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t’s an edict that comes out every autumn in many hospitals: If health care workers don’t get a flu shot, they will face consequences. Some make vaccinations a condition of employment. Others require unvaccinated staff to wear surgical masks near patients for weeks during flu season.

But a new study is calling into question the scientific evidence underpinning these increasingly common hospital policies — and could fuel challenges to the contentious orders.

The study, published Friday in PLOS One, concludes that the research used to justify mandatory flu shots for health sector workers is flawed, and that the policies cannot plausibly produce the benefits that had widely been assumed.

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That is not to say that the group of epidemiologists from Canada, Australia, and France behind the new research opposes the flu vaccine.

“I take it myself,” lead author Dr. Gaston De Serres said. “The reason why I do that is I continue to have the impression that it could work. But it’s one thing to say: ‘OK, on a voluntary basis, you get the vaccine despite all its weaknesses,’ and it’s another thing to say, ‘If you don’t get it, you get fired.’”

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Mandatory flu shot policies vary across hospitals and geographic jurisdictions. In some cases, staff who have refused vaccinations have been fired.

Dr. Melanie Swift, an associate professor of clinical medicine at Vanderbilt University and director of its occupational health clinic, said a policy that went into effect there last year results in health workers who refuse the vaccine being sent home without pay.

Faculty — in most cases the doctors — who refuse flu shots are locked out of the university’s information systems. They can’t enter information into patients’ charts, can’t do research, can’t bill for their time. “It’s pretty significant,” Swift said.

Swift gets a flu shot and recommends them to others. And she supports mandatory vaccination policies for some conditions, if there’s clear evidence that unvaccinated health workers pose a risk to patients. She does not support such a policy for influenza vaccine, however. “The case is not there for flu,” she said.

Some policies and firings have been challenged in front of labor tribunals or courts. In those cases, employers regularly point to four specific studies to bolster the argument that vaccinating health care workers reduces the risk of vulnerable patients contracting influenza from caregivers.

But the methodology of the studies produced results that don’t stand up to scrutiny, the authors of the new paper said.

None of the studies were conducted in hospitals; all took place in long-term care facilities. One the studies, from Britain, calculated that one influenza death would be averted for every eight staff members vaccinated.

But if that were correct, vaccinating the estimated 1.7 million health care workers employed in long-term care in the United States should prevent 212,500 flu deaths a year among residents. There’s an obvious problem though, the paper noted. Nowhere near that many people die from flu in the US.

The Centers for Disease Control and Prevention estimates there are between 3,000 and 49,000 flu deaths a year in this country, including people of all ages. The death toll varies depending on which strain of flu is causing the most illness and how well-matched the strains in the vaccine are to the viruses making people sick.

If the calculation is applied to the 5.5 million hospital workers, mandatory flu shots should avert 687,500 deaths each year — more than the number of Americans who died in the 1918 Spanish flu, estimated to be 675,000. The Spanish flu was the worst influenza pandemic in known history.

“The study today does not refute that vaccination could have some impact on reducing transmission from infected health care workers to patients. But it clearly shows there’s no well-conducted study that demonstrates that at this time. Our public policy should be guided as such,” said Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy, and lead author of a comprehensive report on influenza vaccine.

De Serres, of the Quebec Public Health Institute in Quebec City, said policies on vaccinating health care workers have evolved over the years, from a gut feeling that it would likely do some good to the idea it should and could be demanded of health workers.

“Do we have scientific data supporting that? I think the bottom line of our paper is to say there is no valid scientific evidence, even now, underpinning enforced health care worker immunizations,” De Serres told STAT.

The lead author of the British study that concluded eight vaccinated health workers would avert one flu death defended the work in a commentary the journal published with De Serres’s article.

Andrew Hayward, of University College London’s Institute of Epidemiology and Health Care, argued among other things that the seniors his group studied were getting 24-hour care. In other words, they were the frailest of the frail elderly.

