⁶⁹ Furthermore, about half of the study authors had previously received grants and payments from numerous pharmaceutical companies, including the vaccine manufacturers Novartis, GSK, Merck, and Sanofi Pasteur.⁷⁰

Such a long and varied list of conflicts of interest typically raises questions about the researchers’ motives and their ability to be objective. However, in the case of Grimaldi 2014, the reality is even grimmer than usual. The paper’s “fine print” reveals that the study was actually conducted by a private company called LA-SER, and that its lead researcher (Grimaldi-Bensouda) and two other researchers (Rossignol and Abenhaim) were company employees (Abenhaim is also the company’s manager). LA-SER provides services and consulting to the pharmaceutical industry. Its website boasts that five of the world’s eighth largest pharmaceutical companies are clients. The company specializes in pharmacoepidemiology, the epidemiology of pharmaceutical products, and one of the services it provides is “cutting edge outcomes research designed to demonstrate the benefit to patients that products and health technologies provide.” In other words, the company sells epidemiological studies that make its clients’ products look good. As part of the service it provides, the company handles all aspects of epidemiological research, from designing studies to writing them up and submitting them for publication.⁷¹

It turns out, then, that the seemingly innocent academic study exploring the link between Gardasil and autoimmune diseases was actually commissioned and sponsored by the vaccine’s manufacturer and performed by a private company that specializes in delivering favorable epidemiological studies to its clients.

Media and establishment response: Unlike the previous two studies, Grimaldi 2014 did not receive much media attention. However, it did find its way into CDC publications. A weekly CDC report refers to the study as evidence of Gardasil’s safety.⁷² Another official document, a parent information leaflet recommending the vaccine published by the CDC and the American Academy of Pediatrics (AAP), also refers to Grimaldi 2014, among other studies.⁷³ Needless to say, these publications do not bother to mention that the study was ordered by the vaccine manufacturer and delivered by a private company that promises to make friendly pharma companies’ products look better.

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74 As of July 2020.
http://onlinelibrary.wiley.com/doi/10.1111/joim.12155/citedby

In addition to CDC publications, Grimaldi 2014 has been frequently cited in the medical literature since it was published. The paper is currently referenced by no less than 99 different medical publications.⁷⁴

Study flaws: Grimaldi 2014 is a retrospective observational study of the case-control type. In a case-control study, the researchers select a “case” group that includes subjects with a specific medical condition (e.g., men in their 50s who have lung cancer or girls with autoimmune disease), and a control group made up of subjects without the condition. Every subject in the case group is matched with one or more subjects from the control group, who have similar personal characteristics (age, gender, place of residence, etc.). The researchers then check the exposure of both groups to the factor under investigation (such as cigarette smoke or Gardasil vaccination). If the data indicate that the case group was significantly more exposed to that particular factor than the control group, this adds weight to the assertion that the factor is indeed a cause of the relevant medical condition. Thus, if the case group of men in their 50s with lung cancer had a much higher exposure to cigarette smoke than the healthy control group, this would indicate that cigarette smoke could well be a cause of lung cancer.

The obvious weakness of a retrospective case-control study is that it is fairly easy to skew its results by deliberately selecting control group members. For example, if the researchers wish to conclude that Gardasil does not lead to autoimmune disease, they can simply assign a high proportion of vaccinated women with no such disease to the control group. In this way, the condition investigated (autoimmune disease) would appear to not be affected by the factor considered (vaccination with Gardasil), as both case and control groups are highly vaccinated, though they differ in their autoimmune disease status. Such a research maneuver is not difficult to accomplish since a case-control study’s control group typically includes no more than a few hundred subjects usually drawn from a repository of tens or hundreds of thousands of individuals.^[v3] Because the researchers had full access to the data on the group with autoimmune diseases (the cases), they already knew the group’s Gardasil vaccination rate. Hence, they could easily have assembled a control group with a vaccination rate that matched or surpassed this number, while publicly declaring they had made a random selection.