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A Defense of Childhood Influenza Vaccination and Squalene-Containing Adjuvants; Joseph Mercola’s “Dirty Little Secret”

Fall is around the corner, and with it comes the influenza season.  Each year an average of 200,000 people in the US are hospitalized with influenza, and 36,000 die.1,2 With the addition of the novel H1N1 strain (swine flu), this season promises to be more interesting, and even less predictable, than most.  There can be no doubt, however, that this one set of viruses will exact a heavy toll for thousands of families this season.

Too often in medicine we find ourselves confronted with problems we cannot fix.  Some traumas are too severe, some infections have too much of a head start.  Some diseases are poorly understood, while others have no known treatment.  One of the darker adages of medicine still holds true: In spite of all our advances, the world mortality rate seems to be holding quite steady at 100%.

Thankfully, influenza is not a disease against which we are helpless. We have ways to limit its spread, and medicines with a modest effect in assuaging symptoms and shortening the length of illness.  Most importantly, we have vaccines that can safely prevent the disease altogether.

There are myriad misconceptions and fears surrounding the influenza and its vaccines, most are not new and have been addressed elsewhere, including the concern that the influenza vaccines cause the flu (they don’t), that the thimerosal they contain causes autism (it doesn’t), and that it can trigger Guillan Barre Syndrome (it can3, at a rate of 1/1,000,000, similar to the background rate of Guillan Barre in the population4).  The confusion has been compounded by the emergence of the novel H1N1 pandemic.  With so much at stake, it is exceedingly important to have clear, accurate information available to physicians and the public alike.

Dr. Joseph Mercola’s recent screed foisted upon the public is no such source.  “Squalene: The Swine Flu Vaccine’s Dirty Little Secret” reveals his exceptionally poor grasp of the immune system, asserts that influenza is not worth preventing (36,000 deaths, 200,000 hospitalizations from seasonal flu, I suppose one could see his point), and perpetuates the thoroughly refuted toxin gambit. Nevertheless, at the time of this writing his article has misinformed nearly 250,000 readers.

If Thousands of Children Aren’t Dying It Can’t Be That Bad

His article begins with his confession that he doesn’t understand why children should be vaccinated against influenza.  After all, in his own words:

Less than 100 children in the US die each year from seasonal flu viruses… If children are the first target group in the U.S. per Sebelius, that means we’re about to inject around 75 million children with a fast tracked vaccine containing novel adjuvants, including dangerous squalene, to prevent perhaps 100 deaths.

First off, the groups given the highest priority by the CDC and HHS as outlined by Kathleen Sebelius for H1N1 vaccination are:

  • Pregnant women
  • Health care and emergency workers
  • Caregivers and close contacts of children under 6 months of age
  • Anyone between the ages of 6 months and 24 years old
  • Adults with a subset of chronic medical conditions

These groups differ from the seasonal influenza recommendations due to the behavior of H1N1 since its emergence.   Thus far, more than 70% of US H1N1 cases have been in people under the age of 24, and children less than 4 years of age have had the highest rate of hospitalization.  The recommendations are designed to protect those at the highest risk of complications and death, and given that the groups targeted encompass more than half the US population (approx. 159 million people), children are hardly being singled out for experimentation as he implies.

Second, in discussing only the children who die, Dr. Mercola implies that the only benefit of vaccination is the prevention of death in the person vaccinated.  People aren’t either healthy or dead.  Those who survive an infection are still subject to its inherent suffering and complications.  Furthermore, survivors run a high risk of spreading it to others who then share in the risk and misery.  Dr. Mercola doesn’t seem to appreciate that children suffer the greatest rate of infection from seasonal flu each season (10-40% of all children are infected each year, ~1% of all infected children are hospitalized), and are therefore the primary source from which influenza spreads (that’s the “infectious” part of an infectious disease, I know, it’s subtle) to the rest of the population.  By immunizing children against influenza we not only save their lives, we also reduce the burden of disease on the elderly who make up the bulk of the 36,000 seasonal influenza deaths each year.  We do not vaccinate “to prevent perhaps 100 deaths,” we vaccinate to prevent a disease altogether, and to help the entire population avoid all of these risks.