“While we claimed that the findings may be generalizable to other settings we did not intend to imply that the extent of the benefit would be similar in other settings. Indeed we think the effect is likely to be substantially greater in long-term care facilities for frail elderly residents than in the acute care setting or in long-term care facilities catering for less frail patients,” Hayward wrote.

Paradoxically, the influenza research community has been down a road much like this one before.

Around the turn of the century, studies assessing the impact of vaccination used to routinely estimate that flu shots cut deaths among the elderly during flu season by a whopping 50 percent.

Not flu deaths. All deaths.

It was dogma for a long while. In fact, it was so entrenched that even questioning how preventing influenza could reduce deaths due to other causes was considered heretical. Dr. Lisa Jackson, a senior investigator in immunization studies at Seattle’s Group Health Research Institute, was one of the leading heretics.

She remembers well receiving a 12-page screed from a reviewer when she and others tried to publish their challenge in the Journal of the American Medical Association. Their ideas were likened to declaring the Earth was flat; they were warned thousands of deaths would be on their heads if their paper was published and believed.

The article was published in 2006 and she and her coauthors eventually persuaded the flu world that flu vaccine could not have such a big effect. Now she’s occasionally asked why she had to bother writing the 2006 paper; the findings it debunked, in 2016, seem so clearly flawed.

Jackson agreed with the argument made in this new paper. “We can’t say what the benefit [of vaccinating health workers] is,” said Jackson, who was not among the authors. “All you can say is these other studies are a gross overestimation.”

Swift said the fights over forcing health care workers to be vaccinated are also drawing needed attention from the pressing issue about flu vaccine. “All this is trying to mandate that health care workers take the flu vaccine is well-intentioned, but is taking away resources and the focus on what our main priority needs to be, which is getting a better influenza vaccine.”

  • This study is vindication to all healthcare workers who have had their rights violated for political intentions and pharma profits masquerading as science and protection of public health. We have known for years the studies to support these programs were bunk, Thank God for the courage of these researchers to come out against this giant sized lie.

  • As healthcare workers we aspire to evidence based practices. Meanwhile, the shockingly inadequate evidence to support healthcare worker influenza recommendations was dismissed by policy makers and largely never investigated by the majority of doctors and nurses.
    This speaks to a very concerning problem- consensus science, idealism and the derogatory insults of so called “experts” in the press allows a masking policy that threatens therapeutic patient relationships/risks medical error/alienates challenged patients and demoralizes staff
    ….I ask you..do you want health care professionals who simply do as they are told? and never investigate quality evidence or challenge the agendas of hospital administrators ?

