Merck’s Former Doctor Predicts Gardasil To Become The Greatest Medical Scandal Of All Time

dr-bernard-dalbergue

Several vaccines are linked to dramatically increased infant mortality. Why? Because they are nothing but toxic concoctions

Sayer Ji
GreenMedInfo
Thu, 19 Dec 2013 17:29 CST

A new study published in the journal Vaccine has brought to light an extremely disturbing though still virtually unreported dark side to immunization campaigns within low-income countries, namely, the observation that infant mortality sometimes increases when the number of co-administered vaccines increases; a finding diametrically opposed to the widely held belief that vaccination is always a life-saving intervention, and that the more vaccines administered to infants the better.

New Study Links DTP and Yellow Fever Vaccines To Infant Deaths

The new observational study from the West African country Guinea-Bissau titled, “Co-administration of live measles and yellow fever vaccines and inactivated pentavalent vaccines is associated with increased mortality compared with measles and yellow fever vaccines only,”[i] opens with a reference to the already consistent observation in the biomedical literature that the co-administration of inactivated diphtheria-tetanus-pertussis (DTP) vaccine and live attenuated measles vaccine (MV) increases mortality compared with receiving MV only. [ii] [iii]

The purpose of the new investigation was to determine whether co-administration of pentavalent vaccine (PV) with MV and yellow fever vaccine (YF) had similar negative effects. Both PV and YF vaccines were introduced in Guinea-Bissau in 2008, with PV containing 5 vaccine antigens in one shot (DTP-H. Influenza type B-Hepatitis B).

The study findings emerged from a randomized, placebo-controlled clinical trial conducted in 2007-2011, where researchers administered vitamin A at routine vaccination contacts among children aged 6-23 months in urban and rural Guinea-Bissau. A total of 2331 children were randomized to placebo, receiving either live vaccines only (MV or MV+YF) or a combination of live and inactivated vaccines (MV+DTP or MV+YF+pentavalent).

When mortality was compared, the adjusted mortality rate ratio (MRR) for co-administered live and inactivated vaccines compared with live vaccines only was over three times greater (3.24 (1.20-8.73). When MV+YF+pentavalent was compared with MV+YF only, the adjusted MRR was almost eight times greater (7.73 (1.79-33.4)) for the combination of the three vaccines versus two.

The researchers concluded:

“In line with previous studies of DTP, the present results indicate that pentavalent vaccine co-administered with MV and YF is associated with increased mortality.”

Pentavalent and Yellow Fever Vaccines Already Linked To Fatalities

This finding takes on a more disturbing light when one considers that by the end of 2013, largely through the efforts of the Global Alliance for Vaccines and Immunisation (GAVI), pentavalent vaccines will have reached close to 200 million children in 72 developing countries. GAVI also states that yellow fever vaccines have been administered to 60 million children, “averting an estimated 160,000 future deaths.” Pentavalent vaccines have already created widespread controversy by being linked to clusters of infant deaths in every Southeast and South Asian country where they have been introduced, including Bhutan, Sri LankaVietnam and India. Similarly, yellow fever vaccines have been linked to deaths as far back as 2001, when 7 people were found contracting yellow fever and dying from the vaccine itself. The obvious question then emerges: Could both the pentavalent and yellow fever vaccines actually be increasing mortality despite GAVI’s position that they are a life-saving intervention that presumably should be administered to every at risk child in the developing world?

What adds additional weight to this concern is that there is already a well-established history of DTP (and oral polio) vaccines being linked to increased morbidity and mortality in low-income countries, starting with this 2000 BMJ article also in a population of vaccinated infants from Guinea-Bissau that found recipients of one dose of DTP or polio vaccines had higher mortality than children who had received none of these vaccines. A 2011 study of Guinea-Bissau females found DTP vaccine administered simultaneously with measles vaccine is associated with increased morbidity and poor growth in girls.[iv] Clearly the vaccines can cause significant harm. Another far more recent study published this year in the journal Tropical Medicine and International Health found that DTP vaccination is responsible for higher mortality among Indian girls. Another 2005 study on vaccinated female infants in India found that those who receive both the tuberculosis vaccine Bacillus Calmette – Guérin (BCG) and DTP experience significantly higher mortality than those who receive only one of the two vaccines.[v]

Given the multitude of studies showing vaccine-induced harm, including increased infant mortality, especially for DTP vaccines, one wonders how global vaccination campaigns can blatantly promote them as infallibly effective and extremely safe.

