So you think you should be vaccinated? Common thought is that vaccines are protective and safe. Surprisingly, there is little to no evidence that they work or that they are safe. Flu shots for kids under 2 years old? No evidence. The elderly should get their flu shots? No studies support that at all. Get the whole family vaccinated to protect babies because a “cocooning” effect or herd immunity is a proven concept? Not so fast. Studies rely on absolute findings based on research? Nope, how about estimates and simulations used to come to a favorable conclusion about their products. Any conflicts of interest where the researchers have a financial interest in the outcome of the study? Of course. Proof is below…..

Vaccinations are a controversial subject. For every statement or opinion made on one side of the subject, informed people can easily quote another study to supposedly bolster the opposite side. Has either side truly read the details of the study? Who to believe?

Let’s look at two concepts in the vaccine world, both carrying strong opinion on both sides: cocooning, based on what is known as “herd immunity” and the effectiveness of the influenza vaccines.

Cocooning or ‘herd immunity”

The concept of cocooning is the vaccinating of parents and family members against certain infectious diseases in order to supposedly prevent transmission of these diseases to babies that are too young to get vaccinated themselves.

Herd immunity is not an immunologic idea, but rather an epidemiologic construct, which theoretically predicts successful disease control when a certain pre-calculated percentage of people in the population are immune from disease. It’s a guess. Educated, but yet a guess.

Though “deemed” by those invested in increasing vaccination rates as instrumental in rapid disease eradication, is it really? Much evidence suggests not.

And…keep in mind…the majority of people believe that vaccines actually work. There is skepticism about that as well.

The United States Public Health Service had confidently announced in 1967 its intent to swiftly eradicate measles in the USA over the winter by vaccinating a sufficient number of still susceptible children.1 Mass vaccination was implemented, but the expected herd-immunity effect did not materialize and measles epidemics did not stop in 1967.

Elementary-school children were vaccinated en mass against rubella in 1970 in Casper, Wyoming. Ironically, nine months after this local vaccination campaign, an outbreak of rubella hit Casper. The herd-immunity effect did not materialize and the outbreak involved over one thousand cases and reached several pregnant women. The perplexed authors of the study describing this outbreak wrote, “The concept that a highly immune group of pre-pubertal children will prevent the spread of rubella in the rest of the community was shown by this epidemic not always to be valid.”2

Canadian government researchers in 2011 found that to prevent one infant death from pertusis, one million parents would have to be vaccinated at a cost of $20 each3. Lead researcher, Danuta M. Skowronski of the British Columbia Center for Disease Control said, “This program appears inefficient.”

A study released in 2012 in the journal Pediatrics titled, Immunizing Parents and Other Close Family Contacts in the Pediatric Office Setting4, lead researcher Herschel Lessin, MD reveals that his report “is not directly recommending that pediatricians start offering parents shots…if you choose to do it, this is ok.” He also found it to be ineffective.

Astonishingly, he goes on to say that, “…no studies have been conducted to determine whether postpartum vaccination or vaccination of other close family contacts with influenza vaccine reduces the incidence of influenza in their children.”

Studies supporting this concept are a myth. They do not exist. Scientists, lacking data from which to work, estimate numbers and percentages and then conclude that cocooning “might” work.

Once again in the journal Pediatrics, a recent study from September 2014 titled, Parental Tdap Boosters and Infant Pertusis: A Case Control Study5 acknowledges, “…field effectiveness of vaccinating close adult contacts of newborn infants against pertusis (cocooning) is lacking. They also reference one study in Texas “…which found no reduction in infant pertusis hospitalization.”6

And…their results are based on “estimates”.

From this study, these statements about “estimates” can be found:

1. The combined effectiveness of both maternal and paternal immunization (versus neither vaccinated) was estimated from the linear combination of coefficients for the effects of maternal and paternal immunization.

2. The estimated independent protective effect of immunizing the mother alone, adjusted for the father’s status, was 48% (95% CI: –2% to 74%).

3. We also estimated the protective effect of self-reported pertussis vaccination of the mother at any time before pregnancy.

4. After adjusting for health care safety-net eligibility, educational attainment, number and age of siblings, and paternal immunization status, the estimated vaccine effectiveness was 42%.

5. We attempted to verify self-reported vaccination status of mothers in all cases and controls, but because written consent was required for us to contact providers, we were only able to obtain verification in a small subset of cases and controls… So, NO accurate information about who was or was not vaccinated prior to their enrollment in this study. Estimates.

