Belief not science is behind flu jab promotion, new report says

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7856 (Published 19 November 2012)
Cite this as: BMJ 2012;345:e7856

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Belief not science is behind smallpox and polio jabs - CORRECTION.

In my letter published 16 December 2012, I inadvertently omitted some words from my quote of Dr. Parry, in relation to small-pox incidence and fatality being worse in the vaccinated than the unvaccinated:

The second last sentence of point 5 ought to read "In Germany, in 1919, there were 5,012 cases of small-pox with 707 deaths; in England in 1925 there were 5,363 cases of small-pox with 6 deaths."

Competing interests: None declared

Dr Viera Scheibner (PhD), Scientist/Author Retired

N/A, Blackheath, Australia

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Dear Sir,

Peter English should know that vaccine fallibility isn't the main issue for parents.

There are a lot of other vaccines which don't work at all well.

The USA has NEVER used the BCG vaccine, because the USA has always known that using a very poor vaccine isn't worth their time, effort or money.

Yet, the course of TB is the same in USA as it is in developed countries that proclaim to the rooftoops that the BCG vaccine saved everyone from tuberculosis.

Other vaccines have issues for those parents who look beyond the narrow frame of usage advice given which appears to be, "it's the best we have, however bad, and since we don't have any other treatments which we know about, we should use imperfect vaccines to the maximum extent possible."

Parents know that doctors prefer parents to not think, and "just do it". However, for parents who know how to think, Nike’s motto doesn’t work for them.

As Dr Cunningham pointed out, there are very real potential disadvantages to using a flu vaccine if physiologically, it's use is counterproductive in the bigger picture. But I disagree with Alan Cunningham that the flu vaccine is the one vaccine that undermines parent’s “faith”.

Parents who know the medical literature, are wary of many vaccines, as well as the ages at which some of them are administered.

Parents know that there are very significant disadvantages with many other vaccines as well, in the bigger picture. Parents are finding out for themselves from medical literature databases, what those disadvantages are, providing their doctors with medical articles, and ticking off all the vaccines which are not only imperfect, but potentially dangerous in their opinion.

The problem for the medical profession is that they have not yet computed that parents are wising up, educating themselves and their doctors… and that it's no longer possible to persuade parents who realise that the most potent lie isn't something said, but is something that is deliberately left unsaid.

More interesting is the position their doctors are starting to be put in - which is one of realising that they have also had the wool pulled over their eyes. Some have described it as being similar to trying to snooze on barbed wire, which doesn’t sit well with doctors who prefer to make science based decisions rather than political, faith or peer reputation based decisions.

Hilary Butler

Competing interests: None declared

Hilary Butler, freelance journalist

none, Harrisville Road, Tuakau NZ

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I've spent years watching this vaccine be used experimentally on patients with kidney disease, while they were told it was safe and effective. I've got numerous personal testimonies in my posession that speak otherwise. Just this AM I did a search on Pubmed and saw that even more reports are coming in regarding glomerulonephritis after vaccines in previously normal kidneys, and worsening of chronic kidney disease. All the patients I dialyzed after the flu shots now are living evidence that collateral damage happens and it can be unpredictably severe.

Yet each and every case was said to just be anecdotal by other doctors. Hopefully enough case reports have accumulated to show the risk benefit ratio favors just getting the flu. I've seen type I diabetics and transplant patietns who are supposed to do terribly ill after being infected with flu and H1N1 do just fine. I've walked into the ICU in isolation rooms expecting to find severely ill persons with flu, only to find them sitting up, eating, playing checkers with their families in masks.

So to me this vaccine is never worth the risk. Now, if doctors had a clue how to feed, nourish and treat a virally infected person with vit C imagine how different all the other cases who do get flu and have morbidity (which personally I've never seen even in my renal patients who refused vaccines young and old) would be.

Competing interests: None declared

suzanne humphries, nephrologist/physician

private practice, PO Box 300 lincolnville center maine 04850

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Belief not science behind smallpox and polio jabs

Jeanne Lenzer’s assertion, that “Smallpox and polio vaccines halted deadly scourges of their time.” is a belief unsupported by published evidence.