Evidence That Vaccines Are Toxic Exposures

It has been hypothesized that this association with DTP vaccines and increased mortality may be due to the Th2-polarising effect of the aluminum phosphate adjuvant in the vaccine, as well as the chronic inflammation caused by the intramuscular administration of the vaccine at the site of injection, [vi] but another obvious explanation is that the vaccines themselves are toxic exposures, with the more vaccines given to infants the higher the likelihood of synergistic toxicity and resultant morbidity and mortality.

Exactly this possibility was raised by a 2011 study published in the journal Human and Experimental Toxicology titled, “Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity?”,[vii] which brought to the fore the fact that, “The infant mortality rate (IMR) is one of the most important indicators of the socio-economic well-being and public health conditions of a country. The US childhood immunization schedule specifies 26 vaccine doses for infants aged less than 1 year-the most in the world-yet 33 nations have lower IMRs.” The study found that there is a highly statistically significant correlation between increasing number of vaccine doses and increasing infant mortality rates.

With the ongoing expansion of immunization schedules in the U.S. and globally, justified by the idea that more vaccines, and more vaccine antigens combined within each injection, will confer greater overall benefit to health (that far outweigh the risks of the vaccines themselves), and by ‘vaccine safety’ spokespersons such as Paul Offit claiming as many as 10,000 vaccines can be administered to a child at once safely, this new study indicates quite the opposite is true.

References

[i] Ane Bærent Fisker, Henrik Ravn, Amabelia Rodrigues, Marie Drivsholm Ostergaard, Carlito Bale, Christine Stabell Benn, Peter Aaby. Co-administration of live measles and yellow fever vaccines and inactivated pentavalent vaccines is associated with increased mortality compared with measles and yellow fever vaccines only. An observational study from Guinea-Bissau. Vaccine. 2013 Dec 7. pii: S0264-410X(13)01663-0. doi: 10.1016/j.vaccine.2013.11.074.

[ii] J Agergaard, E Nante, G Poulstrup, J Nielsen, K L Flanagan, L Østergaard, C S Benn, P Aaby.Diphtheria-tetanus-pertussis vaccine administered simultaneously with measles vaccine is associated with increased morbidity and poor growth in girls. A randomised trial from Guinea-Bissau. Vaccine. 2011 Jan 10;29(3):487-500. Epub 2010 Nov 18. PMID:21093496

[iii] Peter Aaby, Sidu Biai, Jens Erik Veirum, Morten Sodemann, Ida Lisse, May-Lill Garly, Henrik Ravn, Christine Stabell Benn, Amabelia Rodrigues. DTP with or after measles vaccination is associated with increased in-hospital mortality in Guinea-Bissau. Vaccine. 2007 Jan 26;25(7):1265-9. Epub 2006 Oct 18.

[iv] J Agergaard, E Nante, G Poulstrup, J Nielsen, K L Flanagan, L Østergaard, C S Benn, P Aaby. Diphtheria-tetanus-pertussis vaccine administered simultaneously with measles vaccine is associated with increased morbidity and poor growth in girls. A randomised trial from Guinea-Bissau. Vaccine. 2011 Jan 10;29(3):487-500. Epub 2010 Nov 18. PMID:21093496

[v] Lawrence H Moulton, Lakshmi Rahmathullah, Neal A Halsey, R D Thulasiraj, Joanne Katz, James M Tielsch. Evaluation of non-specific effects of infant immunizations on early infant mortality in a southern Indian population. Trop Med IntHealth. 2005 Oct;10(10):947-55. PMID: 16185228

[vi] Mogens Helweg Claesson. Immunological Links to Nonspecific Effects of DTwP and BCG Vaccines on Infant Mortality. J Trop Med. 2011 ;2011:706304. Epub 2011 May 5. PMID: 21760811

[vii] Neil Z Miller, Gary S Goldman. Infant mortality rates regressed against number of vaccine doses routinely given: Is there a biochemical or synergistic toxicity? Hum Exp Toxicol. 2011 May 4. Epub 2011 May 4. PMID: 21543527

Should we hold those vaccinated against pertussis legally liable for whooping cough outbreaks?

whooping cough boy

Toni Bark, MD
Green Med Info
Tue, 03 Dec 2013 01:00 CST

The recent news articles to hit the mainstream media in the past week finally states what public health officials and epidemiologists have known for some time: those vaccinated against pertussis are carrying and spreading the bacteria and are responsible for most of the outbreaks.

