The flu vaccine: Is the proof in the pudding?

UnknownThe first crisp mornings of the year, the return of the pigskin, and the sweeping color changes found throughout the landscape—I love fall.  Fall is a welcome change after the long heat of Summer.  Fall brings many things, some good and some bad.  Just as fall moves us past the summer heat, fall also ushers in the cold weather and the dreaded cold and flu season.

 

The statements about the flu season are as prevalent as the virus itself: the flu vaccine is “as good as gold, the “proof is in the pudding”, and “protect with the flu vaccine”.   I recently saw an ad campaign for the flu vaccine state: “the value of wellness”, implying that the flu vaccine equaled wellness.   I even heard a medical report, by a physician no less, on the radio say “its better than nothing”.

 

So, I got to thinking—with the cold and flu season upon us, does the scientific data support the flu vaccine.  Not, what does the collective think.  Not, what does marketing based-medicine say, but what does the evidence show.  What is the best way to protect my and your family during this cold and flu season?  How can one treat and even prevent the flu this upcoming season.  Is it as good as gold?  Is it better than nothing?  Is the flu vaccine the value of wellness? Is the flu vaccine the proof that is in the pudding?  No opinions, just evidence.

 

 

Today is suppose to be the era of evidence-based medicine.  So, what does the evidence show?  Let’s hold medicine up to the standard of the evidence, not stoop down to the “its better than nothing”.

 

Good evidence doesn’t need a spokesman.  Good evidence and truth will speak for itself.  Science is not politics.  “Spin” has no place in science.  A lot of what occurs with medical publications today is paramount to political spin.   No truth, just make the truth what you want it to be.  Truth is manipulated to drive an agenda.

 

Is The flu vaccine as good as gold?

 

The answer according to the available, published evidence is NO.  Don’t take my word for it, let the evidence speak for itself.

 

A Cochrane Review analysis, “Vaccines for preventing influenza in healthy adults”, published in 2010 looked at over 70,000 adults in 50 studies ages 16-65 from 1966 to 2010.  The objective was defined as: “identify, retrieve and assess all studies evaluating the effects of vaccines against influenza in healthy adults”.  The results may surprise you:

  • Flu vaccine was found to be a very poor match (1%).  Each year, the 3-strain flu vaccine is created in attempt to match the up coming viral strains.  One percent match of 200+ influenza virus’ is very poor.
  • Flu vaccine only had a modest effect on reducing flu symptoms and days missed
  • The flu vaccine only prevented 1.5 cases per 100 people vaccinated
  • No evidence was found that the flu vaccine affects complications.  Complications were defined as pneumonia, hospitalization, and TRANSMISSION.

 

Take home from the 2010 review:  if you are a healthy adult, the flu vaccine is a waste of your time.

 

What is the Cochrane Review?  The Cochrane Review is an independent investigation into the “original studies” on a given subject to provide “systematic reviews of primary research in human health care…” for the purpose of evidence-based application of the science.  Medicine is the clinical application of biochemistry as found in the science.  Essentially, the Cochrane Review is an attempt to rise above the political, biased approach of marketing-based medicine and return to the roots of evidence-based medicine.

 

Want more evidence?  Not a problem.

 

A 2004 Cochrane Review looked at 25 studies from 1966-2003 that involved 59,566 people ages 14 to 60.  The flu vaccine was found to have a low efficacy against clinical flu.  Efficacy is defined as “does the vaccine work”.  Efficacy is important in this discussion.  Overall, those vaccinated had a 6% reduction in the clinical flu.  The flu vaccine is all about flu prevention.  Unfortunately, the review only found an effectiveness (see definition below) of 15-25% against the clinical flu.  The conclusion is no surprise: “Universal immunization of healthy adults is not supported…”.

 

A 2007 Cochrane Review looked at 48 studies from 1966-2006 that involved 66,248 people ages 16 to 65.  This study found an 80% efficacy rate (see definition above) against the flu if “the vaccine matched the circulating strain AND the strain was high”.  A few “ifs” involved here.  The problem is that this efficacy rate dropped to 50% if the match wasn’t perfect and the circulating strains chosen were not high.  That is a 50:50 shot at best.  Flip a coin.  In that case, I guess it is better than nothing.  But, when one looks at the last 10 year effectiveness rates, according to the CDC (see data below), that 50% drops to 20% based on the “if” of perfect strain match alone.  With this additional data, nothing probably is better than the flu vaccine especially when the placebo effect normally exceeds 20%.

 

How about a more recent analysis?  A 2014 Cochrane Review looked at 116 studies that involved > 8 million people, including pregnant women.  The poor results continued in the 2014 review.  According to the 2014 analysis, 71 people need vaccination for 1 case of flu prevention.  No effects were see on decreased hospitalization and prevention of work days lost.  The results for influenza-like illnesses had a little better results at 1 influenza-like illness prevention for every 40 people vaccinated.  However, of all the studies evaluated in this analysis, less than 10% had “good methodological quality”.  Translated, only 10% of the studies evaluated can be relied on as good evidence to support the 1 in 71 or 1 in 40 prevention.  From this 10% comes the modest to poor results in the 2014 Cochrane Review.  The authors conclusion says it all: “The results of this review provide no evidence for the utilization of vaccination against influenza in healthy adults as a routine public health measure.”