6. This study also quotes a review of another study that claims, “…impact of pertussis vaccination of adults to prevent severe disease in young infants comes from vaccinating mothers, followed by fathers, with grandparents having a minor role. Siblings varied in importance and, given recent data regarding waning immunity in vaccinated children, need further study. But, they admit, “…We were not able to assess the source of infection among cases in this study…”.

Other interesting comments from the Parental Tdap study:

1. …we did not find any evidence of an independent protective effect among immunized fathers.

2. Most infant cases occurred in households where older siblings were fully
immunized and the study was not powered to assess under vaccination of
siblings as a separate risk factor.

This study also admits to an unfortunate limitation:

“First, because of challenges with control recruitment, the socioeconomic status of recruited control households may have been higher than for case households, as reflected in higher levels of educational attainment and lower eligibility for subsidized health care compared with census data. The degree to which we failed to completely adjust for any differences could have biased the protective effect estimate. Second, we relied on self-report for parental vaccination status, which is prone to recall bias.”

In their conclusion, the authors believe they have evidence of, “…moderate reduction in the risk of laboratory confirmed pertussis in infants aged <4 months whose parents have been booster immunized with acellular pertussis vaccine at least 4 weeks earlier.”

So, a moderate reduction in a study based on “estimates”. Uh huh.

Surprisingly, they admit to another limitation in the last paragraph of their study, “Despite being conducted in a setting where parental vaccine uptake was high and during a pertussis epidemic, we had limited power to address more specific questions such as the minimum latent period before which postnatal Tdap becomes protective and duration of protection for subsequent pregnancies. The presence and duration of any such protection is an important gap in knowledge needed to inform recommendations for programs for preventing infant pertussis.”

Gap is not a comforting scientific term.

Then there’s the conflict of interests that all researchers must reveal.

The study lists Dr. Peter B. McIntyre as the person who conceived the idea of this particular study, designed it and “critically reviewed and revised the drafts of the manuscript.”

On the last page where the “potential conflicts of interest” are reported, this paragraph tells all:

POTENTIAL CONFLICT OF INTEREST: Professor McIntyre has received in kind support from GlaxoSmithKline (GSK) in the form of vaccine supply and performance of serologic tests for a National Health and Medical Research Council–funded clinical trial of pertussis vaccine in newborns. The National Centre for Immunisation Research and Surveillance, with which Professor McIntyre, Dr Quinn, Dr Chiu, and Dr Habig are affiliated, has received in kind support in the form of pertussis toxin for assays from GSK for national pertussis seroprevalence studies conducted every 5 years.5

Dr. Quinn, Dr. Chiu, and Dr. Habig are all co-authors of the study.

GlaxoSmithKline is a manufacturer of the Tdap, Hep A, Hep B, IPV and Hib vaccines as well as the influenza vaccine, Fluarix.

The problem of conflicts of interest, funding and supplies being provided by parties who have financial interest in outcomes is common in all research. Someone has to fund the studies. Are they designed to achieve a predetermined result?

No one makes money when vaccinations aren’t taken, they only make money when they are.

So, this was a study full of estimates, limitations and conflicts of interest – used to further the implementation of a very scientifically questionable practice of cocooning.

True to form, another recent study makes conclusions based on, as they call it, simulations. Again in Pediatrics in 2013, the authors attempt to show effectiveness of pregnancy vs. postpartum vaccination, with and without cocooning. Yes, they recommend cocooning, but add in the discussion at the end of the study, “…this analysis is based on simulation data only because no clinical trials have been published.Also, this study used a “static” model to estimate epidemiologic changes…”.7

No clinical trials have been published. Interesting.

Simulation and estimates…again. No wonder there are no actual studies about this subject. There are no data anywhere that supports cocooning, in fact, to support it, you have to make data up…estimates…simulations. And yet it is rather universally accepted that not only do vaccinations work, they are safe, but that a practice called cocooning works. Sounds to me like the herd are really a bunch of lemmings jumping off the cliff together. And they all can be refuted by actually reading the study. Headlines and conclusions of the authors can many times be misleading. And those who promote vaccinations are quick to chastise those who don’t…as denying science!

A recent study from Greece agrees that maternal postpartum vaccination against influenza was associated with a significant reduction of influenza-related morbidity, healthcare seeking, and antibiotic prescription in infants during the influenza season, but unequivocally concludes, “Vaccination of other household contacts had no impact.”19

A more recent 2014 study from Pediatric Infectious Disease Journal states clearly, “Postpartum immunization and cocooning did not reduce pertussis illness in infants ≤ 6 months of age.”18

And, ask a simple question of friends and family: Do you know of any fathers, siblings or grandparents who have purposely vaccinated or updated their vaccinations in order to protect the newborn in their family? Very few…if any can be found. It’s NOT being done by any large number of people. And there are lots of wonderfully healthy children around.