This news raises the question:

Should we hold those vaccinated with the pertussis vaccine, legally liable for outbreaks?

And, if you look up scholarly articles about previous outbreaks of measles, you’ll find academic papers on an entity termed “the paradox of measles“; a paradox because those vaccinated are the ones contracting the disease whilst the unvaccinated in many communities with outbreaks, are unscathed.

In addition, the rise in shingles over the past decade or so, is due to the chicken pox vaccine. This link is not denied in academic literature and was even predicted by mathematical biologists and epidemiologists, and was confirmed by another study funded by the CDC.

If vaccinated children and adults are capable of spreading disease, shall we hold them and their parents legally liable for outbreaks? Shall we mandate ‘unvaccination’ as a requirement for public school? Since we can’t ‘unvaccinate,’ shall vaccinated children be kicked out of public school?

While the above statements seem absurd, they are equivalent arguments bioethicist, Art Caplan has and continues to make.

Caplan believes parents of unvaccinated children should be held legally liable for outbreaks of disease.

Mind you, Caplan is no regular academic bioethicist, he is a bioethicist who has made a good deal of money for writing pro-industry speak.

If you read about Art Caplan and his direct financial conflicts of interest, you’ll also read Art believes these financial conflicts can be managed while producing unbiased work. He and his previous institution of employment, the University of Pennsylvania Department of Bioethics received mega fees from major pharmaceutical companies and the department of vaccine bioethics at U Penn was massively funded by the big vaccine producers.

In addition to the DTap rendering recipients colonized with pertussis bacteria, consider the following;

a) Recently vaccinated children must be kept away from cancer patients lest they shed vaccine virus.

b) The oral polio vaccine was the cause of all polio cases in the US for several decades until, finally, the vaccine industry had a vaccine to replace it with.

c) The nasal flu vaccine renders the recipient shedding viruses for several days.

d) The rotavirus vaccine is shed in the recipient’s stool causing diarrhea in other children.

The above examples are just a few of how the recently vaccinated can shed pathogens and hence spread diseases.

So while the mainstream media is waking up to the realities of vaccination and outbreaks, shall we turn on all those who chose to vaccinate and make them pariahs?

I think the freedom to choose the risks vs benefits of vaccinating should be left to the consumer and not dictated by those with conflicts of interest.

Toni Bark, M.D. (LEED AP) graduated from Rush Medical College in Chicago, Illinois in 1986. Dr. Bark has been medical director for various departments and hospitals and has extensive post residency training in aesthetic medicine, nutritional medicine, and classical homeopathy with the top trainers in the various fields. Learn more about her work on her websitehttp://www.disease-reversal.com.

Influenza: marketing vaccine by marketing disease

Harvard Researcher Condemns Flu Vaccine
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3037 (Published 16 May 2013)
Cite this as: BMJ 2013;346:f3037
 

Peter Doshi, postdoctoral fellow

The CDC pledges “To base all public health decisions on the highest quality scientific data, openly and objectively derived.” But Peter Doshi argues that in the case of influenza vaccinations and their marketing, this is not so

Promotion of influenza vaccines is one of the most visible and aggressive public health policies today. Twenty years ago, in 1990, 32 million doses of influenza vaccine were available in the United States. Today around 135 million doses of influenza vaccine annually enter the US market, with vaccinations administered in drug stores, supermarkets—even some drive-throughs. This enormous growth has not been fueled by popular demand but instead by a public health campaign that delivers a straightforward, who-in-their-right-mind-could-possibly-disagree message: influenza is a serious disease, we are all at risk of complications from influenza, the flu shot is virtually risk free, and vaccination saves lives. Through this lens, the lack of influenza vaccine availability for all 315 million US citizens seems to border on the unethical. Yet across the country, mandatory influenza vaccination policies have cropped up, particularly in healthcare facilities,1 precisely because not everyone wants the vaccination, and compulsion appears the only way to achieve high vaccination rates.2 Closer examination of influenza vaccine policies shows that although proponents employ the rhetoric of science, the studies underlying the policy are often of low quality, and do not substantiate officials’ claims. The vaccine might be less beneficial and less safe than has been claimed, and the threat of influenza appears overstated.

