Influenza: marketing vaccine by marketing diseaseBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f3037 (Published 16 May 2013) Cite this as: BMJ 2013;346:f3037
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To whom it may concern,
I am concerned regarding the reporting of statistics in this article. I don't believe this statistic, quoted directly from the article, makes sense (vaccine effectiveness was 27%; 95% confidence interval, 31% to 59%). When I compared this with the reference supplied (Reference 10), I could not find the statistic in the paper and was not able to locate the relevant data table to attempt calculations myself. This may be as a result of my access to view these articles. However, I am confused by this finding. Could this please be clarified by another?
Competing interests: No competing interests
We have carefully read the interesting Feature of Peter Doshi published in the BMJ (1) regarding influenza vaccination in the U.S. Nevertheless, an inappropriate reading could lead to inaccurate conclusions. Thus, we would like to emphasize the following points and provide evidence for discussion:
1) According to the Advisory Committee on Immunization Practices (ACIP), the influenza vaccine is not mandatory but is recommended in the U.S.(2); therefore, the need should be evaluated individually by a person and his/her physician in each particular case, according to individual characteristics;
2) there is evidence of the positive effect of previous seasonal vaccination in the case of a pandemic (3,4);
3) as documented by the World Health Organization (WHO), there is evidence of the benefits of the seasonal influenza vaccine among high-risk groups, particularly pregnant women, persons over 65 years of age, health care workers, and persons with HIV infection (5,6);
4) contrary to Doshi’s paper, a recent publication by Kostova and colleagues (7) documents the illness and hospitalizations averted by influenza vaccination in the U.S.
We recognize that the economic interest of the private pharmaceutical companies can influence the scenario, and that is why independent clinical research should be conducted, regardless of everyone’s conflicts of interests (i.e., researchers, companies, and institutions). Instead of presenting confounder arguments, health care workers should responsibly promote all of the prevention measures (including vaccination), particularly among high-risk groups.
1. Doshi P. Influenza: marketing vaccine by marketing disease. BMJ 2013;346:f3037.
2. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP)- United States, 2012-13 influenza season. MMWR. Morbidity and Mortality Weekly Report 2012;61(32):613-8.
3. García-García L, Valdespino-Gómez JL, Lazcano-Ponce E, Jiménez-Corona A, Higuera-Iglesias A, Cruz-Hervert P, et al. Partial protection of seasonal trivalent inactivated vaccine against novel pandemic influenza A/H1N1 2009: case-control study in Mexico City. BMJ 2009;339:b3928.
4. Eick-Cost AA, Tastad KJ, Guerrero AC, Johns MC, Lee SE, Macintosh VH, et al. Effectiveness of seasonal influenza vaccines against influenza-associated illnesses among US military personnel in 2010-11: a case-control approach. PloS One 2012;7(7):e41435.
5. World Health Organization (WHO). Vaccine position papers. Available at (http://www.who.int/immunization/documents/positionpapers/en/, 2012).
6. World Health Organization (WHO). Vaccines against influenza WHO position paper - November 2012. WER 2012;87(47):461-76.
7. Kostova D, Reed C, Finelli L, P-Y C, Gargiullo PM, Shay DK, et al. Influenza illness and hospitalizations averted by influenza vaccination in the United States, 2005–2011. PloS One 2013;8(6):e66312
Competing interests: BIRMEX is a non-profit State-owned company of the Mexican Ministry of Health that is responsible for providing the influenza vaccine for National Immunization Campaigns.
Current influenza vaccine strategies may be a waste of money, but influenza is not just a manufactured gimmick. Public health data connects influenza to many mental health and developmental disorders. Influenza often immediately precedes the first episode of autoimmune disorders. Combined with a mild bacterial infection, influenza can turn deadly. Vaccines might prevent some of these secondary effects. Or vaccines might create the same conditions that natural infection does and contribute to these bad outcomes. Researchers need to do a better job testing for influenza and recording all types of bad outcomes from infection and from vaccination – including long term effects.
Could surviving the flu make you more susceptible to the next one? Could vaccines reproduce this hazard? Avian H7N9 influenza in China has an unusual demographic – a high proportion of the victims are elderly men. Perhaps they have more exposure to poultry farms, but elderly men are also the most likely demographic to be vaccinated against previous influenzas. This is a clue that influenza may be like dengue fever – exposure to one strain may make you more susceptible to another strain.
