Risks, Reactions and Revenue

Adverse reactions to vaccines are unacceptably common. Even the FDA admits that FluMist (the live-virus nasal spray vaccine) can cause pneumonia and “medically significant wheezing.” Neil Miller reports that “during pre-licensure clinical studies 3% of all children six months to one year of age who received the vaccine ended up in the hospital with respiratory problems!”

Before this vaccine was approved, a large study conducted in 31 clinics showed that it caused “a statistically significant increase in asthma or reactive airways disease” in children under five years of age. Nevertheless, in September 2007 the FDA licensed this vaccine for children as young as two years old.

With some vaccines, the number of people who experience systemic reactions, such as fever, headache, respiratory infection, muscle aches, nausea, abdominal pain, diarrhea, chills and fatigue, is very high.

For example, up to 10% of babies will vomit following their pneumococcal shots. A whopping 62% of 18-55 year-old recipients of the meningococcal vaccine had systemic reactions. Doctors consider most systemic reactions “normal.”

Common systemic reactions are separate from severe and fatal reactions, including neurological, immunological and paralytic disorders such as Guillain–Barré syndrome, demyelinating diseases, arthritis, anaphylactic shock, and other life-threatening conditions.

Vaccine injuries can often be “disguised” by labeling the conditions as learning disabilities, hyperactivity, mental retardation, attention deficit, etc. Many parents are completely unaware at how common these adverse reactions can be, let alone that they can occur at all.

According to a study published by Pediatrics, when parents were specifically asked to observe changes in their baby's behavior after a shot, only 7% reported no reactions at all.

Because of the public's general ignorance of the various types of possible damage that can result from vaccines, the true number of vaccine injuries may be vastly underreported.

According to this study:

In 1986, Congress passed the National Childhood Vaccine Injury Act (PL-99-660) requiring health care providers to report suspected vaccine reactions to a centralized reporting system. As a result, the Vaccine Adverse Events Reporting System (VAERS), cosponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), was established in 1990.

VAERS is a postmarketing safety surveillance program that collects information about possible adverse reactions (side effects) that occur after the administration of vaccines licensed for use in the United States. Current and historic VAERS data are public access, available to health care providers, vaccine manufacturers, and the general public.

VAERS receives approximately 30,000 reports annually. Since 1990, VAERS has received over 350,000 reports, most of which describe mild side effects, such as fever and local reactions.

About 13% of all reactions are classified as serious, involving life-threatening conditions, hospitalization, permanent disability, or death. By monitoring such events, VAERS helps to identify unusual patterns of reports and important safety concerns.

Our findings show a positive correlation between the number of vaccine doses administered and the percentage of hospitalizations and deaths.

Since vaccines are given to millions of infants annually, it is imperative that health authorities have scientific data from synergistic toxicity studies on all combinations of vaccines that infants might receive. Finding ways to increase vaccine safety should be the highest priority.

However, the FDA estimates that 90% of doctors don't even report reactions. Continuing from the study on VAERS:

Since VAERS is a passive system, it is inherently subject to underreporting. For example, a confidential study conducted by Connaught Laboratories, a vaccine manufacturer, indicated that “a fifty-fold underreporting of adverse events” is likely.

According to David Kessler, former commissioner of the FDA, “only about one percent of serious events [adverse drug reactions] are reported.”

According to Ottaviani et al., “Any case of sudden unexpected death occurring...in infancy, especially soon after a vaccination, should always undergo a full necropsy study,” otherwise a true association between vaccination and death may escape detection.

A recent study by Kuhnert et al. demonstrated a 16-fold increase in unexplained sudden unexpected death after the fourth dose of a penta- (5-in-1) or hexavalent (6-in-1) vaccine.

Similarly, Zinka et al. reported 6 cases of sudden infant death syndrome that occurred within 48 hours following the administration of a hexavalent vaccine. At postmortal examination, these cases showed “unusual findings in the brain” that appeared compatible with an association between hexavalent vaccination and sudden infant death syndrome.

These examples provide additional evidence that cases of vaccine-related mortality are likely underreported in VAERS.

According to Neil Miller, one of the authors of the aforementioned study, the federal government is aware of the unnecessarily high danger of many vaccines.

In fact, Congress established a “hazard” tax on childhood vaccines. When parents pay the doctor for requested shots, some of that money goes into a special fund to compensate them when their children are seriously damaged or die.