Now we are all “at risk” of serious complications

Influenza vaccine production has grown parallel to increases in the perceived need for the vaccine. In the US, the first recommendations for annual influenza vaccination were made in 1960 (table1). Through the 1990s, the key objective of this policy was to reduce excess mortality. Because most of influenza deaths occurred in the older population, vaccines were directed at this age group. But since 2000, the concept of who is “at risk” has rapidly expanded, incrementally encompassing greater swathes of the general population (box 1). As one US Centers for Disease Control and Prevention (CDC) poster picturing a young couple warns: “Even healthy people can get the flu, and it can be serious.”3 Today, national guidelines call for everyone 6 months of age and older to get vaccinated. Now we are all “at risk.”

 
 
 
 

Table 1. Expansion of influenza vaccination recommendations, 1960 to present

 
Population 1960 1984 1987 2000 2004 2006 2008 2009 2010
Recommendations by age                  
Adults ≥ 65 years X X X X X X X X X
Adults ≥ 50 years       X X X X X X
Children 6 to 23 months         X X X X X
Children 6 to 59 months           X X X X
Children 6 months to 18 years, if feasible             X X X
Children 6 months to 18 years               X X
Everyone ≥ 6 months                 X
Recommendations by condition or occupation                  
Pregnant women (2nd and 3rd trimester)       X X X X X X
Pregnant women (all trimesters)         X X X X X
Healthcare workers   X X X X X X X X
Household contacts of high risk groups     X X X X X X X
Household contacts and out of home
caregivers of children 0-23 months
        X X X X X
Household contacts and out of home
caregivers of children 0-59 months
          X X X X

Sources: Advisory Committee on Immunization Practices,5, 44-48 Osterholm,49 and Layton et al.50

 
 

Box 1. A policy without an objective

Despite the enormous sums of money spent fighting the perceived threat of influenza, there are surprisingly few instances of unambiguous statements describing the objectives of influenza vaccination policy. Here is a sampling, drawn from more than five decades of influenza vaccination policies in the United States, that demonstrates the changing purpose of the campaign—from one with a clear objective of saving older people’s lives, to one without any stated objective.

In 1964, four years after annual influenza vaccination policies were first instituted, CDC influenza branch chief Alexander Langmuir and colleagues wrote that the recommendation “was based on three broad assumptions: 1. That excess mortality was the most important consequence of epidemic influenza. 2. That polyvalent virus vaccines had been at least partially effective in preventing clinical illness during most epidemics and therefore presumably would reduce the risk of death among the aged and chronically ill. 3. That epidemics cannot be predicted with sufficient accuracy to permit confident planning of control measures on a year to year basis.”4 In 1984, recommendations from the Advisory Committee on Immunization Practices stated: “Because of the increasing proportion of elderly persons in the United States and because age and its associated chronic diseases are risk factors for severe influenza illness, the future toll from influenza may increase, unless control measures are used more vigorously than in the past. . . . For about 20 years, efforts to reduce the impact of influenza in the United States have been aimed primarily at immunoprophylaxis [vaccination] of persons at greatest risk of serious illness or death.”5 Today, the recommendations do not even mention the effect the policy aims to achieve.6

Box 2: Deciphering the numbers

As concern surged this January over a worse than usual influenza season, members of the media seemed unsure whether the CDC’s announcement that “vaccine effectiveness (VE) was 62%”7 represented good versus disappointing news.8

NBC anchor Brian Williams: “I worry about this number. I woke up to reports of this number. It can disincentivize people to go get that flu shot which all of you are saying is still so important.”

Chief medical editor Nancy Snyderman: “And I had the same concern when you see 62%, because I’m afraid people will say ‘well, it’s half and half.’ But remember, if you have a 62% less chance of getting of getting the flu, it means less chance of being on antibiotics, less chance of ending up in an intensive care unit, and as we’ve seen from this uptick in numbers, 62% less chance of dying.”9