A retrospective study comparing 2009/2010 and 2010/2011 pH1N1 influenza data in the UK showed that there were more hospitalizations and deaths from laboratory confirmed pH1N1 in the flu season following the massive vaccination campaign (2010/2011). Researchers in Spain noted a similar increase in bad outcomes the year after the pandemic response.
Real world studies of vaccine effectiveness have shown that having children is a better predictor of influenza infections than vaccination status. Ohmit et al report in Clinical Infectious Diseases that if one member of your household has influenza then vaccination does not protect you from influenza infection, in fact repeated vaccination was shown to lower the effectiveness in all settings, not just at home. Clearly antibody titers are not the best predictor of effectiveness of influenza vaccine.
Adverse events to vaccines may provide some clues about how influenza causes harm. Narcolepsy cases associated with the influenza vaccine Pandemrix are indicative of the subtle harm that influenza infection causes. Narcolepsy is an autoimmune neurological disorder of sudden onset sleeping symptoms. E. Miller (UK-HPA) notes, “There is a strong association with human leucocyte antigen (HLA) DQB1*0602 and reported associations with environmental factors such as streptococcal infection, seasonal influenza, and more recently pandemic A/H1N1 2009 influenza.” Children in Europe developed narcolepsy after receiving an adjuvanted pandemic flu vaccine, Pandemrix. Neurologist John Shneerson brushed off the reactions in an HPA statement saying "Pandemrix may have triggered an immune reaction against the sleep centre cells in those children who were genetically predisposed to develop narcolepsy.”
Indeed, inoculated children who developed narcolepsy had the risky HLA-DQ type, and maybe they would have developed narcolepsy after being exposed to influenza that season anyway even if they hadn’t been vaccinated. But this reveals another mechanism of influenza pathology –viral infections often trigger the first episode of autoimmune disorders. For narcolepsy, the vaccine was as bad as the natural influenza infection, but the vaccine was given by choice.
Can we make better vaccines that don’t trigger these autoimmune disorders? We need to understand what part of the immune response triggers autoimmune symptoms, to safely fight pathogens without turning our immune systems on ourselves.
My son is autistic. New research shows autism is a birth defect – there are changes in the brain and the placenta that are present at birth, but are not part of any regular testing. Current healthcare practices can only reliably detect autism at 2 years old, so babies that look healthy at birth could still be autistic. Autism is associated with immune activation in mother and child, and antibodies have been detected in moms of autistic kids that can cause autism in animal models. Being infected with influenza or having a fever during pregnancy is associated with a higher risk of autism in the offspring (also a higher risk of schizophrenia and bipolar disorder.)
Could prenatal influenza vaccination cause autism by creating cross reacting antibodies, or stimulating the maternal immune system, or just by causing fever? The US-CDC will tell you “no,” because studies show that babies born to vaccinated mothers are healthy at birth, and, like narcolepsy, no one has EVER reported autism in VAERS following prenatal vaccination. That’s amazing!! You would expect at least 1% of kids born to vaccinated moms would develop autism.
Could prenatal vaccinations prevent autism? Maybe, but no one has bothered to do the studies. Thousands of women have been vaccinated against pandemic H1N1 in 2009/2010 in vaccine studies. Most of these studies ended when the children were born – some went as long as 7 months – too young to diagnose autism. But these kids are 2-3 years old now. Researchers should be calling these women to ask if their babies are meeting their developmental milestones. This follow-up would give us better data about whether influenza vaccines are really making a difference, or are causing more harm than good.
Maybe the problem is not that the influenza virus causes the worst outcomes, but rather an unknown synergy between influenza and other organisms turns the encounter deadly. Rather than cheap vaccines in the drugstore, how about cheap and easy flu testing? Followed by a serum antibody titer, and real storage of the old serum samples. Also check for commensal bacteria at the time of influenza diagnosis, so that cultures are grown and sensitivities completed before the patient comes down with a secondary infection. You could even treat risk groups with antibiotics at the time you diagnose the first flu to prevent secondary infections. Early testing and storage of serum samples will give us a better way to ask questions in a retrospective way and to know that we are using the right treatment for the right disease – think Framingham Heart Study on a global level. China does this for poultry market workers.
Early testing, researching the deadly interactions between influenza and bacteria, understanding viral triggers for autoimmune disorders, developing vaccines based on targeted technology, and following thorough with long term safety testing is the right course for eliminating influenza.
Competing interests: No competing interests
The arguments put forward by Doshi primarily address what he considers to be inaccuracies in the statements and reports of the CDC. For example, the author highlights two observational-based studies that the CDC cites to justify the case for influenza vaccination in the elderly (2, 3). Doshi argues that these studies have been identified as providing inaccurate estimates of vaccine efficacy (4).