As of September 2009, nearly $2 billion was granted for thousands of injuries and deaths caused by mandated vaccines. Numerous cases are still pending. Awards were issued for permanent injuries such as learning disabilities, seizure disorders, mental retardations, paralysis, and numerous deaths, including many that were initially misclassified as sudden infant death syndrome (SIDS).

Parents need to understand that vaccines are drugs. Each one contains a proprietary blend of chemicals, pathogens and other foreign matter. That is the nature of a vaccine.

Today, children receive one vaccine at birth, eight vaccines at two months, eight vaccines at four months, nine vaccines a six months, and twelve additional vaccines between 12 and 18 months (DtaP and MMR are each given with a single injection but contain three vaccines).

The United States is the most vaccinated country in the world, yet it has a poor infant mortality rate. One would think that a country with more immunizations, which are explicitly promoted as life saving, especially for babies, would have an excellent infant death rate...as new vaccines are added to the recommended vaccine schedule, the US infant mortality rate worsens.

In 1960 (before mass vaccines) the US had one of the best infant mortality rates in the world. By 1998, the US dropped to 28th place. By 2006 [the US] fell to 42nd place, worse than Cuba but ahead of Croatia.

Interesting that Croatia would be so low on that list as well, as their policy towards vaccinating infants was made very clear by recent legislation forcing all parents to vaccinate, a disturbing decision that was even more disturbingly lauded by those who think the vaccine debate is only about “autism.”

However, Miller is quite clear that vaccination does prevent disease...the tragedy is that greed and conspiracy have created a system that is becoming increasingly difficult to trust.

If you choose not to vaccinate, there are risks involved. Your child could contract a disease for which a vaccine has been developed. Your child may also experience complications form this disease, which could be permanently debilitating or life-threatening, depending on the particular condition and other factors, such as the child's physical constitution and its ability to reestablish health.

Not vaccinating is just one risk; vaccinating is another...diseases are described in frightening detail and their risks exaggerated beyond reality.

With vaccines (and many drugs as well) the “solution” is often developed prior to the marketing of fear. For example, before the chickenpox vaccine was licensed for general use in 1995, doctors would encourage parents to expose their children to the disease while they were young. Doctors recommended this course of action because they knew that chickenpox is relatively innocuous when contracted prior to the teenage years, but more dangerous in adolescents and adults.

  

It wasn't until after the vaccine was licensed that the CDC began warning parents about the dangers of chickenpox. Many doctors soon stopped encouraging parents to expose their children and instead receive the shot. The “solution”—a vaccine—preceded the apparent danger.

           

Vaccine efficacy can be specious.

For example, scientists presume that certain “surrogate markers” or “precancerous lesions” precede cervical cancer. With the HPV vaccine, they simply compared the numbers of these markers in women who received the vaccine to the numbers of these markers in women who received the placebo. However, no actual cases of cervical cancer were prevented in any of the test subjects in any of the clinical studies of the HPV vaccine.

The HPV vaccine was marketed deceptively as well when first introduced, being promoted as “100%” effective. However, the vaccine is only “100%” effective against two of numerous strains of HPV, not cervical cancer itself.

During prelicensure studies, 361 women who received at least one shot of Gardasil went on to develop precancerous lesions on their cervixes within three years.

According to the report HPV Vaccination – More Answers, More Questions: “cautious approach may be warranted in light of important unanswered questions about overall vaccine effectiveness, duration of protection, and adverse effects that may emerge over time.”

In this 2007 report commissioned by the NEJM, two studies were considered on the vaccine's effectiveness on cervical cancer. The report asked: “In these trials, called Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I and II, what is the efficacy of vaccination among all subjects, regardless of causal HPV types?”

The results were not promising, as it was determined that in FUTURE I that the vaccine had an efficacy of only 20%, and this was only against low-risk lesions: “no efficacy was demonstrable for higher-grade disease, but the trial may have lacked adequate power to detect a difference.”

However, the larger FUTURE II had more conclusive, and even less favorable, results, as the vaccine was only 17% effective, and again had no impact on preventing high-risk lesions. The report mentions the obvious shortcomings of the vaccine:

Another factor explaining the modest efficacy of the vaccine is the role of oncogenic HPV types not included in the vaccine. At least 15 oncogenic HPV types have been identified; so targeting only 2 types may not have had a great effect on overall rates of preinvasive lesions.