Smallpox vaccination never prevented smallpox, quite the opposite: it caused large outbreaks of the “dreaded disease” in their recipients. I refer Jeanne to the relevant discussion by medical doctors in BMJ (14th and 21st January) 1928. Dr. Parry raised the following questions:

1. How is it that small-pox is five times as likely to be fatal in the vaccinated as in the unvaccinated?
2. How is it that, as the percentage of people vaccinated has steadily fallen from about 85 in 1887 to about 40 in 1925, the number of people attacked with variola has declined pari passu and the case mortality has progressively lessened? The years of least vaccination have been the years of least small-pox and the least mortality.
3. How is it that in some of our best vaccinated towns – for example Bombay and Calcutta – small-pox is rife, whilst in some of our worst vaccinated towns, such as Leicester, it is almost unknown?
4. How is it that something like 80 percent of the cases admitted into the Metropolitan Asylum Board small-pox hospitals have been vaccinated whilst only 20 percent have not been vaccinated?
5. How is it that in Germany, the best vaccinated country in the world, there are more deaths [from smallpox] in proportion to the population than in England – for example, in 1919, 28 deaths in England, 707 in Germany; in 1920, 30 deaths in England, 354 in Germany? In Germany, in 1919, there were 5,012 cases of small-pox with 6 deaths. What is the explanation?
6. Is it possible to explain the lessened incidence and fatality of small-pox on the same grounds as the lessened incidence and fatality of other infectious fevers – namely, as due to improved hygiene and administrative control?

The ‘experts’ commented, “We think that Dr Parry in his desire for enlightenment would have been wiser not to introduce assumptions of facts into the framework of his questions.“ The editorial comment also accused Dr Parry of introducing assumptions of fact into his questions, while he was the one referring to the well-documented facts.

To this day the proponents of vaccination accuse those who oppose vaccination of expressing undocumented opinions while it is the other way around.

Harmful reactions and ineffectiveness of smallpox vaccination motivated the “eradication” campaign of the 1970s. Smallpox was pronounced eradicated on 8th May 1980, vaccination stopped and epidemics disappeared, bar small outbreaks of whitepox, buffalopox, monkeypox, camelpox and similar names, while the disease was indistinguishable from smallpox. According to Arita and Gromyko (1982. Bull WHO; 60 (4): 367-375), the main benefit of smallpox being pronounced officially eradicated was that vaccination could be discontinued in all countries. Simply, smallpox vaccination had become an embarrassment.

In early 2003, smallpox vaccination for selected segments of the US population was introduced. Many recipients developed serious cardiac events (MMWR; March 28 2002), myopericarditis (JAMA; 289(24): 3283-3289) cardiac death (MMWR; Oct 16 2003), focal and generalized folliculitis (JAMA; 289(24): 3290-3294) and other serious problems. The explanation offered was poor immunological status in general population, aggravated by immunosuppressive medication. Vaccination had to be abandoned.

Poliomyelitis (originally called provocation paralysis caused by unrelated foreign protein-containing vaccines) increased with polio vaccination already during the first poliovaccine trials, and then continued with mass vaccination. Instead of abandoning the ineffective vaccines the polio disease was reclassified (a disease with a residual paralysis resolving within 60 days changed into a disease with residual paralysis persisting for more than 60 days, seemingly resulting in eradication of 90% cases, since the majority of polio paralysis cases resolved within 60 days) and new names introduced: Guillain-Barre syndrome, ascending paralysis, viral meningitis. The vaccine type of polio-virus-associated paralysis cases have predominated (60,849 cases in India in 2011) ever since then, yet the proponents of vaccination have been claiming the vaccination success, so well described by Ron Law (BMJ.com rapid response, 10th March 2012, with a telling graph): “And the professor [David Colquhoun] rests his case that polio is no longer rampant while reclassified polio-like paralysis continues unabated…Perhaps the good professor could explain how reclassifying a disease and then claiming eradication of the disease is a medical success?”