Preventing children from contracting influenza, either seasonal or H1N1, is a very rational, humane goal, and hardly the “ridiculous assumption” Dr. Mercola claims it to be.

Fear Factor: Squalene Edition

After his incredibly callous argument to allow children to contract influenza (I’m paraphrasing for brevity), Dr. Mercola then employs the toxin gambit to assert that the H1N1 vaccine is unsafe.  Here I have to give him credit for promoting yet another molecule to the anti-vaccination list of Chemicals of Omnipotent Toxicity™: Squalene.

The U.S. government has contracts with several drug companies to develop and produce swine flu vaccines. At least two of those companies, Novartis and GlaxoSmithKline, are using an adjuvant in their H1N1 vaccine.

Half-truths are the most dangerous ones aren’t they? Novartis and GSK are indeed developing H1N1 flu vaccines with adjuvants containing squalene.  In fact, they’ve been doing it for more than a decade – but I don’t want to give away the punch line.  Let’s examine the rest of Dr. Mercola’s claims first.

Adjuvants cause your immune system to overreact to the introduction of the organism you’re being vaccinated against.

No.  Adjuvants are used to get your immune system to recognize and react to antigens that do not trigger a sufficient response on their own.  Sometimes this is because the antigens are poorly reactive without being attached to a virus or bacteria like they usually are.  Other times it is because we use such a minuscule amount of antigen compared to what occurs during an infection that it’s invisible to the immune system.  For example, vaccination against Hepatitis B exposes you to a total 30 mcg of antigen compared to 1100 mcg/hour produced during an infection6.  Regardless, adjuvants take your immune response from next to nothing to just enough to induce immunity.

Less vaccine required per person means more individual doses available for mass vaccination campaigns. Coincidentally, this is exactly the goal of government and the pharmaceutical companies who stand to make millions from their vaccines.

Dr. Mercola’s on to us!  Maybe he saw the latest batch of H1N1 vaccine delivered in one of our unmarked black helicopters.  We should really be more careful.

It is no coincidence that we are trying to make hundreds of millions of vaccines at a limited cost.  It is fully intentional.  The world is faced with the need to produce hundreds of millions of doses of influenza vaccine with a limited amount of antigen and a limited amount of time.  Failure to meet the demand will result in rationing of vaccine supplies and will leave people vulnerable who desire and deserve to be protected.  Again, we would have needless suffering and lives lost.  If the use of an adjuvant can help meet this demand, reduce costs, and save lives, then yes, it should be strongly considered.

Before I leave this comment, I’ll take the opportunity to point out that pharmaceutical companies, doctors, and hospitals stand to make a lot more money from an uncontrolled pandemic than from its prevention.  The money spent on antivirals, antibiotics, sedation and pain medications, physician and hospital billing for the 200,000 people hospitalized in the US during a normal flu season would compensate them far better than profits from vaccine sales. It’s almost as though, against our financial interest, all of our efforts are designed to keep people from getting sick…

Your immune system recognizes squalene as an oil molecule native to your body. It is found throughout your nervous system and brain. In fact, you can consume squalene in olive oil and not only will your immune system recognize it, you will also reap the benefits of its antioxidant properties.

The difference between “good” and “bad” squalene is the route by which it enters your body. Injection is an abnormal route of entry which incites your immune system to attack all the squalene in your body, not just the vaccine adjuvant.

Your immune system will attempt to destroy the molecule wherever it finds it, including in places where it occurs naturally, and where it is vital to the health of your nervous system.

Gulf War veterans with Gulf War Syndrome (GWS) received anthrax vaccines which contained squalene. MF59 (the Novartis squalene adjuvant) was an unapproved ingredient in experimental anthrax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets.

There are several points that could be addressed in this section, including anti-oxidant abuse, the childish (and incorrect) description of “good” and “bad” squalene, and the evidence refuting the claim anthrax vaccine given to Gulf War vets contained squalene, much less that it is the cause of Gulf War Syndrome (GWS).  However, the main claim Dr. Mercola makes here is that squalene, when injected, will trigger an immunologic response and that these squalene-specific antibodies will then cause untold havoc in your body.  That’s a testable hypothesis, and don’t you know scientists just love to test hypotheses?