It may be that Doshi raises some reasonable concerns about the references cited and statements made by those who are in favour of influenza vaccination in the elderly. However, the identification of any potential misstatements by such parties should not be what decides vaccine policy. Vaccine policy should be informed by careful evaluation of the evidence itself, not by an evaluation of the accuracy of those citing it.
I believe that many readers of the article would take away the message that there is, as Doshi puts it, “virtually” no evidence to support influenza vaccination of the elderly. However, this statement by Doshi only refers to his assessment of the evidence for the prevention of influenza mortality. For other outcomes there is more evidence. For example, the Cochrane review for the elderly reports a statistically significant vaccine efficacy against influenza from the (albeit limited) randomised control trial data (5).
The prevention of influenza would prevent all subsequent disease outcomes from this infection in any protected elderly individual, i.e. if you do not become infected you can not suffer complications from infection. To suggest that the program does more harm than good, it would need to be shown that any adverse events at least outweighed the benefits of preventing these outcomes. This is true even if those elderly more likely to be protected were found to have a lower risk of influenza mortality.
The more relevant question may be if the program represents value for money given the potential alternative uses for the healthcare resources. However, it could be that even a vaccine program that prevents less influenza mortality than was hoped may still do enough good to be cost-effective.
1. Doshi P. Influenza: marketing vaccine by marketing disease. BMJ 2013;346:f3037
2. Gross PA, Hermogenes AW, Sacks HS, Lau J, Levandowski RA. The efficacy of influenza vaccine in elderly persons: a meta-analysis and review of the literature. Ann Intern Med 1995;123:518-27.
3. Nichol KL, Nordin JD, Nelson DB, Mullooly JP, Hak E. Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med 2007;357:1373-81.
4. Simonsen L, Reichert TA, Viboud C, Blackwelder WC, Taylor RJ, Miller MA. Impact of influenza vaccination on seasonal mortality in the US elderly population. Arch Intern Med 2005;165:265-72.
5. Jefferson T, Di Pietrantonj C, Al-Ansary Lubna A et al. Vaccines for preventing influenza in the elderly. Cochrane Database Syst Rev 2010;(2):CD004876.
Competing interests: ATN has in the past received research funding from a manufacturer of influenza vaccine for other projects
Continuing on from my last response, just a few more words.
For those who might have curled their lips saying, "How could she know -
there was no control?" - here is what I missed out of my first letter.
Over a period of about 2 years, there were many times when I made sure I got to
admitting patients and countermanded the orders, refusing to allow vaccines
to be administered to those whom I was consulted on.
I was able to observe over that time, how much easier it was to make a diagnosis without having to look through the confusing layers of acute illness combined with potential acute vaccine reactions.
It didn't take long to realize that the unvaccinated had a much smoother
shorter hospital delay with fewer secondary complications and that it was
far easier to figure out what was actually going on.
It was comparing the two groups, which made me really sit up and think.
When I went to find the studies proving that vaccines were safe for
seriously sick acute admission patients I could find no evidence at all.
When I presented my evidence comparing vaccinated and unvaccinated patients
to the hospital administration, I was told that in order for it to be validated, I should do my own study comparing vaccinated and unvaccinated.
Which is bizarre, when you consider that that sort of "evidence" should be
provided by the vaccine manufacturer, not a doctor trying to "do no harm"
and create the very best outcome for those who came seeking help.
Dr Suzanne Humphries
Competing interests: No competing interests
On the topic of disease mongering, what about the questionable ethics of the US National Institutes of Health funding research into making bird flu (H5N1) more transmissible, ostensibly to pre-empt Nature and to facilitate production of vaccines…?
You couldn't make it up…
For the perspective of an 'Independent Vaccine Investigator', refer to my submissions regarding the ethical implications of 'lethal virus' development, also questioning fear-mongering in the influenza industry:
- A submission to the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) re Opposition to Lab-engineering of Potentially Lethal Pathogens (17 December 2012): http://users.on.net/~peter.hart/Submission_to_CDC_HHS.pdf
- An open letter to the National Science Advisory Board for Biosecurity re the political and ethical implications of lethal virus development (31 January 2012): http://bit.ly/AfyAtQ
And here's another example of questionable influenza research: 'Appalling irresponsibility': Senior scientists attack Chinese researchers for creating new strains of influenza virus in veterinary laboratory: http://www.independent.co.uk/news/science/appalling-irresponsibility-sen...