Although the study never tested more severe outcomes such as hospitalizations and death, the logic is nonetheless tempting: if 62% fewer people get influenza, then would not one expect 62% fewer of all of influenza’s complications? Not necessarily so. The reason is that the 62% reduction statistic almost certainly does not hold true for all subpopulations. In fact, there are good reasons to assume it does not. It is well known that influenza infections are more severe for certain groups of people, such as the frail older population, compared with others like healthy young adults. The CDC study did not present the statistics by age or health status, but an update of the study released one month later showed 90% of participants were younger than 65 years, and for older people, there was no significant benefit (vaccine effectiveness was 27%; 95% confidence interval, 31% to 59%).10

Not to worry: officials say influenza vaccines save lives

Risk of serious illness is a problem—but, according to the official narrative, a tractable problem, thanks to vaccines. As another CDC poster, this time aimed at seniors, explains: “Shots aren’t just for kids. Vaccines for adults can prevent serious diseases and even death.”11 And in its more technical guidance document, CDC musters the evidence to support its case. The agency points to two retrospective, observational studies. One, a 1995 peer-reviewed meta-analysis published in Annals of Internal Medicine, concluded: “many studies confirm that influenza vaccine reduces the risks for pneumonia, hospitalization, and death in elderly persons during an influenza epidemic if the vaccine strain is identical or similar to the epidemic strain.”12 They calculated a reduction of “27% to 30% for preventing deaths from all causes”—that is, a 30% lower risk of dying from any cause, not just from influenza. CDC also cites a more recent study published in the New England Journal of Medicine, funded by the National Vaccine Program Office and the CDC, which found an even larger relative reduction in risk of death: 48%.13

If true, these statistics indicate that influenza vaccines can save more lives than any other single licensed medicine on the planet. Perhaps there is a reason CDC does not shout this from the rooftop: it’s too good to be true. Since at least 2005, non-CDC researchers have pointed out the seeming impossibility that influenza vaccines could be preventing 50% of all deaths from all causes when influenza is estimated to only cause around 5% of all wintertime deaths.14 15

So how could these studies—both published in high impact, peer reviewed journals and carried out by academic and government researchers with non-commercial funding—get it wrong? Consider one study the CDC does not cite, which found influenza vaccination associated with a 51% reduced odds of death in patients hospitalized with pneumonia (28 of 352 [8%] vaccinated subjects died versus 53 deaths among 352 [15%] unvaccinated control subjects).16 Although the results are similar to those of the studies CDC does cite, an unusual aspect of this study was that it focused on patients outside of the influenza season—when it is hard to imagine the vaccine could bring any benefit. And the authors, academics from Alberta, Canada, knew this: the purpose of the study was to demonstrate that the fantastic benefit they expected to and did find—and that others have found, such as the two studies that CDC cites—is simply implausible, and likely the product of the “healthy-user effect” (in this case, a propensity for healthier people to be more likely to get vaccinated than less healthy people). Others have gone on to demonstrate this bias to be present in other influenza vaccine studies.17 18 Healthy user bias threatens to render the observational studies, on which officials’ scientific case rests, not credible.

Yet for most people, and possibly most doctors, officials need only claim that vaccines save lives, and it is assumed there must be solid research behind it. But for those that bother to read the CDC’s national guidelines19—a 68 page document of 33 360 words and 552 references—one finds that the evidence cited is these observational studies that the agency itself acknowledges may be undermined by bias. The guidelines state:

“. . . studies demonstrating large reductions in hospitalizations and deaths among the vaccinated elderly have been conducted using medical record databases and have not measured reductions in laboratory-confirmed influenza illness. These studies have been challenged because of concerns that they have not controlled adequately for differences in the propensity for healthier persons to be more likely than less healthy persons to receive vaccination.”19

CDC does not rebut or in any other way respond to these criticisms. It simply acknowledges them, and leaves it at that.

If the observational studies cannot be trusted, what evidence is there that influenza vaccines reduce deaths of older people—the reason the policy was originally created? Virtually none. Theoretically, a randomized trial might shine some light—or even settle the matter. But there has only been one randomized trial of influenza vaccines in older people—conducted two decades ago—and it showed no mortality benefit (the trial was not powered to detect decreases in mortality or any complications of influenza). This means that influenza vaccines are approved for use in older people despite any clinical trials demonstrating a reduction in serious outcomes. Approval is instead tied to a demonstrated ability of the vaccine to induce antibody production, without any evidence that those antibodies translate into reductions in illness.

