Will a flu shot keep you healthy?

By Alan Cassels, October 2012

The Cochrane Collaboration’s examination of flu vaccines in healthy adults, a body of literature spanning 25 studies and involving 59,566 people, finds an annual flu shot reduced overall clinical influenza by about six percent.

How many diseases are important enough to have their own season? Not many, but we do have one, and it strikes every year: the flu.

Arriving in the fall and exiting in the spring, flu season strikes with the predictability of clockwork. For some the flu might be a mild inconvenience, perhaps embraced as a way to stay home and get a few days couchside wrapped in the unpleasantness of high fever, aches, sniffles, and daytime reality TV. Yet for others, usually the elderly or those with compromised immune systems, the flu can be deadly. It can lead to hospitalizations, pneumonia, and sometimes death.

Victoria might be on an island but its residents are not immune to viruses. So we prepare, stockpiling flu vaccines and drugs, hectoring the public to get an annual flu shot and, with a new twist this season, giving an ultimatum to health workers: either get a flu shot or wear a mask while at work.

BC’s Provincial Health Officer Dr Perry Kendall is betting that our province’s health workers need such strong medicine to stop them passing on the flu to their patients, and he’s launched the most aggressive flu policy in Canada, one which could set the trend for the rest of the country.

But Dr Kendall and his public health colleagues around the world are facing an uphill struggle as their anti-flu policies and public health mandates are increasingly criticized because of the strong-armed ways they are being enforced. Add to this the growing cynicism around the fear-mongering of recent flu pandemics, and the overzealousness with which vaccines are promoted, and you have a recipe for a cynical public.

But of most concern is the determination by some respected international scientists and researchers that annual influenza campaigns are likely an utter waste of time and money.

Half the story

“Don’t be like me, and be taken for a fool.” That’s the advice that Dr Tom Jefferson offers when I ask him about his research around flu vaccines and flu drugs. He has spent over a decade examining and summarizing the evidence around one of the most stockpiled drugs in the world, oseltamavir (also know as Tamiflu), and tells me over the phone from his office in Rome: “I can only say that I have acted as an unpaid salesperson for Roche [the maker of antiviral drug Tamiflu] for the last ten years!”

Now a researcher with the Cochrane Collaboration, working on acute respiratory infections and vaccines, Jefferson essentially confirmed what I’d heard from other researchers: that much of the published research on all kinds of drugs and treatments found in peer-reviewed medical journals is incomplete. It only gives half the story.

In the case of Tamiflu, a drug that is supposed to prevent the spread and the severity of the flu, Jefferson and colleagues have proven that the drug’s published dataset delivers a biased and misleading picture of the drug because the company has only released a portion of it. If your job is to find, summarize and synthesize what is in the published literature—as it is for a meta-analyzer like Jefferson—incomplete data sets are a major problem. Over the past few years he and his colleagues have frequently asked Roche to release Tamiflu’s full data set, but so far the company offers up mostly “the dog ate my homework”-type of excuses for why they can’t cough it up.

The scourge of hidden data is not new in medical research, but this just adds to the sense of how shaky the global influenza apparatus might be. When the companies that study the drug stand to gain billions on how that research is presented, we have a problem. Jefferson has written that poor science, coupled with “media business, pharma business, pandemic business and unaccountable decision-making,” are making a mockery of global policies around the flu.

The problem starts with a semantic one, where “the flu” is equated to “influenza,” a falsity which Jefferson writes “is now so ingrained in the popular and sometimes professional mind that governments and public fall prey to its greatest consequence: that of overestimating the impact of influenza, which is usually a benign self-limiting infection.”

Beyond semantics, we need to consider the basic epidemiology of the flu. There are over 200 viruses that cause influenza and influenza-like illness and can produce symptoms similar to the everyday flu. It is estimated that 80 percent of flu-like illness reported during the “flu season” is not caused by influenza. As well, influenza viruses constantly evolve and mutate and since it takes up to nine months to develop the right vaccine, by the time flu season arrives, the flu shot may or may not match strains circulating.

Which is to say, fighting the flu is largely a hit-and-miss affair.

Jefferson wants to make sure flu policies affecting millions of people are based on proper, undeniable proof. Of the many health authorities around the world who support mass flu vaccine campaigns—those he irreverently refers to as “bioevangelists”—he claims the science shows they are mostly wrong: “There is no reliable evidence that inactivated influenza vaccines [the standard types of vaccines of today] affect either person-to-person spread of influenza or complications such as death or pneumonia…and [this] relates both to healthcare workers, community-dwellers and people in institutions.”

