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Part 3: Flu Vaccines: Are They Safe & Effective?

By Richard Gale and Gary Null, PhD.
http://educate-yourself.org/vcd/nullandgalefluvaccines3part28sep09.shtml
September 28, 2009

Flu Vaccines: Are They Safe & Effective? Part 3 by Richard Gale and Gary Null (Oct. 14, 2009)

Part 3

Is The Flu Vaccine Effective?

There is no better place to begin a discussion on the effectiveness of the flu vaccine than to introduce a statement on Canada’s Vaccination Risk Awareness Network (VRAN) website, a community of physicians, researchers and vaccine scholars who report vaccines’ flawed promises and pseudo-science. Among all vaccines, the flu vaccine is listed as “The Most Useless Vaccine Of-All-Time Award.” CDC officials are even forced to confess that “influenza vaccines are still among the least effective immunizing agents available, and this seems to be particularly true for elderly recipients.”48 Dr. Anthony Morris is a distinguished virologist and a former Chief Vaccine Office at the FDA. His views regarding the flu shot go much further. There is no evidence that any influenza vaccine thus far developed is effective in preventing or mitigating any attack of influenza,’ Dr. Morris states, “The producers of these vaccines know they are worthless, but they go on selling them anyway.”49

Before every flu season, the Federal health agencies and HMOs commence campaigns encouraging flu vaccination. More effort goes into advertizing, promoting, and deliberating state policies for influenza than any other vaccination. Therefore we find individuals such as Dr. Marie Griffin, a consultant for the large vaccine manufacturer Burroughs Welcome, leading public relations campaigns to encourage flu vaccines on children. Who is Marie Griffin? Now an Associate Professor of Preventative Medicine at Vanderbilt University and an independent researcher ties to the Burroughs Welcome Fund, Dr. Griffin a principal researcher and author of flawed studies to supposedly exonerate the pertussis vaccine from earlier scientific evidence showing it caused neurological damage.50

A discussion on a vaccine’s effectiveness needs to first emphasize that vaccine theory has basically remained unchanged since Dr. Edward Jenner first inoculated a person with a smallpox virus at the end of the seventeenth century. The only essential knowledge a layperson requires to understand vaccination is that a virus is intentionally introduced in the body in order to stimulate the body’s immune system to produce its own antibodies to fend off the virus in the wild. Today, there are other measuring factors being used to determine how much of an immune response is being triggered and then other predictive calculations to determine whether or not the response will be effective enough to ward off infection. Nevertheless, the entire basis for vaccination relies solely on the introduction of a virus to the body. Another difference today is that vaccines can have a live virus, an attenuated virus or an inactive virus. We are told that some of these viruses are “killed”, but in fact, you can never fully kill a virus. Even a so called “killed virus” still presents its genetic code in the body and it is well known throughout the community of virologists that inactive or killed virus can reactivate. Live virus vaccines are little different than that used by Jenner. Attenuated viruses are live viruses that have been weakened. This means that parts of the virus have been more or less weakened.

When a virus is administered, the immune response becomes over-stimulated to produce antibodies. One of the issues of vaccine medicine that has remained unexplored, an issue the pro- vaccine establishment very likely wishes to ignore, is that whenever the body’s immune system is over-stimulated—the ultimate mission of a vaccination in order to stimulate protection against a virus—any other viruses, and bacterium, present in the body, which may or may not be dormant, could enter a hyperactive state and subsequently pose a new threat in the body. This is one reason why we so often hear people saying that after they have been vaccinated they feel sick and that they repeatedly have bouts of viral infection.

The CDC recommendations for the launch of the new swine flu vaccine include children starting at age six months. For years, seasonal flu vaccinations have been recommended to commence at six months. All of the recently FDA-approved intramuscular swine flu vaccines comprise an inactivated virus. So is there any evidence that inactivated viral H1NI and influenza vaccines are effective and safe in very young children? After examining exhaustive studies, we have not

The authors of the study had also contacted the lead scientists or research groups for all the efficacy and safety trial studies under their review in order to gain access to additional unpublished trial studies the corporations may possess. The conclusions are shocking. The only safety study performed with an inactivated flu vaccine was conducted in 1976. Thirty-three years ago! And that single study enrolled only 35 children aged 12-28 months. Every other subsequent inactivated flu vaccine study involving children enrolled children 3 years or older. come across such evidence. Some of the most damning evidence was reported in two studies performed by Dr. Tom Jefferson, head of the Vaccine Field group at the prestigious independent Cochrane Database Group, published in The Lancet and the prestigious Cochrane Database Systems Review. The first study was a systematic review of the effects of influenza vaccines in healthy children.51 The other was a review of all the available published and unpublished safety evidence available regarding the flu vaccine.52