  • · A 2007 Lancet study found: “Recent excess mortality studies were unable to confirm a decline in influenza related mortality (flu deaths) since 1980, even as vaccination coverage increased from 15% to 65%.”[i]
    · A 2008 Lancet study reported that the flu shot did not reduce risk of pneumonia in the elderly.[ii]
    · During the 2009-2010 swine flu pandemic, the AMA and the CDC endorsed non-mandatory flu vaccine
    policies,[iii] suggesting no need for mandates outside of a pandemic.
    · A 2010 review of the flu vaccine literature for healthy adults by the Cochrane Collaboration, an independent, international consortium of medical researchers, issued a “WARNING” stating that “reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions…” The review also found that “vaccine use did not affect . . . working days lost” and “had no effect on hospital admissions or complication rates.”[iv]
    · A 2010 Cochrane review of all existing literature on the effectiveness of flu vaccine campaigns in the
    elderly showed that “the available evidence is of poor quality and provides no guidance regarding the safety,
    efficacy, or effectiveness of influenza vaccines for people aged 65 or older.”[v]
    · A 2011 Occupational Safety and Health administration (OSHA) Position Statement said it “believes there is insufficient scientific evidence for the federal government to promote mandatory influenza vaccination programs that do not have an option for the HCP [healthcare professionals] to decline for medical, religious and/or per­sonal philosophical reasons.”[vi]
    · A 2011 Lancet study revealed that flu vaccines
    are 60% effective. However, the 60% figure was the “relative risk reduction” (rounded up); the “actual risk reduction” was a trivial 1.5%.[vii]
    · A 2012 Lancet study stated: “There are no randomized controlled trials showing efficacy of TIV (the inactive flu virus) in people aged 2-17 years or adults aged 65 and older. For LAIV (the live flu virus), there are no randomized controlled trials showing efficacy in people aged 8-59.[viii]
    · A 2012 critical review in The International Journal of
    Family Medicine concluded: “The arguments for uniform healthcare worker influenza vaccination are not supported by existing literature. The decision
    whether to get vaccinated should, except possibly in extreme situations, be that of the individual healthcare worker, without legal, institutional, or peer coercion.”[ix]
    · A 2013 BMJ article documented that public health authorities’ aggressive promotion of the influenza vaccine is not supported by the medical literature and fails to acknowledge serious vaccine risks. E.g., contrary to wildly mistaken claims, only 16% of tested respiratory specimens are positive for influenza, and
    serious vaccine adverse events are well documented internationally.[x]
    · In 2013, the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota reported on studies showing that the influenza vaccine provided “little or no protection” in 2010-11, and that getting a flu shot 2 years in a row may actually lower protection.[xi]
    · A 2014 “Systematic Review of Mandatory Influenza Vaccination in Healthcare Personnel” in the America Journal of Preventive Medicine concluded that “evidence on clinical outcomes is lacking.”[xii]
    · A 2014 Pediatric Infectious Disease Journal study
    found that the trivalent influenza vaccine “was not observed to ameliorate symptoms or viral shedding among vaccine failures (infections occurring among
    vaccinated persons) compared with infected placebo recipients.”[xiii]
    · A 2014 Cochrane Summary found that influenza vaccination “shows no appreciable effect on working days lost or hospitalization.”[xiv]
    [i] Simonson, et al (2007). Lancet Infect Dis 7: 658-66
    [ii] Lancet. 2008 Aug 2;372(9636):398-405.
    doi: 10.1016/S0140-6736(08)61160-5.
    [iii] AMA meeting: No flu shot mandate for doctors; hand sanitizer pushed, http://www.ama-assn.org/amedne… Vaccine News and Commentary from the University of Pennsylvania Centers for Bioethics,http://blog.vaccineethics.org/…, citing 75 Fed. Reg.
    35497 (June 10, 2010).
    [iv] Vaccines for preventing influenza in healthy adults, http://www2.cochrane.org/revie….
    [v] Jefferson, T. et al (2010). Cochrane Database of Systematic Reviews. 8: Article #CDOO4879
    [vi] National Vaccine Advisory Committee Meeting Minutes, September 13-14, 2011, APPENDIX B: OSHA
    Position Statement, as submitted by Mr. Borwegen, representative of the Service Employees International Union, http://www.nvic.org/CMSPages/G…
    [vii] Flu Shots, Fosamax and Pharmaceutical Fakery: The Common Use of Misleading Statistics in the
    Medical Literature, Gary G. Kohls, M.D., Dec. 3, 2011, http://www.thepeoplesvoice.org….
    [viii] Osterholm, M. et al (2012). Lancet Infect Dis 12: 36-44
    [ix] What, in Fact, Is the Evidence That Vaccinating Healthcare Workers against Seasonal Influenza Protects Their Patients? A Critical Review, Int J Family Med. 2012; 2012: 205464, http://www.ncbi.nlm.nih.gov/pm…
    [x] BMJ 2013;346:f3037, http://www.beyondconformity.or…, May 16, 2013
    [xi] Study: Getting flu shot 2 years in a row may lower protection, CIDRAP, March 1, 2013, http://www.cidrap.umn.edu/cidr…
    [xii]
    http://www.ajpmonline.org/arti
    [xiii] Pediatr Infect Dis J. 2014 Feb;33(2):e63-6. doi: 10.1097/INF, http://www.ncbi.nlm.nih.gov/pu…
    [xiv] Demicheli V, Jefferson T, Al-Ansary LA,
    Ferroni E, Rivetti A, Di Pietrantonj C. Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews 2014, Issue 3. Art.
    No.: CD001269. DOI: 10.1002/14651858.CD001269.pub5 – See more at: http://summaries.cochrane.org/…

  • I have an issue with the concluding quote: “…what our main priority needs to be, which is getting a better influenza vaccine.”