Perhaps most perplexing is officials’ lack of interest in the absence of good quality evidence. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, told the Atlantic that it “would be unethical” to do a placebo controlled study of influenza vaccine in older people.20 The reason? Placebo recipients would be deprived of influenza vaccines—that is, the standard of care, thanks to CDC guidelines.

This is not to say influenza vaccines have no proven benefit. Many randomized controlled trials of influenza vaccines have been conducted in the healthy adult population, and a systematic review found that, depending on vaccine-virus strain match, vaccinating between 33 and 100 people resulted in one less case of influenza.21 No evidence exists, however, to show that this reduction in risk of symptomatic influenza for a specific population—here, among healthy adults—extrapolates into any reduced risk of serious complications from influenza such as hospitalizations or death in another population (complications largely occur among the frail, older population). This fact seems hard for many health commentators to grasp, who seem all too ready to take the largest statistic and apply it to all outcomes for all populations. At a press briefing this winter, CDC director Thomas Frieden said a preliminary CDC study had found “the overall vaccine effectiveness to be 62%,” He explained that this estimate of relative risk reduction: “means that if you got vaccinated you’re about 60% less likely to get the flu that requires you to go to your doctor.” On the evening news, the CDC’s message was translated into a claim that influenza vaccines will cut the risk of death by 62%, despite the fact that the CDC study did not even measure mortality (box 2). Reflecting on the same CDC study, two authors editorialized in the Journal of the American Medical Association that there exists an irrational pessimism about influenza vaccine: “A prevention measure that reduced the risk of a serious outcome by 60% in most instances would be a noted achievement; yet for influenza vaccine, it is seen as a ‘failure.’” Here, too, the authors appear unaware that the CDC study they cite did not measure any “serious outcome” like pneumonia, only medically attended acute respiratory illness with influenza confirmed by the laboratory.

Officials say influenza vaccines are safe

The CDC’s universal influenza vaccination recommendation carries the implicit message that, beyond those for whom the vaccine is contraindicated, influenza vaccine can only do good; there is no need to weigh risks against benefits. In October 2009, the US National Institutes of Health produced a promotional YouTube video featuring Fauci. Urging US citizens to get vaccinated against the H1N1 influenza, Fauci stressed the vaccine’s safety: “the track record for serious adverse events is very good. It’s very, very, very rare that you ever see anything that’s associated with the vaccine that’s a serious event.”

Months later, Australia suspended its influenza vaccination program in under five year olds after many (one in every 110 vaccinated) children had febrile convulsions after vaccination. Another serious reaction to influenza vaccines—and also unexpected—occurred in Sweden and Finland, where H1N1 influenza vaccines were associated with a spike in cases of narcolepsy among adolescents (about one in every 55 000 vaccinated). Subsequent investigations by governmental and non-governmental researchers confirmed the vaccine’s role in these serious events.22 23 24 25

Selling sickness: what’s in a name?

Drug companies have long known that to sell some products, you would have to first sell people on the disease. Early 20th century advertising for the mouthwash Listerine, for example, warned readers of the problem of “halitosis”—thereby turning bad breath into a widespread social concern.26 Similarly, in the 1950s and 1960s, Merck launched an extensive campaign to lower the diagnostic threshold for hypertension, and in doing so enlarging the market for its diuretic drug, Diuril (chlorothiazide).27 Today drug companies suggest that we have underdiagnosed epidemics of erectile dysfunction, social anxiety disorder, and female sexual dysfunction, each with their own convenient acronym and an approved medication at the ready. Could influenza—a disease known for centuries, well defined in terms of its etiology, diagnosis, and prognosis—be yet one more case of disease mongering? I think it is. But unlike most stories of selling sickness, here the salesmen are public health officials, worried little about which brand of vaccine you get so long as they can convince you to take influenza seriously.

Marketing influenza vaccines thus involves marketing influenza as a threat of great proportions. The CDC’s website explains that “Flu seasons are unpredictable and can be severe,” citing a death toll of “3000 to a high of about 49 000 people.” However, a far less volatile and more reassuring picture of influenza seems likely if one considers that recorded deaths from influenza declined sharply over the middle of the 20th century, at least in the United States, all before the great expansion of vaccination campaigns in the 2000s, and despite three so-called “pandemics” (1957, 1968, 2009) (fig 1).

Fig 1 Crude mortality per 100 000 population, by influenza season (July to June of the following year), for seasons 1930-31 to 2009-10, US. Data sources: Doshi P. Am J Pub Health 2008;98:939-45.