This concept of “strain replacement” is not limited to the HPV vaccine, and is an extremely important aspect of the vaccine debate that deserves more attention. Miller continues:

Gardasil is not the only vaccine that targets some strains of the disease while excluding others. The Hib and pneumococcal vaccines were also constructed in this manner, and have become problematic due to “strain replacement.”

Scientists have discovered that when vaccines only attack some strains of a disease, other strains gain prominence. The disease becomes more virulent and people who are normally not susceptible to the ailment are infected.

For example, there are several different types of haemophilus influenzae, including types a, b, c, d, e, and f. The “b” type is just one strain—the only one for which a vaccine was created—the Hib shot. Although this vaccine appears to have decreased cases of haemophilus influenzae type b in children, the overall rate of invasive haemophilus influenzae disease in adults increased.

Researchers don't consider this a failing of the Hib vaccine, rather “it raises the question whether a [new] vaccine will need to be developed.”

Prevnar, the pneumococcal vaccine, is only designed to protect against a few of the 90 different strains that can cause the disease. The vaccine is therefore still considered “effective” if the child is stricken with pneumococcus...just not from one of the strains included in the vaccine.

The Journal of the American Medical Association and the Pediatric Infectious Disease Journal have both published data demonstrating that non-vaccine strains of pneumococcus are replacing the strains targeting by the vaccine. What's even more concerning is the new strains are more dangerous and drug-resistant. According to the study Pediatric Invasive Pneumococcal Disease in the United States in the Era of Pneumococcal Conjugate Vaccines:

Through the widespread use of PCV7 in the United States, there has been a significant decrease in the incidence of IPD and nasopharyngeal carriage of vaccine serotypes in all age groups. However, the emergence of replacement pneumococcal serotypes (e.g., 19A, 1, 5, 15, and 33) is now having a significant impact on the success of PCV7.

These serotypes have become the most common causes of IPD in infants, children, and adults, with serotype 19A having emerged as the predominant replacement serotype associated with multidrug-resistant infections.

   

Another concern is when vaccines are given to one group with the hope of protecting another group. Miller explains:

Mass rubella vaccination campaigns were never intended to protect vaccine recipients; the disease is usually harmless when contracted by children. Instead, the goal has always been to protect the unborn fetuses of rubella-susceptible pregnant women.

When the hepatitis B vaccine was originally introduced, this same rationale was employed. Children rarely develop this disease. In the US, less that 1% of all cases occur in persons less than 15 years of age. The disease is even more uncommon in babies and toddlers. However, “because a vaccination strategy limited to high-risk individuals has failed,” and since children are “accessible,” they are compelled to receive the three-shot series beginning at birth.

Some studies show that hepatitis B vaccine recipients lose protective antibodies after 5 to 10 years. The vaccine that babies receive shortly after birth at the hospital will not be effective a few years later. “By 5 to 15 years after vaccination, some individuals have antibody levels below the protective threshold—and in some cases even undetectable.”

The necessity for multiple “booster” shots is disturbing. Initially, when a new vaccine is introduced, a single shot may be recommended, Later, when the artificial immunity wears off, vaccine manufacturers and the CDC recommend one or more additional shots.

With natural immunity, which is acquired by being exposed to the actual disease, protection is not meager and temporary, but rather complete and lifelong. The child will rarely contract the disease again. This is not true with vaccines. Isn't it odd that the vaccine industry's answer to an ineffective vaccine is to compel more of it?

Another example of the strange logic employed by the media and many vaccine enthusiasts is the hysteria surrounding blaming those who are unvaccinated when there are outbreaks of disease.

Unvaccinated children are often sent home form school during outbreaks of measles, mumps and other contagious diseases. Ironically, these children are not sent home for their own protection. On the contrary, doctors claim that unvaccinated children will spread disease.

Of course, this does not make sense (unless we consider it a veiled confession of vaccine inefficacy). How is it possible for an unvaccinated child to imperil vaccinated children? If the shots are effective, then vaccinated children should be protected.

Miller continues by stressing that even members of the U.S. government are aware that the current vaccine program has many shortcomings, as well as the uncomfortable fact that some members of the FDA and CDC have extremely suspect financial interests.