If you think the above information is ridiculous, wait till you learn about the effectiveness of the influenza vaccine!

Effectiveness of Influenza Vaccine

The influenza vaccine is recommended for every healthy person over the age of 6 months. There are three basic groups to consider when reviewing this subject: infants, those over 65 and everyone else.

Despite government recommendations, there really isn’t much proof that flu vaccines are effective for infants and the elderly. In fact, the rest of us may harbor false hope as well simply because vaccines are so widely accepted as effective.

Our false belief system is fostered by several large meta-analyses (a statistical technique for combining the results of independent studies) that have suggested flu shots cut the risk of winter death in the elderly by half. That has been debunked repeatedly.

A 2005 study published in the Archives of Internal Medicine8 found influenza only causes about 5 percent of all excess winter deaths among the elderly and that it’s not possible for the shot to prevent half of all winter deaths.

In 2006, a study reported in the publication Vaccine9 found that as vaccine coverage increased among the elderly in Italy in the late 1980s, there was no corresponding drop in excess deaths.

In another 2006 paper in the International Journal of Epidemiology10, Lisa Jackson, an infectious disease epidemiologist and her colleagues showed that although vaccinated seniors were 44 percent less likely to die during flu season than unvaccinated seniors were, the vaccinated ones were also 61 percent less likely to die before flu season even started. “Naturally, you would not expect the vaccine to work before the thing it protects against is going around,” says Lone Simonsen, a research professor in global health at George Washington University and a co-author of the 2005 study in the Archives of Internal Medicine.

Is there a “healthy user” effect? This sentiment is voiced by CDC epidemiologist David Shay who agrees that people who choose to get flu shots, in other words, are already healthier and therefore the least likely to die.

In January 2012, Michael Osterholm, an epidemiologist at the University of Minnesota’s Center for Infectious Disease Research and Policy, and his colleagues published a meta-analysis in The Lancet Infectious Diseases that analyzed the results of all randomized controlled clinical trials conducted between 1967 and 2011 on the effects of flu shots. It found that there have been no clinical trials evaluating the effects of the traditional flu vaccine in the elderly.11

Why is that? It’s because the U.S government prohibits scientists from testing in a randomized controlled trial, a treatment the medical community already considers to be effective. Doing that would involve denying treatment to half of the participants, potentially putting them at risk.

And what about the kids under two years of age?

The U.S. Advisory Committee on Immunization Practices began recommending flu vaccination for all healthy children older than six months in 2010. It was claimed this was “supported by evidence that annual influenza vaccination is a safe and effective preventive health action with potential benefit in all age groups.”

Yet a July 2012 Cochrane Collaboration systematic review12 concluded that for kids under the age of two, the current vaccines”are not significantly more efficacious than placebo.”

In fact, the authors also note that, “It was surprising to find only one study of inactivated vaccine in children under two years, given current recommendations to vaccinate healthy children from six months of age in the USA, Canada, parts of Europe and Australia.”

Only one study?

In their conclusion, the authors reveal the conflicts of interest they found: “This review includes trials funded by industry. An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry-funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. Studies funded from public sources were significantly less likely to report conclusions favourable to the vaccines. The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in the light of this finding.”

Again, more conflicts of interest. Let’s look a little deeper into this subject.

Conflicts of Interest

In 2008, CBS News investigative correspondent Sharyl Attkisson reported on the “interesting” financial ties between the Academy of Pediatrics and vaccine manufacturers. This academy publishes the journal, Pediatrics, referenced numerous times above.

Attkisson writes, “The vaccine industry gives millions to the Academy of Pediatrics for conferences, grants, medical education classes and even helped build their headquarters. The totals are kept secret, but public documents reveal bits and pieces.”

She lists these three points from many others that could have been listed:

• A $342,000 payment from Wyeth, maker of the pneumococcal vaccine – which makes $2 billion a year in sales.
• A $433,000 contribution from Merck, the same year the academy endorsed Merck’s HPV vaccine – which made $1.5 billion a year in sales.
• Another top donor: Sanofi Aventis, maker of 17 vaccines and a new five-in-one combo shot just added to the childhood vaccine schedule last month.