Perhaps the most disconcerting but neglected element in the poliomyelitis vaccination debate is the continuing potential contamination of polio vaccines by monkey viruses such as SV40 (being the one best researched, while the possible deleterious effects of the majority of the monkey viruses remain unaddressed), and chimpanzee coryza virus (renamed respiratory syncytial virus), linked to many types of cancers and dangerous lower respiratory tract infections, respectively (Scheibner, BMJ.com rapid responses to “Polio eradication: a complex end game” of 3rd, 24th, 26th and 27th August 2012).

Recommended reading:
Peterson et al. 1955. JAMA; 159(4): 241-244; Abraham et al. 1993. J Infect Dis; 168: 1005-1009; Hilleman and Sweet 1960. Proc Soc Exp Biol and Med; 105: 420-427; Gerber et al. 1961. Proc Soc Exp Biol and Med; 108: 205-209; Eddy et al. 1961. Proc Soc Exp Biol and Med; 107: 191-197; Fenner 1962. BMJ; 21 July: 135-142; Weiner et al. 1976. NEJM; 286 (8): 385-389; Bergsagel et al. 1992. NEJM; 326: 988-993; Butel and Lednicky 1999. J Natl Cancer Res; 91: 119-134; Carbone et al. 1997. Nature Med; 3 (8): 908-912; Kops 2000. Anticancer Res; 26: 4745-4750; Chanock and Finberg. 1957. I. Am J Hyg; 66: 281-290; Chanock and Finberg. 1957. II. Am J Hyg; 66: 291-300; Mensi and Pregliasco 1998. Clinical and Diagnostic Laboratory Immunology; 5 (3): 278-280; Sutter et al. 1991. Lancet 338:715-720; Biellik et al. 1994. Lancet; 344: 1776; Kim-Farley et al. 1984. Lancet; 8 December: 1322-1324; Ogra. 1995. Ann NY Acad Sci; 97-107; Furione et al. 1993. Virology; 196: 199-208; Carbone et al. 1994. Oncogene; 9: 1781-1790; Neetu Vashisht and Jacob Pulliel. 2012. Indian Journal of Medical Ethics; IX(2).

Competing interests: None declared

Dr Viera Scheibner (PhD), scientist/author retired

n/a, Blackheath, Australia

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In January 2000, just before the ACIP added annual flu shots to the U.S. immunization schedule for young children, Kenneth McIntosh said: "Randomized trials of the safety, effectiveness and cost-effectiveness of influenza vaccination of infants and toddlers should be conducted in populations large enough to identify any risks of rare adverse events and should be continued through several epidemics--long enough to establish their worth....Such studies would enable us to evaluate the benefits, risks and economic effects before we consider any national recommendation....The benefit-risk ratio would need to be very high, given the relatively small proportion of cases of severe respiratory illness that would be prevented, the probable need for more than one dose, the uncertainties and unpredctability of antigenic variability, and the need to immunize during a period when many other vaccines are given." (Editorial. NEJM 342:275, 2000) Dr.McIntosh's advice was ignored and we now recommend annual flu shots cradle-to-grave. The recent CIDRAP report just asserted that the expansion of flu vaccine recommendations in recent decades has NOT been based on scientifically sound data.

In spite of influenza vaccine's enormous commercial success we still lack the data to know if they have done more good than harm. Prior receipt of seasonal flu shots significantly increased the risk of pH1N1 infections during the 2009-10 pandemic (Skowronski. PLoS Med 2010) and Bodewes and colleagues refer to the "double-edged sword" of yearly influenza vaccinations because they prevent the induction of heterosubtypic immunity to pandemic strains in animals and children. (Lancet Inf Dis 9:784,2009. J Virol 86:11995, 2011) The question may become moot if, as some of us hope, a universal flu vaccine is forthcoming.

I believe that the flu vaccine juggernaut is one factor that undermines public confidence in the vaccines we really need.

