H1N1: The Swine Flu Controversy

Every year an average of a fifth of a million Americans are hospitalized with influenza. Thirty-six thousand die. That number is a dramatic improvement over the number of lives lost in earlier generations: millions of lives were lost in the influenza epidemic following World War One, a medical disaster that destroyed even more lives than the war itself. Some infectious diseases such as polio have virtually vanished in the years since mass vaccination, but flu persists, and in seemingly ever-newer and more dangerous forms. One such strain is H1N1 (or the more commonly known ‘swine flu’). And while swine flu, like other forms of flu, can be to some degree contained, its symptoms moderated, its length shortened, and (say many doctors) its appearance even be prevented altogether if its potential targets are properly vaccinated beforehand, the drive to prevent swine flu has been preceded not only by waves of vaccination efforts but also by waves of controversy. Why?

Part of the reason is the ongoing controversy surrounding vaccination itself. Does vaccination safely prevent disease? Historically, there is little doubt as to its effectiveness. Applied widely, the diseases it targets have diminished to colossal degree. On the occasions when it has been discontinued, for reasons ranging from the religious to the economic, diseases that elsewhere went into vanishing decline began again to flourish. There is little doubt that, on the whole, vaccination works, and works extraordinarily well. The question is, does is work well in every case? Is it needed and cost-effective in every case? Or, as with antibiotic use contributing to stronger strains of diseases or the eradication of helpful strains of bacteria, are there unexpected negative consequences? Much of the swine flu controversy swirls not around issues with this particular strain, but with vaccination itself, and media and critics advocating alternative health approaches have been exceptionally adept in catching the public’s attention and focusing it on the general issue rather than this particular episode. But while concerns on both counts should certainly be brought up, wholesale panic is unmerited.

Why the controversy? The principal charges seem to be that mass vaccination is unnecessary; that immense profiteering is taking place by the pharmaceutical industries, who are working in collusion with politicians to push mass swine flu vaccination; that children are being targeted and experimented upon; that debatable new solutions are being added. How valid are these criticisms?

Is Swine Flu Vaccination Necessary?

The argument that people should not be vaccinated because some might never contract the illness is a weak one. Tens of thousands of deaths and hundreds of thousands of hospitalizations for influenza take place annually. Clearly it is a notable scourge. Does saving thousands, or even hundreds of thousands, justify inconveniencing millions? That is a social decision, but before being made it should also take into account the inconvenience caused and endured by those who are not hospitalized or pass away: infections have multiple and ripple effects, and as such need to be taken into consideration as well.

While roughly one percent of children are hospitalized with a severe infection each year, between ten and forty percent are infected annually with more moderate but nonetheless uncomfortable effects, that adds stress to parents and families, and that can provide a major host capable of spreading further infection to the rest of society. Including members of society that are less capable of enduring it: the majority of the thirty-six thousand seasonal influenza deaths occurring annually are visited upon the elderly. If mass swine flu vaccination saved only a few hundred lives, we might argue that a few hundred lives are nonetheless worth the effort; but it might easily save far more than that, in terms of hospitalizations that do not result in death, in prolonged illness and impacting parents, families and caregivers who might be profitably occupied elsewhere.

The Children’s Crusade

Speaking of children, is it the case that children are being disproportionately targeted – even “experimented upon”? The disproportionate targeting charge is true: but then it is swine flu itself that is disproportionately targeting young people. To date more than seventy percent H1N1 cases in America have involved people under the age of twenty-four. The most highly hospitalized victims have been children under the age of four. Targeting the population segments at most risk would seem sensible rather than malicious, if one can speak of “experimental targeting” at all when one considers that more than half of the population of the United States is under twenty-four. The valid and valuable data likely to arise from the use of control groups and double-blind criteria simply do not operate at such scales.

Can Swine Flu Prevention Itself Cause Disease?