 

But perhaps the cleverest aspect of the influenza marketing strategy surrounds the claim that “flu” and “influenza” are the same. The distinction seems subtle, and purely semantic. But general lack of awareness of the difference might be the primary reason few people realize that even the ideal influenza vaccine, matched perfectly to circulating strains of wild influenza and capable of stopping all influenza viruses, can only deal with a small part of the “flu” problem because most “flu” appears to have nothing to do with influenza. Every year, hundreds of thousands of respiratory specimens are tested across the US. Of those tested, on average 16% are found to be influenza positive. (fig 2).

All influenza is “flu,” but only one in six “flus” might be influenza. It’s no wonder so many people feel that “flu shots” don’t work: for most flus, they can’t.

But perhaps the cleverest aspect of the influenza marketing strategy surrounds the claim that “flu” and “influenza” are the same. The distinction seems subtle, and purely semantic. But general lack of awareness of the difference might be the primary reason few people realize that even the ideal influenza vaccine, matched perfectly to circulating strains of wild influenza and capable of stopping all influenza viruses, can only deal with a small part of the “flu” problem because most “flu” appears to have nothing to do with influenza. Every year, hundreds of thousands of respiratory specimens are tested across the US. Of those tested, on average 16% are found to be influenza positive. (fig 2).

 

 
 
 

Fig 2 Proportion of specimens testing positive for influenza at World Health Organization (WHO) Collaborating Laboratories and National Respiratory and Enteric Virus Surveillance System (NREVSS) laboratories through the United States. Data are compiled and published by CDC.28-43

 

Notes

Cite this as: BMJ 2013;346:f3037

Footnotes

  • Acknowledgements: I am grateful to Yuko Hara, Tom Jefferson, and Edward Davies, for their comments.

  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and declare the following interests: PD is a co-recipient of a UK National Institute for Health Research grant to carry out a Cochrane review of neuraminidase inhibitors (http://www.hta.ac.uk/2352). PD received €1500 from the European Respiratory Society in support of his travel to the society’s September 2012 annual congress where he gave an invited talk on oseltamivir. He is funded by an institutional training grant from the Agency for Healthcare Research and Quality (AHRQ) #T32HS019488. AHRQ had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

  • Provenance and peer review: commissioned: not externally peer reviewed

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Vaccines for Children Program: Vulnerabilities in Vaccine Management

http://oig.hhs.gov/

Vaccines for Children Program: Vulnerabilities in Vaccine Management

Summary

WHY WE DID THIS STUDY

CDC’s Vaccines for Children (VFC) program provides free vaccines to eligible children through a network of 61 grantees and 44,000 enrolled providers. In 2010, approximately 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion. VFC providers must meet certain requirements for vaccine management, such as storing vaccines within required temperature ranges and monitoring expiration dates, to ensure that these vaccines provide children with maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse.

HOW WE DID THIS STUDY

Using CDC data, we selected a sample of 45 VFC providers from the 5 grantees with the highest volume of vaccines ordered in 2010. We conducted site visits at these providers’ medical practice locations, interviewed their vaccine coordinators, and observed their vaccine management practices. We also independently measured these providers’ vaccine storage unit temperatures for a 2-week period. Finally, we interviewed the five grantees’ VFC program staff regarding their program oversight.

WHAT WE FOUND

Although the majority of storage temperatures we independently measured during a 2 week period were within the required ranges, VFC vaccines stored by 76 percent of the 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period. Exposure to inappropriate temperatures can reduce vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases. Thirteen providers stored expired vaccines together with nonexpired vaccines, increasing the risk of mistakenly administering the expired vaccine. Finally, the selected providers generally did not meet vaccine management requirements or maintain required documentation. Similarly, none of the five selected grantees met all VFC program oversight requirements, and grantee site visits were not effective in ensuring that providers met vaccine management requirements over time.

WHAT WE RECOMMEND

We recommend that CDC continue to work with grantees and providers to ensure that (1) VFC vaccines are stored according to requirements, (2) expired vaccines are identified and separated from nonexpired vaccines, (3) grantees better manage providers’ vaccine inventories, and (4) grantees meet oversight requirements. CDC concurred with all four of our recommendations and noted that vaccination is one of the most successful public health tools in preventing and controlling disease.