Research into potentially lethal pathogens appears to have blossomed in an over-the-top response to bioterrorism attacks in the US in 2001.(1,2)
Perhaps this research has the potential to do more harm than good?
I suggest we need critical analysis of what is going on, and who is really benefiting from the empire-building and enormous sums being spent in this area.
1. Erika Check Hayden. The price of protection. Nature. Vol. 477, 9 September 2011, pp 150-152.
2. Erika Check Hayden. Pentagon rethinks bioterror effort. Nature. Vol. 477, 22 September 2011, pp 380-381.
Competing interests: No competing interests
I left my position as a hospital based Nephrologist in June 2011 after 2 years of attempting to convince the administration they were making a mistake by vaccinating very ill patients on their first day of admission often before a diagnosis had even been made. CHF, sepsis, acute kidney injury, severe renal failure in cancer patients getting IV chemotherapy were not reasons to with hold the influenza or pneumonia vaccines in these unsuspecting people.
If the vaccine sounded like a good idea to the patient, after the pharmacist described the availability and CDC recommendations from a one page brochure, the order was entered into a computer, with a physician's name, and the shots were dutifully administered by the RN, with no need for actual physician approval. It was built into hospital policy.
Any downfall in the patient's health after that was though to be a figment of my imagination, even when I held solid evidence in my hand with graphics of the rise in creatinine within 24-48 hours after the vaccine was given, when nobody else could implicate anything else. when I brought these cases in front of the administration and the chief of medicine I was told that it was not the vaccine and that the vaccines were safe and effective.
And I was asked what was wrong with me. "Smallpox was eradicated by vaccines. Polio went away after vaccines." I researched these two often parroted claims and was shocked to find enormous volumes of literature and vital statistics that undermine these long held mythologies.
I wrote a 12 page paper with over 40 references to support my claim that vaccines can contribute to kidney failure and worsening of pre-existing inflammatory disorders.
I asked simply that the vaccines be with held until the last hospital day, instead of the first. After a meeting to discuss my concerns, I was informed that the hospital vaccine policy would remain as is, and that I was confusing the nursing staff by dc'ing orders for vaccines.
I'm only writing a small segment of what really occurred to give you some idea. There was much more, and many wounded and died after influenza vaccines both in and out of the hospital.
Another response I got from another colleague was that that denominator was so huge on vaccines that my cases did not mean much. I doubt the spouse of the patient who died after major surgery and vaccination with new onset kidney failure felt that way. I doubt that those who had to remain in hospital for weeks longer and go onto temporary dialysis felt that way. And I never could understand why the insurance companies didn't care, since these vaccine reactions were costing them hundreds of thousands of dollars per patient, more.
I don't know what part of the medical profession will ever get this. Once in a while another doctor would tell me that she/he did not get their own flu vaccines but they were still giving them to their patients. They would not listen to me, and did not want to know.
If they did listen and agree, they may have landed up where I did, doubting the ethics of recommending committees, doubting the necessity of other drugs I was taught were the only way, the best way. Realizing that many other things I was taught were incomplete and driven by pharmaceutical interests.
All that will take a respected nephrologist like me from the land of respect and preference to the land of "quacks" overnight. It is dangerous for doctors to think on their own, to disagree with the practices they are encouraged to carry out. I really thought my administration would care and listen to me, and I was thrown back on my heels by what happened. They had to keep up vaccine rates in hospitalized patients and I was a cog in the wheel.
Competing interests: Physician who refuses to recommend vaccines to sick patients, and believes they are unnecessary and toxic to the rest of us too. Still looking for that evidence of safety and effectiveness I was assured of.
Here in our model, modern, Western Democracies (the UK and the USA), we could dismiss Dr Vlassov's account of Russian Flu Vaccine reactions as things that happen in totalitarian regimes. No opportunity for market competition. No freedom for the physician to do his best for the patient who is a supplicant in front of him.
We could teach the serfs a thing or two.
Here, in the Land of the Free (USA) and the Mother Country of the Commonwealth, the Empire (the UK), we have the spectacle of Marketing Disease, Drugs of Poor Benefit being issued for use by our Democratic Government - please see Dr PM English's rapid response - the promotion of vaccination programmes without answering queries raised in the Rapid Responses (a debating forum meant to look at issues of interest in Medicine, as highlighted in the BMJ - please see the contributions from Dodge, Struthers, Havinga, Anand ie, myself ) in All Rapid Responses in the past one month.