She specifically mentions pediatrician Dr. Paul Offit, perhaps the most widely quoted defender of vaccine safety. Attkisson reports, “Offit holds a $1.5 million dollar research chair at Children’s Hospital, funded by Merck. He holds the patent on an anti-diarrhea vaccine he developed with Merck, Rotateq, which has prevented thousands of hospitalizations. And future royalties for the vaccine were just sold for $182 million cash. Dr. Offit’s share of vaccine profits? Unknown.”

Conclusions

So, what takeaways might we derive from this information? How about these:

1. Vaccines don’t work like we think they do. We presume they work.
2. Cocooning is a theory and there are no studies that support it as science.
3. Estimates are routinely used to support a desired outcome.
4. Conflicts of interest are also common. Ignored by the industry and unknown by the average person or those who don’t investigate each individual study.
5. There are NO studies that support protective effects of the influenza vaccine in infants between six months and two years or for those over 65. None.
6. The conflicts of interest in the influenza studies seem to outpace other areas of study.
7. So what are we to think? They have gotten it wrong in the above information, but they have it right with regard to all other vaccinations being effective and safe?

Recently in the news:

1. The CDC…in October 2014…with regard to the Ebola crisis: very few are accepting their explanations about Ebola or how to handle it. They appear stunningly incompetent. But they are competent about vaccinations?
2. The CDC is the same organization that approves a $500K study on if chimpanzees are right or left handed.14 Doesn’t increase our confidence, does it?
3. A whistle-blower who used to work for the CDC recently admitted to scientific fraud at the CDC. Data was omitted showing the MMR vaccine given to African American males before the age of 36 months, increased the risk of autism. And there’s more. Two federal court cases are now pending.15

Let’s look at this a bit more closely. Bored yet?

Then There’s Those Pesky Whistle-blowers

Merck, the manufacturer of MMR, Hib, Hep B, Hep A, pneumonococcal, zoster and varicella vaccines, is facing lawsuits over its Measles-Mumps-Rubella (MMR) vaccine following numerous allegations from two former Merck scientists turned whistle-blowers. Another whistle-blower, a scientist at the Centers for Disease Control, has confessed of misconduct involving the same MMR vaccine.

Merck will be defending itself and its vaccine in at least two federal court cases after a U.S. District judge earlier this month (September 2014) threw out Merck’s attempts at dismissal.

The first court case, United States v. Merck & Co.16, are claims by two former Merck scientists that Merck “fraudulently misled the government and omitted, concealed, and adulterated material information regarding the efficacy of its mumps vaccine in violation of the FCA [False Claims Act].”

These fraudulent activities were designed to produce test results that would meet the FDA’s requirement the mumps vaccine be 95% effective.

The whistle-blowers charge Merck’s misconduct as: It “failed to disclose that its mumps vaccine was not as effective as Merck represented, (ii) used improper testing techniques, (iii) manipulated testing methodology, (iv) abandoned undesirable test results, (v) falsified test data, (vi) failed to adequately investigate and report the diminished efficacy of its mumps vaccine, (vii) falsely verified that each manufacturing lot of mumps vaccine would be as effective as identified in the labeling, (viii) falsely certified the accuracy of applications filed with the FDA, (ix) falsely certified compliance with the terms of the CDC purchase contract, (x) engaged in the fraud and concealment describe herein for the purpose of illegally monopolizing the U.S. market for mumps vaccine, (xi) mislabeled, misbranded, and falsely certified its mumps vaccine, and (xii) engaged in the other acts described herein to conceal the diminished efficacy of the vaccine the government was purchasing.”

Failed, improper, manipulated, abandoned, falsified, falsely, fraud and concealment, mislabeled, mis-branded. At least they didn’t say estimates and simulations.

The third whistleblower, senior CDC scientist named William Thompson indirectly blew the whistle on Merck. He threw himself under the bus and colleagues at the CDC who participated in a 2004 study involving the MMR vaccine. These allegations involve a cover-up of data pointing to high rates of autism in African-American boys after they were vaccinated with MMR.

How Many People Die from Influenza Each Year

There’s another interesting emotional argument that takes place every time people debate the influenza vaccine. Those in favor of vaccines always quote around 20-50,000 people dying each year from influenza. Hence, the need for the “protective” vaccinations.

Hardly. All one needs to do is a bit of research…

According to the CDC’s own statistics from the year 201117, there were 52,826 deaths from influenza AND pneumonia. The CDC combines both health issues into one category reporting 1,532 of the deaths were from influenza and 51,294 were from pneumonia.