Dr. Jefferson also told Reuters, “Immunization of very young children is not lent support by our findings. We recorded no convincing evidence that vaccines can reduce mortality, [hospital] admissions, serious complications and community transmission of influenza. In young children below the age of 2, we could find no evidence that the vaccine was different from a placebo.”53

Both studies also investigated evidence of live flu vaccine safety in studies with children This is especially relevant today because Medimmune’s approved nasal vaccine for the H1N1 swine flu uses a live virus. As for live virus flu vaccines, no safety studies have been performed on children younger than 22 months. Medical reporter for the Philadelphia Examiner, Deborah Dupre, states, “Non-governmental organization, intellectually honest health professionals agree that a person vaccinated with a novel A H1N1 live virus rather than inactive component viruses is contagious.” National Vaccine Information Prevention founder and president Barbara Lo Fisher concurs: “The live virus activated vaccine has the ability to spread flu.”54

Medimmune, the sole manufacturer of the live flu nasal vaccine, repeatedly refused to give unpublished data to Dr. Jefferson without executive clearance. The was also true for some vaccine makers working with inactive virus.

The reviewers’ final assessment quotes from another group of vaccine investigators who share similar views:

“we are concerned by our findings of limited clinical trial evidence for inactivated vaccines. In addition, the withholding of safety data for live attenuated vaccines makes it impossible to present a complete evidence base of their safety. Although a frequent practice, lack of reporting of non-significant outcomes raises the real possibility that our review may present a biased picture.”55

In another article, Dr. Jefferson summaries his main points concerning flu vaccines as follows:

• Evidence from systematic reviews show that inactivated vaccines have little or no effect on the effects measured

• Most studies are of poor methodological quality and the impact of confounders is high

• Little comparative evidence exists on the safety of these vaccines.56

Dr. Jefferson concludes, “We believe all unpublished trial safety data should be readily accessible to both the regulatory bodies and the scientific community on request. Our evidence gives rise to a concern that lack of access to unreported data prevents published data being put into context and hinders full and independent review. This cannot be good for public confidence in these vaccines.”57

Independent vaccine investigators and scientists, with no vested interest in the vaccine industrial complex, and who wish to uphold the highest standards of scientific integrity, are faced with great resistance and are basically hamstrung to procure necessary scientific and clinical trial data from the vaccine industrial complex and their federal guardians in order for them to conduct their research thoroughly. Federal agencies do not regulate what a corporation does or does not do with all of its clinical data on vaccine efficacy and safety. All that is required from vaccine makers is the necessary documentation required for FDA submission in order for approval and registration. All other data is a sealed proprietary vault off-limits to the rest the world’s scientific community unless such wishes for access be sanctioned by the corporations. This in itself is a violation of the highest ethics of true medical science, which by definition should be a quest for discovering and confirming medical facts and by sharing information publicly so scientists can further their knowledge to find the best solutions for tackling our health problems and solutions for them.

Australian scientist and vaccine expert, Dr. Viera Scheibner, has investigated the criteria vaccine makers use to conduct human trials to determine a vaccine’s safety and the means by which they determine their results. Vaccine makers use an “exclusion criteria.” If the same data were calculated under a different set of guidelines, particularly guidelines requiring double blind studies and true placebos, the results could be dramatically different. As an example, Dr. Scheibner shows how children in a MMR vaccine trial developed measles after injection were then able to be excluded from the final calculations based upon the company’s safety criteria. Unfortunately, her investigations show that this practice is “unashamedly” repeated time and time again by vaccine makers during clinical trials.

One excellent example is measles. Measles would have very likely disappeared on its own due to better sanitation, nutrition and cleaner resources. By the time the measles vaccine was first launched for mass immunization, measles infection had already decreased 90 percent. Opponents of the measles vaccine, who have shown that vaccination actually perpetuates the virus, point out studies performed among the Amish people living in small communities in the United States. There were no reports of measles among the Amish between 1970 to 1987. Then on December 5, 1987, there was a large outbreak of measles, at the time that the pro-vaccine establishment was claiming victory over this infectious disease and contributing it to vaccination. Dr. Scheibner has studied this phenomenon extensively, and concludes that it was the vaccine that kept measles alive.58 When asked:

“ 'Are vaccines effective?' [In my opinion they are] Definitely not. They are only effective in creating harm, damage to organs in the body. They cause all those modern ills of humanity, all those autoimmune degenerative diseases…. And it is all published and refereed in medical journals. So the evidence is right from the horse’s mouth.”