Competing interests: None declared

Allan S. Cunningham, Retired Pediatrician

Cooperstown, NY--USA, Box 386, Cooperstown, NY 13326

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We fully agree with Dr Hugh Mann. The financial issues obscure the main priorities of safety and public health.

Flu vaccines raise a lot of questions among which the important ones are as follows:

- What about the safety of formaldehyde, that is a well known carcinogen (class I)and that is contained in a majority of flu vaccines (1) ? Why is carcinogenesis never required during the evaluation process of vaccines (unlike other drugs)?

- What about the special risks for pregnant women who are vaccinated? An interesting article of Mrs Ellen Danneman exposes a sharp increase of foetal mortality of more than 4000% following the H1N1 vaccination for pregnant women (based on VAERS data). Officials know it but still recommend this shot to this sensitive public! (2)

- How can we explain the mortality statistics derived from the CDC Vital Statistics Reports Covering Years 1999-2003 and the rising influenza deaths rate among children under 5 in 2002, just after that CDC mandated early childhood flu vaccines in USA (passing from 25 deaths per year in 1999 to over 90 in 2003, while the implementation of flu vaccination in children occurred in the latter half of 2002) ? (3)

The problem is not only about flu vaccines, it is about all of them. The issue of the benefit/risk of these products still remains very sensitive. For example, here in Belgium, the Office of Birth and Childhood (ONE) indicates that vaccines campaigns against pertussis began in Belgium when the incidence of invasive infections was about 44/ 100 000 children (4) BUT in 1996, the Swedish study of Gustafsson & al., published in NEJM, showed a very frightening rate of serious side effects with the acellular version of the vaccine: nearly 1 in 200 vaccinated children (48/10000) in a period of 1 to 60 days following the shots (5) ! We do have this way a vaccine that is at least 10 times more risky than the hypothetic complications of the natural disease!

And unfortunately, that is just the same with Hib vaccination: in 1999, Dr J. B Classen wrote a letter to the BMJ (6) in which he denounced the absence of any long term safety study for vaccines. Here is some parts of his quote: "[...]immunisation starting after the age of 2 months is associated with an increased risk of diabetes. Our analysis is further supported by a similar rise in diabetes after immunisation with H influenzae type b vaccine in the United States4 and United Kingdom.5 Furthermore, the increased risk of diabetes in the vaccinated group exceeds the expected decreased risk of complications of H influenzae meningitis. Research into immunisation has been based on the theory that the benefits of immunisation far outweigh the risks from delayed adverse events and so long term safety studies do not need to be performed. When looking at diabetes—only one potential chronic adverse event—we found that the rise in the prevalence of diabetes may more than offset the expected decline in long term complications of H influenzae meningitis. Thus diabetes induced by vaccine should not be considered a rare potential adverse event. The incidence of many other chronic immunological diseases, including asthma, allergies, and immune mediated cancers, has risen rapidly and may also be linked to immunisation."

For hepatitis B vaccine, it is one more time the same because there is no real risk of hepatitis B before the age of +/- 15. Thus, the risks appear greater than the potential benefits. A recent research shows that hepatitis B vaccine induces apoptosis of hepatic cells.(7) The study of Tardieu and Mikaeloff in 2008 in Neurology showed an increased risk of multiple sclerosis (2,57) in children vaccinated with all recommended shots, included hepatitis B vaccine.(8) In Belgium, a confidential document of more than 1200 pages about the pharmacovigilance of Infanrix hexa has just been disclosed to us a few days ago by an employee of the National Drug Regulation Agency (AFMPS). This document mentions 36 infant deaths for the 2 years period of 2009-2011 but at least 37 other sudden deaths since launch of the vaccine, in 2000. This document listed 825 various possible side effects and all the systems of the body can be involved. Autism, child abuse syndrom and diabete of SIDS are mentioned for example. At the end of the document, we can see that several comments (of physicians but also of national regulatory agencies like italian one) establish a possible or likely link between the death and the vaccine. We noticed a very abnormal temporal distribution of the deaths, with a clear concentration of the fatal outcomes in the first days (or hours) after vaccination, most often delivered with concomitant others, like Prevenar/Synflorix or Roratix/Rotateq

This kind of document shows clearly the urgent need of real comparative studies with real placebos. We must dare comparing what it is comparable: vaccinated with completely unvaccinated children, because it is the only method that is really a scientific one! We cannot accept any longer inconsistent pretexts claiming that it is impossible because it would be "unethical". What is the most unethical of all is carry on exposing various generations to insufficiently assessed (=experimental) products!!