 

What about our children?  One of the biggest populations pushed for the flu vaccine seems to be children.  A 2012 Cochrane Review looked at 75 studies from 1966-2011 in children under the age of 16.  In contrast to the wide spread reports of efficacy and safety in children, the 2012 study could find “no usable data” for children under the age of 2.  Translated, no good, reliable data exists for the flu vaccine in children under the age of 2.   Of those children > 6,  28 children need vaccination to prevent 1 case of the flu versus 8 children for 1 prevention for influenza-like illness.  The significantly higher prevention of the influenza-like illnesses compared to confirmed influenza completely calls into question the effectiveness of the flu vaccine because the flu vaccine has better results for influenza-like illnesses (of which many are likely non-influenza) compared to influenza for which the flu vaccine is specifically targeted.  The authors cast serious doubt on the conclusions of the studies included in the analysis due to the biased nature of the studies and thus the undue influence on the published results:

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

 

Historically, effectiveness of the flu vaccine is very poor at best.  Effectiveness is defined as “does the vaccine help people”.  Here are the effectiveness numbers of the flu vaccine from 2004-2015 according to the Centers for Disease Control (CDC):

2004-2005—Effectiveness of 10%

2005-2006—Effectiveness of 21%

2006-2007—Effectiveness of 52%

2007-2008—Effectiveness of 37%

2009-2010—Effectiveness of 56%

2010-2011—Effectiveness of 60%

2011-2012—Effectiveness of 47%

2012-2013—Effectiveness of 49%

2013-2014—Effectiveness of 51%

2014-2015—Effectiveness of 23%

 

That is a 10 year average of 40.6%, and that is the average.  Some of the match years were as low as 21%!  Other countries seemed to have faired much worse.  The effectiveness of the flu vaccine last year in the UK was 3%!  I am not sure to many things that people will pursue with that kind of effectiveness?  Follow the logic: your flight has a 40.6% chance of being good for you.  Your financial investment has a 40.6% chance of being good for you.  That surgery will have a 40.6% chance of being good for you.  Get the picture?

 

Is the proof in the pudding?  The answer to that question depends on what efficacy and effectiveness rates are acceptable to you.  But for me, a practitioner of evidence-based medicine, the proof in the pudding is that the flu vaccine is not acceptable in efficacy or effectiveness.

 

Don’t worry, there are many scientifically proven preventative and therapeutic treatments available to attack the flu.  The problem is they are labeled “natural” or “alternative” and so you and/or your doctor may not have heard of their benefits.  But it turns out these therapies are the proof that is in the pudding for flu prevention and treatment.   The next blog post will present these therapies and the proof in their pudding.

addendum (2.27.16):

 

The CDC now estimates that the 2015/2016 flu vaccine was 59% effective.  The CDC headline, “Flu vaccine nearly 60% effective” is telling of the failure.  We are all guilty of using this verbal manipulation:  we nearly won the game; I nearly passed the test.  The word nearly is used to provide comfort in the face of failure.  Words have meanings.  Words are not simply present to occupy space on a page.  The fact that a failing grade is paraded around as a giant success is disturbing.  The fact that an “estimate” is paraded is even more disturbing.  We in the medicine, scientific field should demand more!  Patients should demand more!  Since when did we accept failure as a success?  Since when did we allow estimates to become the standard in the assessment of effectiveness?  Not once since the CDC has kept records of the “estimated effectiveness” of the flu vaccine has it achieved a passing grade.  Yet, success is proclaimed from the mountain tops; the confetti is triggered; all for 59%.

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Comments

4 Responses to “The flu vaccine: Is the proof in the pudding?”
  1. But even if the vaccine isn’t extremely effective, over millions of vaccinations, it ends up being worth it, doesn’t it? If 100 million people get the vaccine of them and 10% of them are helped by it, that’s 10 million people that didn’t get sick thanks to the vaccine. Even though 10% effectiveness is low, that’s still a pretty good end result, isn’t it?

    I’d understand if the flu shot were extremely expensive or something, but it’s not and is even free in a lot of places, so I don’t really see the harm in getting it. But maybe there’s something I’m missing…

    • seasonswellness says:

      Compare that to the placebo rate most studies find in the range of 30-35%. We should strive for 100%, not 10%. Why would we inject anything to our patients, who trust us and believe the flu vaccine to be highly effective, that has an efficacy of 10%?

  2. Rachel P says:

    I’ve never gotten a flu shot (nor will I ever) and I’ve never gotten the flu. We need to build up our immune systems, not inject toxic psuedo-immunity into our bodies. Thank you for this post, Dr. Goodyear!

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