    Given that the point of this article is that the mandate is unjustified (in fact, arguably “anti-scientific”), our “main priority” should be to figure out how it became a mandate, and how many other mandates, regulations and guidelines cause more harm than good.

    To discussants below, remember that some people die every year from the flu shot. If it doesn’t really work to prevent influenza (and makes flu-like illness more likely (see link below)), then it should be eliminated, not mandated. Sorry to the agencies holding vaccine stock. And let’s view all non-randomized studies with suspicion, going forward.

    https://www.ncbi.nlm.nih.gov/pubmed/22423139

    • I’m curious about your suggestion that “people die from the flu shot every year.” Try as I might, I can find no data to support that statement. Did you read the paper you linked to? It followed 115 kids- some had a placebo (presumably a shot of saline), and some had a flu vaccine. Many kids from both groups experienced illness over the ensuing months. Of those that had a flu vaccine, there was a slightly higher rate of kids with viral-borne illnesses- they detected Rhinoviruses (responsible for the common cold, and a variety of other nuisances), and two enteroviruses that produce two to three days worth of general malaise sometimes accompanied by a low fever. There were no flu-like illnesses reported. The study does not report whether the placebo group suffered more bacterial illnesses, which would be interesting to know. The sample size is small, and a follow-up study with a larger group would be necessary to determine whether the slight elevation of non-flu related viral infections in the vaccine group was real, or chance. It’s hard to extrapolate anything to a general population when you’re looking at 60 kids- three kids’ outcomes may determine whether your results are significant.

    • Can you give a reference for your suggestion that people die from taking the flu shot?
      There has been an update to the study you did cite, by Cowling et al, suggesting that kids who got vaccinated against flu had a higher rate of non-flu respiratory illnesses.
      Ben Cowling and his group did a longer term, much larger study looking at that issue and found no association, i.e. they refuted their earlier results. They presented the data last summer at the Options for the Control of Influenza conference; undoubtedly this is in the publication pipeline somewhere.
      You can see the abstract in the Options conference program, which is here: http://2016.isirv.org/sites/default/files/docs/2016/isirv-16-fp-web.pdf
      The abstract is number O-79.
      The conclusion is this:
      Conclusion: In this 3-year test-negative study in the United States, we did not find any evidence that receipt of influenza vaccination affected the risk of infection with another respiratory virus. Among patients testing negative for an influenza virus, we found no significant associations between detection of other respiratory viruses and receipt of influenza vaccination.

  • This is a great article providing yet further proof that mandatory vaccination programs for healthcare workers are based on erroneous science and pharmaceutical greed. This is a topic I have spent many hours researching–much of my research was summarized in an eBook on flu vaccines, the flu itself, and implications surrounding flu vaccine mandates for healthcare workers: http://amzn.to/2eXHIuT

  • Well we know what the real reason is for mandating the flu vaccine. It’s the money facilities stand to lose if over 90% of their workforce isn’t vaccinated. And that’s the only real reason.

    • The Depart of Justice issues a report on vaccine injuries and deaths every quarter to the Advisory Commission on Childhood Vaccines (Click on “Meeting Book – PDF – 12 MB” for June 4 meeting). There 163 cases for vaccine injuries and deaths for the period 2/16/2015 through 5/15/2015. 103 of the settlements were listed in this report, giving the name of the vaccines, the injury, and the amount of time the case was pending before settlement. Four of those settlements were for deaths linked to vaccines, with three deaths related to the flu shot, and one death for the Hepatitis B shot, typically given to newborns. 74 of the 103 settlements were for injuries and deaths due to the flu shot, and the majority of flu shot injuries were for Guillain-Barré Syndrome. These quarterly reports on vaccine injuries and death settlements from the U.S. vaccine court are seldom, if ever, reported in the mainstream media.