A scientific study in review for peer-reviewed publication was reported on CTV, Canada’s largest private television network, on September 23, 2009. The study, conducted in three Canadian provinces—British Columbia, Ontario and Quebec—by Toronto’s Mount Sinai Hospital, raises serious concerns over the potential efficacy of the new H1N1 flu vaccine based upon new data showing that a person vaccinated with last year’s seasonal vaccine are more susceptible to contracting the H1N1 virus. Because of the critical questions being raised about the lack of safety trials that have been undertaken for the H1N1 vaccine, the researchers considered their findings an urgent warning before the vaccine is launched on the public.
Moreover, there remains uncertainty over the concurrence of both H1N1 and the regular seasonal flu this Autumn. Canadian officials are even now discussing the possible need for small children to receive four flu vaccinations to cover each stain.59

The Toronto study raises a fundamental question that has not been addressed previously. First, to date, no clinical trials have been conducted to determine how the swine flu vaccine will interact with other flu shots. Second, there are no studies to ascertain whether or not the swine flu vaccine will make recipients more susceptible to infection from other flu strains. What the study does assure us is that influenza vaccines are interfering with the body’s natural immunity. In fact this study is showing a causal relationship between the influenza vaccination given to a depressed immune system and the increase likelihood that the individual will contract another wild flu virus.

The vaccine industrial complex frequently attempts to inflate vaccines’ benefits by tacking on other medical indications it will protect for. Although there is strong evidence that vaccinations may contribute to the ever-increasing rise in ear infections that countless parents experience repeatedly with their small children, vaccine makers want to convince us that flu vaccines may prevent ear infections. Buried in unpublished papers is a study presented to the 2002 meeting of the Pediatric Academic Sciences involving 793 children aged 6 to 14 months. The study found that there was no decrease in ear infections, doctor visits, ER visits, antibiotic prescriptions or missed daycare days between those children who received the vaccine and those who received placebo (meaning the vaccine without the viral component). However, every child in the study, had doctors’ visits throughout the season. While this might dispel the vaccine industry’s claims that the flu virus might cause ear infections, there is an obvious flaw. All children in the study received the same non-viral ingredients—adjuvants, thimerosal, and other chemicals—which contributed the children’s infections and physician visits.60

Over the decades I have interviewed many of the world’s most knowledgeable vaccine scientists, researchers and physicians working with children who have been victims of vaccination. Among the questions I routinely ask, is whether or not there is any evidence that vaccine makers conduct randomized double-blind placebo studies to determine efficacy and safety. Throughout true science, this protocol has served as the gold standard. And never have I ever heard anyone in the entire medical community, nor any of my own research, say they found evidence for randomized double-blind placebo studies ever being conducted in vaccine trials.

The use of placebos most commonly used in vaccination trials is exceedingly important. In standard scientific methodology a placebo should be a very inert substance, such as water or a sugar, in order to accurately determine the tested substance’s effects on human biology. According to world vaccine expert Dr. Viera Scheibner, vaccine trials do not employ an inert placebo. Instead, what is used as a placebo is “the vaccine with all the adjuvants and preservatives, certainly not inert substances, minus those viruses and bacteria… That is why when they compare the trial children who were given the lot and those who were given placebo, they have the same rate of reaction.”61 These means that almost all vaccine efficacy and safety trials using a non-inert placebo are based on scientifically flawed design from the start. It is therefore evident that flawed methodology will inevitably result in flawed data. Yet that is the guiding principle the vaccine industrial complex relies upon, and our federal health establishment is all too ready to give a nod of approval and allow it to continue.

During the 1980s, Japan had mandatory flu vaccination for school children in school. Two large scale studies that enrolled children from four cities with vaccination rates between 1 and 90 percent discovered there was no difference in the incidences of flu infection. As a result, in 1987, Japanese health authorities ruled that flu vaccination was ineffective and was no more than a serious liability if it was to continue. Therefore, the mandatory policy was quickly overturned.