The probable reason for combining these deaths is the reality that many…not all…people who contract the flu may develop pneumonia as a secondary infection. Some then die from pneumonia.

Of those who do die from pneumonia, did they all have the flu first? There is no data with that information. But, there are 30 times more deaths from pneumonia than for the flu each year. Again, the “healthy effect” may suggest the most frail get pneumonia and die from it and obviously not the flu.

If the secondary infection is what is killing that many people…since we DO have a pneumonia vaccine…why do they push the influenza vaccine and not the pneumococcal vaccine?

Wyeth and Merck produce the pneumococcal vaccines and GlaxoSmithKline, Sanofi Pasteur and Novartis, the influenza vaccines. Think influence and lobbying of the CDC. Just guessing, but one probably does it far more successfully than the other. Perhaps one is far more profitable than the other.

Debates about this subject usually take a common course. The above information is presented and those who blindly favor vaccination as science…though very little exists…will argue using two techniques:

1. Quote more flawed studies, not truly read thoroughly, as if they are additional evidence of the effectiveness and safety of vaccines.
2. Attack people individually as if doing so negates their perspective. This deflects from having to have any actual facts to prove your side.

So, who is denying science in this debate?

One thing is certain, where there’s smoke, there’s fire.

1) Sencer DJ, Dull HB, Langmuir AD, “Epidemiologic basis for eradication of measles in 1967,” Public Health Rep 82, 253-256 (1967).
2) Klock LE, Rachelefsky GS, “Failure of rubella herd immunity during an epidemic,” N Engl J Med 288, 69-72 (1973).
3) Danuta M. Skowronski, et al. The Number Needed to Vaccinate to Prevent Infant Pertussis Hospitalization and Death Through Parent Cocoon Immunization. Clinical Infectious Diseases, 2011
4) Herschel R. Lessin, MD et al. Immunizing Parents and Other Close Family Contacts in the Pediatric Office Setting, Pediatrics, January 1, 2012: 129(1); e247-e253.
5) Helen E. Quinn, et al. Parental Tdap Boosters and Infant Pertusis: A Case Control Study, Pediatrics September 15, 2014: 134:713-720.
6) Castagnini LA, Healy CM, et al. Impact of maternal postpartum tetanus and diphtheria toxoids and acellular pertussis immunization on infant pertussis infection. Clin Infect Dis. 2012;54(1):78–84.
7) Andrew Terranella, Garrett R. Beeler Asay, et al. Pregnancy Dose Tdap and Postpartum Cocooning to Prevent Infant Pertussis: A Decision Analysis. Pediatrics 2013;131: e1748–e1756.
8) Lone Simonsen, PhD; Thomas A. Reichert, MD, PhD, et al.
Impact of Influenza Vaccination on Seasonal Mortality in the US Elderly Population, Arch Intern Med. 2005;165(3):265-272.
9) Rizzo C, Viboud C, et al. Influenza-related mortality in the Italian elderly: no decline associated with increasing vaccination coverage. Vaccine. 2006 Oct 30;24(42-43):6468-75.
10) Lisa A. Jackson, et al. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int. J. Epidemiol. (April 2006) 35 (2): 337-344.
11) Michael T Osterholm, PhD, et al. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis.The Lancet Infectious Diseases, Volume 12, Issue 1, Pages 36 – 44, January 2012.
12) Jefferson T, Rivetti A, et al. Vaccines for preventing influenza in healthy children. Cochrane Database of Systematic Reviews 2012, Issue 8. Art. No.: CD004879.
13) http://www.cbsnews.com/news/how-independent-are-vaccine-defenders/
14) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2043156/
15) http://www.huffingtonpost.ca/lawrence-solomon/merck-whistleblowers_b_5881914.html
16) probeinternational.org/library/wp-content/uploads/2014/09/chatom-v-merck.pdf
17) http://www.cdc.gov/nchs/fastats/deaths.htm
18) Healy CM, et al. Evaluation of the Impact of a Pertussis Cocooning Program on Infant Pertussis Infection. Pediatr Infect Dis J. 2014 Jul 3.
19) Helena C. Maltezou, et al. Impact of Postpartum Influenza Vaccination of Mothers and Household Contacts in Preventing Febrile Episodes, Influenza-like Illness, Healthcare Seeking, and Administration of Antibiotics in Young Infants During the 2012–2013 Influenza Season Clin Infect Dis. (2013) 57 (11): 1520-1526.