References:

(1) http://ntp.niehs.nih.gov/ntp/roc/twelfth/profiles/formaldehyde.pdf

(2) http://vactruth.com/2012/11/23/flu-shot-spikes-fetal-death/

(3) http://www.cdc.gov/nchs/data_access/Vitalstatsonline.htm

(4) http://ddata.over-blog.com/3/27/09/71/2012-2013/ONE-on-pertussis-inciden... (NB: Extract of The Guide of Preventive Medicine of the ONE, The Birth and Childhood Office in French speaking Belgium)

(5) Gustafsson L. & al.,” A controlled trial of a two-component of acellular, a five-component acellular, and a whole-cell pertussis vaccine.”, (The New England Journal of Medicine, t. 334 [6], p349-355; 1996).

(6) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1114674/?tool=pubmed

(7) http://www.ncbi.nlm.nih.gov/pubmed/22249285

(8) MIKAELOFF Y, CARIDADE G, SUISSA S, TARDIEU M. “Hepatitis B vaccine and the risk of CSN inflammatory demyelination in childhood” Neurology 2008
http://www.neurology.org/cgi/content/abstract/01.wnl.0000335762.42177.07v1

Competing interests: None declared

Sophie Meulemans, vigilant citizens

Muriel Desclée, Marie-Rose Cavalier

Initiative Citoyenne (Belgian health watchdog), Rue de Gesves, 22, 5340 Faux-Les-Tombes, Belgium

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Drs English and Hewitt seem to misunderstand the article. They claim that I am guilty of the "perfect solution" fallacy regarding flu vaccination. I beg to differ. I cited data besides the CIDRAP report, specifically the Cochrane reviews, which reported lack of efficacy for flu vaccine in several populations.

Importantly, I pointed out that both CIDRAP and Cochrane did not find mortality benefit among the elderly, who account for over 90% of all flu deaths (most of the other deaths occur among those with multiple co-morbidities).

The modest (but hardly complete) benefit seen in healthy younger adults and lack of effect on those who need it most (the elderly) raises a quandary similar to that of prostate cancer screening and treatment described by Willet Whitmore who famously asked, “Is cure necessary in those for whom it is possible, and is cure possible in those for whom it is necessary?”

My article simply stated the facts about the known efficacy of flu vaccine - something the author of the CIDRAP report himself said has been exaggerated and even hyped at times. So I'm puzzled by the rather strong reaction it evoked by Drs English and Hewitt.

As for comments by other readers regarding drug company hype and links to autism; unfortunately, some of the "science" claimed by those who are opposed to vaccines is as bad as that of the proponents of certain vaccines. Smallpox and polio vaccines halted deadly scourges of their time. At the same time, infants and children today are given stunning numbers of vaccines by the age of 5 years, and while some are good, others leave far more room for doubt, and vaccines have indeed become big business, especially as lucrative Department of Defense and bioterrorism contracts have funded vaccine stockpiling and research.

I think what is needed to distinguish the wheat from the chaff is more sound science, not advertising or fanciful thinking disguised as science - which brings me to BMJ's commendable campaign for data transparency: something that is sorely needed if we are to learn which vaccines are necessary, which are borderline, and which we might want to forego altogether.

Jeanne Lenzer

Competing interests: author of article on flu jabs

Jeanne M. Lenzer, journalist

independent, 19 Ridge St., Kingston, NY 12401 USA

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I was disappointed to see this news item, which misrepresents the CIDRAP report.

The author has fallen for the "Nirvana" or "Perfect solution" fallacy: the idea that if a solution isn't perfect, it should not be implemented.