By 1989, the numbers of Japanese taking the flu vaccine dropped to 20 percent. A follow up study at that time found that there was statistically insignificant change in influenza infection rates compared to when the vaccine was mandatory.62 The vaccine industrial complex makes the claim that flu vaccination will reduce asthmatic attacks brought on by flu infection among those children who are susceptible to them. A study by Dr. Herman Bueving at the Department of Family Practice at Erasmus University Medical Center in Rotterdam, Netherlands, conducted one of the few randomized, double-blind placebo studies found in vaccine literature. The two-year study enrolled 696 asthmatic children, half vaccinated and the rest administered a placebo. The study found there was no difference between the number and severity of asthmatic attacks between the two groups. This study gives further support in flu vaccination’s ineffectiveness.63

Vaccines are even shown to be less effective among the elderly, people over 65 years of age. Nevertheless, this age group is one of the primary targets for the swine flu vaccine, as it has been with other flu vaccines each season. Even the CDC acknowledges this fact. There have been many studies conducting in nursing homes to determine how effective flu vaccines are in preventing infection. Average effectiveness, meaning only to stimulate an adequate immune response, are in the low to mid twenty percent range (21-27 percent). Another set of four studies indicate the flu vaccine was 0, 2, 8 and 9 percent effective.64 Yet despite some of these dismal results, the CDC still wishes us to believe that vaccinating elderly citizens is “50-60% effective in preventing hospitalization and pneumonia and 80% effective in preventing death.65

Government health projections confirm, and the CDC has had to acknowledge this, that elderly people, with or without the flu shot, show less than a one percent rate of being hospitalized for pneumonia and influenza. That means that 99 percent of elderly people manage to weather the storm.66

In recent years we are now seeing supposed scientific studies emerging that are nothing more than commercials, public relation spectacles, to promote vaccination’s efficacy. Such studies either remain unpublished or are reinvented for publication well after the fact. Their sole purpose is to confuse a negative with a positive twist. They are no more than promotional spins designed by the vaccine industrial complex, and their cohorts in other private health sectors, to support their financial interests. In turn, they are used as a means to influence the nation’s health policy makers, relieve any doubts concerning their vaccine’s efficacy and safety. The nation’s health agencies then rely on these fabrications to convince the larger public healthcare community and citizens about the importance of being vaccinated.

Edward Yazbak, MD, an independent vaccine researcher and an expert in autoimmune regressive autism injury, did a thorough review of one such study entitled “Effectiveness of the 2003-2004 Influenza Vaccine Among Children 6 Months to 8 Years of Age, with 1 vs. 2 Doses”. After his analysis of the study’s data, he voted it “Most Creative Title of the Year.” The completely flawed study was meant to serve two fundamental purposes. First, to show flu vaccine’s efficacy, and second, to send a message that one dose was inadequate and two inoculations should be recommended in the vaccine schedule. Although the lead researcher Dr. Debra Ritzwoller and her colleagues claim in the document that they had no conflict of interest, they were employees of a large HMO, Kaiser Permanente. Dr. Ritzwoller is an economist specializing in health services. Two other researchers worked for the National Immunization Program. The study was eventually published more than a year later in the November 2005 issue of Pediatrics. In the document’s footnote, the study was first presented to the July 2004 meeting of the Advisory Committee on Immunization Practices (ACIP), an entity under the CDC. Therefore, it never went through peer-review before presentation to our nation’s highest advisory group making the crucial decisions on vaccine policy recommendations.

The study enrolled 29,726 children in the Denver area, 5,142 who were 6 to 23 months old. While this figure may appear impressive, Dr. Yazbak makes the acute observation that “figures in the thousands or millions in medical writings always raise a red flag for me” and in almost all cases with studies of this magnitude, they represent a “smokescreen.” Studies of this size simply cannot execute sound scientific inquiry nor perform proper due diligence to arrive at any conclusive information. He also noted a peculiar timing between when the study was conducted and an earlier Colorado study by the same group of researchers, which remains unpublished, and reported to the CDC’s Mortality and Morbidity Weekly Report (MMWR). Both were sequentially and perfectly timed between the new recommendations to vaccinate children in the 6-23 month range and the beginning of the 2004 flu season.