Certain myths must immediately be dismissed. Do influenza vaccines cause flu? No. Vaccination does sometimes involve injecting disease-causing bacteria into individuals – dead disease-causing bacteria, or else material so desiccated as to make it impossible to cause the disease that the vaccination is intended to guard against. This is why adjuvants are often added. Adjuvants are substances added as part of a vaccine to cause immune systems to notice and react to antigens so weak that they fail to produce a sufficient response on their own. Sometimes this is because such a small amount of antigen is used, compared to what occurs during an infection, that the immune system simply finds it invisible. Adjuvants are needed to boost immune response from virtually zero to just enough to stimulate an immunity-producing reaction. Vaccines are intended to galvanize the immune system into being better prepared to reject disease; injecting highly virulent strains of disease-causing materials into individuals is not an advisable way to do so, and hence it is not done. There are simply no known cases of vaccination producing outbreaks of the disease they were intended to prevent; quite the contrary. Can infection follow vaccination? Yes. Vaccination is not a foolproof shield, and other diseases, variant strains, and an eventual wearing-off of vaccination benefits can occur. Whenever tens if not hundreds of millions of people are given a treatment, it is statistically inevitable that some treatments will be less effective than others, that some people will show a greater or lesser response than others, and that some of those treated will at some future point show signs of illness. But is that sufficient to establish a causal link? No.

Can vaccination trigger the onset of other diseases or conditions – in particular, does the thimerosal most vaccines contain cause autism? Repeated studies have failed to confirm any such effect, and no study to date has established a causal link between swine flu vaccination in particular and autism. Have young people developed autism after being vaccinated? Yes. Have they developed autism without ever being vaccinated? Yes. If a causal link is there, again, it has yet to be credibly established.

Concerns about thimerosal are rather ironic in that thimerosal was originally intended as a way of preventing vaccines from being bacterially tainted. Multidose vaccines – thimerosal is not given in single-dose H1N1 vaccination in the U. S. – involve repeated injections with a needle, which can draw bacteria into the vial, which in turn can cause toxic shock and disease. Thimerosal, which prevents bacterial contamination of vaccines, is used to protect against such problems. The thimerosal scare is also linked to, or confused with, the mercury scare: thimerosal contains ethyl mercury, which is related to – but not the same thing as — methyl mercury, which, in food, can be harmful in food. But the levels used in vaccination are far too small to have a negative effect: a 1999 FDA review specifically focusing on children’s mercury exposure to thimerosal-containing vaccines concluded the amounts used were well within the guidelines even for methyl mercury, much less ethyl mercury. Other studies have added their voices to the chorus: a 2001 report by the Institute of Medicine observed that the notion that thimerosal exposure could result in developmental disorders “is not established and rests on incomplete and indirect information”, and a later report in 2004 recommended completely rejecting the hypothesis that thimerosal caused autism. Numerous other studies find no apparent link between thimerosal and developmental disorders.

Can vaccination cause Guillain-Barré syndrome? The appearance of the syndrome, a neuromuscular disorder that can lead to paralysis, served to halt a National Influenza Immunization Program (NIIP) immunization effort on December 16, 1776, when cases of Guillain-Barré syndrome occurred in vaccinated individuals after over 48,000,000 Americans, a little under twenty-two percent of the then-population, had been immunized. Subsequent analysis put any causal relation in deep question, however. In the cases in question, 1098 cases of Guillain-Barré syndrome were recorded, but while 532 cases did occur after vaccination, 543 occurred before vaccination. Whether people are vaccinated or not, about one to two cases of Guillain-Barré Syndrome appear per every hundred thousand people annually. One review claims there is an increased incidence of occurrences of the syndrome in one case per million vaccinations, but the CDC notes that most studies on modern influenza vaccines see no Guillain-Barré syndrome link with vaccination whatsoever.

The Squalene Scare

Two companies, Novartis and GlaxoSmithKline, have contracted to use an adjuvant in their swine flu vaccine. The adjuvant is called squalene, and it too has been criticized in some popular corners as a potentially dangerous foreign substance attacking the body. There’s only one problem with this characterization. It is already a component in your body: squalene is an oil molecule native to human physiology and present throughout the nervous system and the brain. Squalene is also found in olive oil – and is rich in antioxidant properties. Others criticize squalene on the grounds that, injected, it will stimulate the immune system to create antibodies to attack not merely the vaccine squalene adjuvant but also the squalene already present in the body, including the squalene vital to the health of your nervous system; indeed that veterans with Gulf War Syndrome received anthrax vaccines which an contained an unapproved squalene adjuvant called MF59 since linked to shattering autoimmune diseases suffered by Gulf War veterans.