To support his assertion he cites a small cohort study from 2000 that reported anti-squalene antibodies in veterans afflicted by GWS.  Case closed, right?  Not so much. A larger and better-designed study found no correlation between the presence of squalene antibodies and symptoms of Gulf War Syndrome.  More important regarding vaccine safety, a subsequent study  using more sensitive and accurate methods than those used in the study by Asa established that anti-squalene antibodies are present in a large percentage of adults regardless of exposure to squalene from vaccines, and are unchanged by subsequent exposure to squalene containing adjuvants.

In other words, adjuvants containing squalene don’t induce an immune response to squalene.  No antibodies are created to cause whatever autoimmune phenomena Dr. Mercola cares to postulate, including GWS.  His hypothesis fails.

There is virtually no science to support the safety of vaccine injections on your long-term health or the health of your children. Follow-up studies last on average about two weeks, and look only for glaring injuries and illnesses.

This is simply untrue.  Post-licensure surveillance for vaccine safety is among the most extensive in medicine.  Squalene-containing vaccines are no exception.  As of 2009, over 40 million people have been given squalene containing influenza vaccines in Europe.  The incidence of serious adverse events so far reported, 1.4/100,000 doses administered, is at the baseline of the general population with no exposure to the vaccine.

As far as long-term follow-up, squalene has been studied as part of influenza vaccines in over 30 phase 1-4 trials, 13 of which had 4-6 month follow-up, and included over 14,000 people, and the current influenza vaccines in development are subject to clinical trials with a 6-12 month follow up schedule.

THE PUNCH LINE

With his article Dr. Mercola sought to scare people away from vaccinating against influenza in general, and H1N1 in particular.  Contrary to Dr. Mercola’s poorly informed assertions, cherry picked and outdated studies, and outright misinformation, influenza is a real threat and vaccines against it are both effective and safe.

Ah, but earlier I promised you a punch line. Remember this quote?

The U.S. government has contracts with several drug companies to develop and produce swine flu vaccines. At least two of those companies, Novartis and GlaxoSmithKline, are using an adjuvant in their H1N1 vaccine.

Novartis and GSK are indeed developing influenza vaccines containing adjuvants – for use in Europe, where squalene containing adjuvants have been safely used for over a decade.  The US is indeed conducting H1N1 vaccine safety and efficacy studies that include the use of adjuvants.  Given the unpredictable nature of the upcoming season and the very real potential that vaccine demand will outstrip its supply, it would be irresponsible for the US not to be prepared with a well studied contingency plan that includes possible adjuvant use.

However, it must be clearly stated that there are no adjuvants, nor have there ever been, in the US influenza vaccines.  Furthermore, barring the highly unlikely failure of the standard unadjuvanted vaccines currently in trial, the H1N1 vaccines available in the US will also be adjuvant free.7

Even if Dr. Mercola’s entire article made a single valid point regarding the use of adjuvants in the H1N1 vaccine, it is irrelevant to the US population.  Based on poor science, packed with misinformation, and designed to promote unwarranted fear, his article is not a source of information, it is dangerous, irresponsible fear mongering.

Citations:

  1. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA 2003;289:179–86.
  2. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004;292:1333–40.
  3. Guarino M, Casmiro M, D’Alessandro R. Campylobacter jejuni infection and Guillain-Barre syndrome: a case-control study. Emilia-Romagna Study Group on Clinical and Epidemiological problems in neurology. Neuroepidemiology 1998;17:296–302.
  4. Haber P, DeStefano F, Angulo FJ, et al. Guillain-Barre syndrome following influenza vaccination. JAMA 2004;292:2478–81.
  5. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA 2004 Sep 15;292(11):1333-40.
  6. Courtesy of Quackcast, Episode 30, 2/22/2009, by Mark Crislip. http://www.quackcast.com/spodcasts/files/48f9db861d8a83f764792aa4b77990f8-29.html
  7. This decision drew heat from the international medical community, as it runs counter to the World Health Organization’s recommendations, will mean fewer vaccine doses produced overall, and may compromise our ability to control the spread of H1N1 worldwide if supplies fall short.

Posted in: Public Health, Vaccines

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