  • http://www.ncbi.nlm.nih.gov/pu…
    A double blind placebo study shows the flu vaccine to be highly ineffective. Those who were unvaccinated took one extra days off (2.5 days vs. 3.5 ) but the vaccine did not reduce respiratory infections. This is obviously dangerous as the vaccine although not reducing the respiratory symptoms, allowed people to stay at work and infect others.

    Of the 547 randomized vaccinees 427 (78%) persons completed the 4-month follow-up and returned the sickness logs. Immunization failed to reduce episodes of respiratory infections (1.8 episodes/study period among vaccinees vs. 2.0 among controls). Similarly the vaccine failed to affect the total number of days the vaccinees suffered from respiratory infections (13.5 days vs. 14.6 days, respectively).

  • So there are fewer (by a decimal place) deaths than expected….but at this time there is mandatory vaccination; so can it be inferred that the discrepancy is due to vaccination? Very likely. This is terribly flawed “science.”

    • Keep grasping Shulman
      Read the review. the flu vaccine doesnt work to protect as it claims. There is not a single facility who mandates influenza vaccination who can show the vaccine has had any clinical benefit ( Pitt et al. 2013) influenza deaths have not gone done despite influenza vaccination rising. It aint working, give it up.

  • Oh for gosh sakes! It’s a policy the hospital has decided to adopt. Businesses have all kinds of policies that employees are required to adopt as a condition of employment. Simply put vaccines in the employee manual and have HR explain the policy to applicants right up front. There is ample evidence that immunizations are protective to some degree. Among employees “herd immunity” will likely protect the few workers who have a medical reason for not getting vaccinated. A new study seems redundant and wasteful.

    • Herd immunity has never been supported by science. Perhaps we should research what was causing the end to epidemics and that would be sanitation, clean water, sewer systems that worked. In fact areas around the world that stopped vaccinations showed far less incidents of disease and death that the highly vaccinated, mandatory locations. Not to mention we are completely ignoring the science for the side effects from the vaccines so obviously we are missing a lot of data here.

    • Seriously, so we are supposed to ignore quality evidence and circumvent human rights based on a “hunch” there is not reliable evidence to illustrate the flu vaccine is protective to some degree. Read the Cochrane review on vaccination of adults…proof is not there, never has been.

  • Forcing people to take toxic vaccines which contain aluminium and in the multidose mercury is counterproductive. Most doctors and health workers reject them anyway.

    The Cochrane Collaboration, the world’s foremost group of unbiased researchers, physicians and scientists, has performed a series of meta-analyses on the effectiveness of the influenza vaccine. In 2014 they found that vaccinating adults against influenza did not affect the number of people hospitalized nor decrease lost work. Cochrane researchers stated that their results might be overly optimistic due to the fact that 24 out of 90 studies were funded by the vaccine manufacturers, which tend to produce results favorable to their product.

    According to Dr. Tom Jefferson at the Cochrane Collaboration, it makes little sense to keep vaccinating against seasonal influenza based on the evidence. Jefferson has also endorsed more cost-effective and scientifically-proven means of minimizing the transmission of flu, including regular hand washing and wearing masks. There is also substantial peer-reviewed literature supporting the supplementation of Vitamin D.

    Dr. Jefferson’s conclusions are backed by a 2013 article by Johns Hopkins University School of Medicine scientist Peter Doshi, PhD, in the British Journal of Medicine. In his article Doshi questions the flu vaccine paradigm stating:

    “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.”[20]

    http://www.globalresearch.ca/the-toxic-science-of-flu-vaccines/5554257

    • “Toxic” vaccine? What nonsense. There may be sensible reasons to change mandatory flu vaccine policies. But that’s not one of them. “Most doctors reject” the flu vaccine? Nope. Wrong again.

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