The notion of a link between squalene and autoimmune disorders stemmed from a 2000 article on Gulf War syndrome published in the journal, Experimental and Molecular Pathology. Researchers found that of thirty-eight subjects showing signs of Gulf War syndrome; ninety-five percent had squalene antibodies (“anti-squalene”) in their blood. Twelve veterans without symptoms of Gulf War syndrome, the researchers said, had no anti-squalene, and, and blame was placed on anthrax vaccines given to the soldiers prior to being deployed. However, since then, the U.S. military has revealed that the vaccines these soldiers received did not contain squalene at all – the vaccines involved alum, the only adjuvant then approved for use. Moreover, a post-2000 study, however, found no correlation between squalene antibodies and Gulf War Syndrome. And a subsequent study established that while anti-squalene antibodies are already present in a large percentage of adults, they are unchanged by subsequent exposure to squalene containing adjuvants.

Adjuvants containing squalene do not, in short, induce an immune response to squalene. Insurance studies confirm it: over forty million Europeans have had squalene-containing influenza vaccines as of 2009. How many subsequently serious adverse effects have been reported? 1.4 per 100,000 people; which virtually parallels the general population having no exposure to the vaccine. And the reason that a European study is cited is that squalene is only being used as an adjuvant in Europe. Those upset about the negative effect of its use in American should remember that Novartis and GlaxoSmithKline are not using it in America. In Europe, where they are using it, the negative impact is apparently nil.

Overall then, what is the level of risk involved in getting a swine flu vaccination? Very small. Newsweek’s FactCheck page summarizes it well:

* “The vaccine does have some risks – the same risks as the seasonal flu vaccine. Except for the virus, it is functionally identical to the vaccine that’s given every year.”
* “The multidose formulation of the vaccine contains thimerosal, which prevents contamination. Some have accused thimerosal of causing developmental disorders in children, but scientific evidence doesn’t support this.”
* “The vaccine does not contain squalene, which has been accused – also without good evidence – of causing Gulf War syndrome.”
* “There’s no reason to believe that a vaccination would cause Guillain-Barré syndrome.”

Legitimate Concerns

Are there valid concerns to be raised about the swine flu and vaccination? In fact there are. The risks of using H1N1 vaccine are as great as the risks of the seasonal flu vaccines, which are detailed on the Department of Health and Human Services website, flu.gov. As great, but no greater. As with the seasonal flu vaccine, side effects may occur, from allergic reactions to redness around the place of injection. Those hypersensitive or allergic to egg protein may be advised to reconsider, given that it is grown in eggs. Pregnant women may safely receive an injection, containing dead viruses, but perhaps not the nasal spray, which contains weakened but nonetheless live viruses. Those who have contracted Guillain-Barré syndrome within six weeks of a vaccination may be advised not to take the vaccine. Indeed, those who suffer panic attacks at the very thought of vaccination may choose to skip it for that reason alone. Vaccination, except in the cases of certain health workers, is not mandatory, and statistically speaking, most people who are not vaccinated for a disease do not in most cases contract the disease. That said, the more widespread the disease, the greater the odds of contracting same, and where societies as a whole have shunned vaccination, the results have proved to be devastating. But the odds still predict that most unvaccinated individuals will evade the illness in question.

Genuinely serious debate is also not inappropriate in those cases where social rather than medical issues are involved. Vaccinating millions of individuals at a cost of billions of dollars is a huge and expensive undertaking. Might the time and money be better spent addressing other health problems, or given over to research? At a time when diseases such as AIDS are devastating entire nations in Africa, or financial stress in difficult economic times is adding to the health burden to virtually every American, might the resources directed to a major vaccination effort be directed elsewhere? Such discussion is outside the scope of this article, but the subject is a significant one. Another concern is the financial involvement between the government and the pharmaceutical industry. There is no question but that vast sums are trading hands, and a great deal of public relations efforts and political lobbying has taken place. Is the H1N1 situation being engineered by major industrial complexes more to extract maximum profit rather than to prevent human suffering? Again, a legitimate subject to explore.

But such questions are social questions. From a medical standpoint, is controversy over H1N1 merited appropriate? Not really. The H1N1 vaccine is all but indistinguishable from the standard seasonal flu shot normally administered. It presents the same level of medical risk – very little to virtually none.

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