The tacit acceptance of the government policies and practices by the GPs, Consultant Physicians, Public Health Physicians, Academics, the refusal to debate; in effect deafening silence.
Does all the above make us in the UK and the US, the shining beacon that the dark, unenlightened Third World should travel to?
Answers, please, to the specific points raised in the previous rapid responses. This is merely a pointer.
Competing interests: Still seeking facts
It is notable that P. Doshi mentioned only two cases of side effects of flu vaccination. In reality the sporadic side effects are quite numerous, but because of their 'flu-like' nature they are not reported.
In Russia the vaccines produced locally (side effect of the support to national businesses) are bought by Government for 'free" vaccination.
Children in schools and kindergartens are the most prevalent subjects forced to be vaccinated for free. Almost every year in one or another region of Russia the vaccination is stopped because of the reports of the mass suffering of children from the side effects of vaccination. Usually the specific series of vaccines are recalled.
The pressure on physicians to use the already prepaid vaccines is so strong, that they fill the patients' records with false statements of vaccination. We know about this accidents, because from time to time here and there the criminal cases are opened against these physicians.
Competing interests: No competing interests
"Public policy making is not an exact science but should as far as possible be based on robust publicly available evidence that can be fully assessed by external stakeholders." http://www.bmj.com/content/345/bmj.e5986?sso=
I agree with prof Azeem Majeed, but at the same time I have the feeling that leaders are suppressing well known concerns about 'non-specific' vaccine effects.
Nevertheless, I can imagine a BMJ theme issue with the focus on the importance of infectious diseases for health.
Frank Ryan's book Virolution sets the stage for a medical paradigm shift with reference to the idea that infections are bad. http://www.fprbooks.com/page6.htm
Peter Aaby is perhaps the only person who has consistently investigated the impact of vaccines, even though it only covers mostly the effect on morbidity and mortality due to acute infectious diseases that are targeted by vaccines. He summarized that in this article; "Vaccine programmes must consider their effect on general resistance" BMJ 2012;344:e3769
Viruses make up 43% of the human genome. Basically, viruses are like DNA and they can incorporate themselves into human DNA. "Viruses use - miRNAs to manipulate both cellular and viral gene expression. Furthermore, viral infection can exert a profound impact on the cellular miRNA expression profile" http://www.ncbi.nlm.nih.gov/pubmed/20477536
Take the mumps virus as an example, could mumps be protective against gonadal tumors? http://gaia-health.com/gaia-blog/2012-10-09/mumps-protects-against-ovari...
Overall there is an increase in the incidence of cancer http://www.cancerresearchuk.org/cancer-info/cancerstats/incidence/all-ca...
and Latin America http://www.thelancet.com/commissions/planning-cancer-control-in-latin-am...
and Africa http://www.thelancet.com/series/cancer-control-in-africa seem to catch up with developed countries. However, the 'non-specific' effects of the increasing amount of received vaccines are consistently ignored.
Also bacteria part in our genomic make-up: "There are more microbial genomes than human cells. We're a walking ecosystem" http://www.sciencemag.org/site/products/lst_20130510.xhtml Are vaccines against bacteria, that were part of the commensal flora (microbiome), associated with the increasing trends in Crohn's disease, Ulcerative Colitis, asthma, eczema, or autoimmune diseases such as NIDDM, hypothyroidism, etc?
Could the impact of the gut microbiota on brain and behaviour http://www.nature.com/nrn/journal/v13/n10/abs/nrn3346.html point to an association between the increase in vaccines and pervasive developmental disorders like autism?
The perceived benefit of vaccines in the developing countries is confounded by the reality that the main issues why children die from acute infectious diseases are poverty, malnutrition, overcrowding and hygiene. https://www.youtube.com/watch?v=bsWHiQfwxBc and that long term issues like NCD are systematically ignored.
Indeed, theme issues in medical journals and international (WHO) conferences with the focus on the benefits of acute infectious diseases as natural preventative gene therapy for the future health of the individual are long overdue. http://www.bmj.com/content/344/bmj.e3769/rr/593438
Unfortunately the current 66th World Health Assembly's Draft Action Plan for the prevention and control of noncommunicable diseases 2013–2020 does not mention this in objectives 5 and 6 http://apps.who.int/gb/ebwha/pdf_files/WHA66/A66_9-en.pdf In fact, the appendix on Communicable Diseases, maintains the current prevailing dogma.
Competing interests: No competing interests