The CIDRAP report does say that the currently available flu vaccines are not so good that we should be complacent enough to not fund better vaccines. But the report acknowledges that the vaccine does have a useful role in preventing serious disease.

The vaccine is "good enough" to be worth using as it is in the UK. It is not so good enough for us not to be looking for a better vaccine.

Problems with the current vaccine are well described in the report:

- There is inadequate evidence that it is effective in old people (which may or may not mean that immunosenescence means it is ineffective. We do know that it is much more effective in younger people - part of the reason for the proposal to vaccinate children against flu (though not before autumn 2014) is that children act as very effective vectors for flu and other respiratory infections: they are more infectious than adults when ill, and they remain infectious for longer.

- Because of the constant mutation of the parts of the virus targeted by current vaccines a new vaccine is required every year or so; so an annual vaccination programme is necessary.

- Even in younger age groups the vaccine is not as effective as we'd like it to be (which is NOT the same thing as saying that it is not effective enough to be worth using - that's the Perfect Solution Fallacy).

- An ideal vaccine could not only be given only once (or at worst, with a priming course and then no or only very occasional boosters); but it would also be given without requiring the injection that seems to put people off. It goes without saying that it should - like the current vaccines - also be extremely safe.

So there is, as the CIDRAP report says, good reason to be working on better vaccines.

The BMJ piece picks up on concerns about mandatory flu vaccination. This seems to fail to recognise that the report relates to the situation in the USA where in some states or hospitals mandatory vaccination of staff is required.

There is no proposal that flu vaccination should be mandatory for health care staff in the UK, so concerns about this are misplaced.

Readers may be interested in my - rather hastily written, but referenced - blog on this "Dont rubbish flu vaccine just because it's not perfect", http://peterenglish.blogspot.co.uk/2012/11/dont-rubbish-flu-vaccine-just... and in the much better piece on the NHS Choices web site http://www.nhs.uk/news/2012/11November/Pages/Claims-flu-jab-is-waste-of-... .

Competing interests: I have received honoraria for attending vaccine "boards" (which gather experts to discuss vaccine policy), and expenses to attend professional conferences. I am editor of Vaccines in Practice magazine, which is supported by Wyeth Pharmaceuticals.

Peter M B English, Public Health Doctor

N/A, Chessington, Surrey

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Consequences of scientific fallibility

Peter English is right to take the BMJ to task for falling for the 'perfectibility fallacy, that if a new vaccine or treatment is not 100% reliable in its efficacy it should not be used until it is made reliable. But the impossibility of perfect science, or the fallibility of science, raises further questions he does not address. No scientific finding is perfectly valid because all sciences are prone to fallibility, some more than others. In the pecking order of fallibility medicine comes some way down: today's acclaimed treatments and vaccines are eventually replaced by 'better' treatments further down the line and have a relatively short shelf-life. Popper's thesis that good science rests on testable claims that are refutable is perhaps the most well-known version of the scientific fallibility thesis. The questions that then arise are what degree of imperfection or 'good enough-ness' is acceptable in medicine; and what scientific criteria can help medicine to answer this question?

The worry is that these questions are rarely addressed and when addressed are removed from public debate. Public concern about certain treatments and vaccines is partly the result of the failure of public health to come clean on these questions about the consequences of the fallibility of medical science. The 'public' in public health carries public responsibilities beyond just trying to keep us all healthy and free of disease.

Competing interests: None declared

Martin Hewitt, retired academic

none, London, N22

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20 November 2012

Vaccines are Big Pharma’s sacred-cash cow. As such, vaccines enjoy the hype and hoopla of media, with no real scrutiny. It’s curious that there is no attention paid to the fact that the exponential growth of vaccines parallels the exponential growth of allergies, autism, cancer, and autoimmune diseases. Are vaccines compromised by multimorbidity and iatrogenesis? And would the media tell us the truth?

Competing interests: None declared

Hugh Mann, Physician

Retired, Eagle Rock, MO, USA

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