As a result of Ritzwoller and her team’s data, the ACIP declared, vaccination of children 6 to 23 months of age decreased hospitalization rates. However, the study never tracked any hospital admissions of the enrolled children. Later, a separate medical investigator queried the study’s lead author, Dr. Ritzwoller, on whether the flu vaccine caused any adverse reactions. By her own admission Ritzwoller stated there were none, but that “hospital admissions were not tracked, and the parents were not interviewed.”67

In a curious twist of fate, corporations, far removed from drug and vaccine development, but also obligated to test and market their own products, conduct studies that contradict the dogma of the pharmaceutical industrial complex. Procter and Gamble have conducted numerous studies on their common household products such as soap and liquid detergents. One such study was a randomized, placebo study of 611 hundred households, in 36 separate neighborhoods, in Karachi, Pakistan to determine whether frequent use of a common hand soap, an antibacterial (promotional) soap and a placebo soap would reduce the rate of lung infections due to pneumonia among children. Trainers visited each family weekly to educate and teach proper hand washing use and personal hygiene. When we review below the FDA’s and CDC’s flawed methodology for promulgating their myth that 36,000 Americans die annually from flu infections, we will see that over 90 percent of these mortalities are a result of pneumonia infections, not the influenza.

Proctor and Gambles results are quite startling with a fifty percent lower incidence of pneumonia infections among children under five with the plain and antibacterial soaps compared to placebo. There was also a 53 percent reduction in diarrhea and a 34 percent decrease in incidences of impetigo. While this may appear to be an irrelevant example, it is not off the mark. Dr. Ton Jefferson, head of the Cochrane Vaccine Field at the Cochrane Database Group in Rome, who has performed some of the most extensive analysis in the efficacy of flu vaccination during the course of the past 37 years, arrived at the conclusion, “People should ask whether it’s worth investing these trillions of dollars and euros in these vaccines.. What you see is that marketing rules the response to influenza and scientific evidence comes fourth or fifth. The best strategy to prevent illness is to wash your hands.”68 69

And if you are among those who would hold Dr. Jefferson suspect, then even the FDA’s and CDC’s 1999 directive to manufacturers to remove mercury from vaccines recommends that the safest and most effective way to prevent flu infections is frequent hand washing and a healthy lifestyle.70

An equally disturbing scenario unfolds about efficacy and safety trials conducted with pregnant women. In 2001, the CDC started to recommend the flu vaccine to all pregnant women. Eight years later, pregnant women are now being targeted as a priority group for the H1N1 vaccine. Nevertheless the vaccine is a Category C drug; which means there are no adequate safety studies after two studies published in 1973 and 1979 to determine hether flu vaccination adversely affects pregnant mothers and their fetuses.71 What remains utterly amazing is that many serious questions about live flu vaccines remain unanswered. Most shocking is the uncertainty as to whether the vaccine itself, having been administered nasally, might not transmit contagious infection in others. Worse is the lack of studies to determine the possibility of a serious immunological threat when an attenuated virus, which replicates more rapidly, is administered to individuals with compromised immune systems.

An important Dutch study was conducted in a large home for the elderly. In spite of two thirds of them having been vaccinated, the flu infected 49% of them, including bacterial and pneumonia infections, and 10% died. The critical observation found in the study was that 50% of those vaccinated got the disease whereas 48% of non-vaccinated people were infected. The results of this study clearly show that vaccination was useless.72

Dr. Sherri Tenpenny reviewed The Cochrane Database of Systematic Reviews to analyze the efficacy of flu vaccines. Below is a summary of her analysis.

• In a review of more than 51 studies involving over 294,000 children, there was “no evidence that injecting children 6-24 months of age with a flu shot was any more effective than placebo.

• In children over 2 years of age, flu vaccine effectiveness was 33 percent of the time preventing flu.

• In children with asthma, inactivated flu vaccine did not prevent influenza related hospitalizations in children. The database shows that children who received the flu vaccine were at a higher risk of hospitalization than children who did not receive the vaccine. In a separate study involving 400 children with asthma receiving a flu vaccine and 400 who were not immunized, there was no difference in the number of clinic and emergency room visits and hospitalizations between the two groups.73

• In 64 studies involving 66,000 adults, “Vaccination of healthy adults only reduced risk of influenza by 6 percent and reduced the number of missed work days by less than one day. There was change in the number of hospitalizations compared to the non-vaccinated.

• In 64 studies during 98 separate flu seasons involving elderly adults residing in nursing homes, flu vaccinations were non-significant for preventing infection.74

Richard Gale and Gary Null

Part 4,

(full pdf version of this article: http://www.garynull.com/SwineFluWhitePaper.pdf )


see alsoVaccines: A Second Opinion by Gary Null, PhD (Oct. 18, 2009)
http://educate-yourself.org/vcd/nullvaccinesecondopinion2000.shtml


Gary Null is heard daily over the internet and on many broadcast radio stations out of New York City. You can access all audio archives of the daily Gary Null Show (12 Noon-1 PM Eastern time) from this link: http://garynull.org/?feed=rss2

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