Hearings are regularly held to highlight problems with individual vaccines as well as to investigate the integrity of the vaccine program itself...Members of the exclusive FDA and CDC committees that are responsible for licensing and recommending vaccines for all children in the US are permitted to have financial stakes in those vaccines.

For example, in 2000, a congressional hearing before the Committee on Government Reform was held called Conflicts of Interest in Vaccine Policy Making. The tone of the hearing was set in the opening statements, when it was announced that they needed to determine if “the entire process of licensing and recommending vaccines” has been polluted and the public trust has been violated.

Recent revelations about questionable tactics to approve the first rotavirus vaccine prompted the hearing. It was suspected that members of the FDA and CDC knew about the dangers of the rotavirus vaccine before approving it and recommending it for every child in the country.

Dr. Kathryn Edwards, a physician on the FDA's committees that voted to recommend the vaccine, received $255,000 a year from Wyeth-Lederle, the making of the vaccine. This fact was also cited in the 2000 congressional hearing.

Dr. Paul Offit, who was on the CDC's committee that recommended the vaccine, also held a lucrative patent on another rotavirus vaccine under development. “In addition, [Offit] was paid by the drug industry to travel around the country and teach doctors that vaccines are safe.”

Indeed, even within the last few months, Offit has made appearances on numerous talk shows, both TV and radio, bemoaning those who dare to question vaccines. The vast majority of the time he specifically mentions only “autism” and how ignorant the “anti-vaxxers” are for being afraid of “autism.” Instead of educating, he is continuing to restrict the conversation by completely omitting all of the concerns outlined so far, among many others.

One of the more striking things revealed by this hearing was with regards to the FDA and CDC advisory committees that voted to recommend adding the rotavirus vaccine to the childhood vaccination schedule. A whopping 60% of the FDA advisory committee and 50% of the CDC committee had financial ties either to the drug company that produced the vaccine or to Merck and SmithKline Beecham, two other companies developing potentially lucrative rotavirus vaccines.

During the hearing, Congressman Dan Burton had this to say:

Families need to have confidence that the vaccines that their children take are safe, effective and very necessary. Doctors need to feel confident that when the FDA licenses a drug, that it's really safe and that the pharmaceutical industry has not influenced the decision-making process.

Maintaining the highest level of integrity over the entire spectrum of vaccine development and implementation is essential. No individual who stands to gain financially from the decisions regarding vaccines that may be mandated for use should be participating in the discussion or policymaking for vaccines.

One would think, in the face of waning public confidence in the entirety of the vaccine program, that the FDA and CDC would take the opportunity to agree with such a rational request and restore the confidence of Congress and the public. Sadly, the response was quite the opposite.

On August 24th, 2000, Reuters Medical News published an article called “Congressional report slams FDA, CDC policies on disclosing financial conflicts.” The article describes how Linda Suydam, the senior associate commissioner at the FDA, stated quite unequivocally that “Both the law and policies allow us to use people who have financial ties.” Both the CDC and the Department of Health and Human Services (HHS) were also unwilling to make any of the recommended changes.

The rotavirus vaccine saga continued when a 2006 study was used by the FDA and CDC as a basis for licensing and recommending a new vaccine called RotaTeq. Neil Miller explains the obvious conflict of interest:

Authors of the study included Paul Offit and H. Fred Clark, co-owners of the patent on this vaccine (along with Dr. Stanley Plotkin). In addition, several other members of the study team who were supposed to be objectively evaluating the safety and efficacy of this vaccine, were paid consulting fees, lecture fees, and/or provided grant support by Merck, the vaccine manufacturer, or by GlaxoSmithKline, the maker of another rotavirus vaccine soon to be approved as well.

Some study team members even owned stock in Merck, whose equity value would increase by positive evaluations of this vaccine. Apparently, such conflicts of interest were deemed irrelevant to the impartiality required to ensure the integrity of the entire vaccine approval process and the safety of millions of babies who would soon receive this new vaccine.

The vaccine market is shifting towards adolescents and adults as well. According to a June 17th, 2007 article published by Genetic Engineering and Biotech News, “at present, pediatric vaccines occupy a higher market share, but this trend will shift towards the adult vaccine segment.”

Naturally, the US is the largest market for vaccines because they are “more profitable than generic pharmaceutical drugs.”