The flu vs. influenza-like illness

Jefferson didn’t intend to become a flu researcher. He spent the early part of his medical career as a physician in the British Army, serving tours in the Falklands, Bosnia and Croatia. A wide handlebar mustache that some said made him a caricature of the Modern Major General was perhaps a decoy, hiding the fact he was a rebel at heart.

In the spring of 1984, Jefferson was stationed in Germany with the 3rd Battalion Royal Anglian Regiment. He was ordered early one morning to report to his commanding officer, who told him that the Army had a terrible medical problem that needed his immediate assistance.

What was it? A new tropical disease needing investigation? A spate of injuries due to hostilities? No, nothing as exciting as that. The CO said that his unit had a terrible problem of acute respiratory disease, with the kind of chills, wheezing and high temperatures associated with garden-variety flu. He ordered Jefferson to “look into it.”

With access to decent surveillance data collected from the barracks by the Army’s medical teams, Dr Jefferson was shocked at the numbers, saying, “We had a system to calculate the working days lost, and it was astronomical.”

That clearly stoked his interest: “Most other medical researchers were interested in fancy stuff, exotic stuff, people killed in action and so on, as that was the stuff that got into the newspapers. But something as simple as colds and flu—which knocked out a brigade’s worth of soldiers every year—now that was something worth looking into.”

What Jefferson saw that day at the base was a sudden and inexplicable increase in ILI—influenza-like illness, and it left him scratching his head.

“I couldn’t really understand what was happening. There was no real activity outside the battalion—soldiers had it, the families had it, the children had it—wives had it…and I thought, what is this?”

He recalls that at that time, a rumour was circulating that the battalion was going to be deployed to Northern Ireland, a tour of duty they completed several times in the 1970s and ’80s. The regiment had lost 18 soldiers during these previous deployments, a fact fresh in the minds of the soldiers and their families. The upcoming deployment was understandably causing a lot of stress on the base and Dr Jefferson surmised that stress “perhaps explained why the battalion was hit with a high incidence of ILI.”

Five years later, he was able to work alongside Dr David Tyrrell who was tutored by some of the original discoverers of the influenza virus. Jefferson says that one of the most vital things he learned from Dr Tyrrell is the imprecision of the word “flu.” Tyrrell said that what people referred to as “the flu” was a “dangerous colloquialism,” and he stressed it was more appropriate to call the collection of symptoms “influenza-like illness.” As Jefferson says, “the confusion between influenza and influenza-like illness has led to an obsession with a single agent [the influenza virus] which is not based on any sound evidence.” With most of the extra illness suffered during flu season not caused by a verifiable flu virus, the situation, says Jefferson, is “potentially dangerous and misleading” because even if the best vaccine can prevent a proven flu virus, you’re only able to help a small portion of the people who become ill.

Jefferson served with the UN during the Yugoslav crisis, and reports: “I also observed the effects of ILI in terms of working days lost on British and UN soldiers.” In his opinion, “High rates of ILI were associated with stress, overcrowding and, of course, combat.”

Just not enough evidence

Nearly two decades later, Jefferson worries about the absence of quality research around other potential causes of flu-like illness, including the role of stress. Compared to the serious global moneymakers—the vaccines and antivirals which bring billions to the coffers of drug companies every year—something as simple as stress and its relation to the flu is simply not studied. There are some efforts to study methods to prevent virus transmission (masks and handwashing), but compared to the huge annual drug and vaccine enterprise focused on a virus, these efforts seem pitifully small.

The fact that a physician steeped in military tradition and respect for authority would turn out to be one of biggest anti-authoritarians in the influenza world is a delicious irony. Jefferson admits it is “absolutely heresy” to even imply that stress may play a role in causing the flu. He adds, it “undermines the living of very many people, and goes against the dogma of people selling vaccines and pills.”

The best way to counter the dogma is to find the most reliable evidence—preferably from an overview of all relevant studies, known as a meta-analysis. And that’s Jefferson’s game as part of the Cochrane Collaboration (www.cochrane.org), an international organization of consumers, scientists and researchers, gathering and systematically examining all the studies ever conducted to see how well a treatment works. Cochrane’s work is unique in at least two ways: it won’t take money from the drug or vaccine manufacturers to fund its research, and it uses the highest gold-standard methodologies when synthesizing research.

The Cochrane examination of flu vaccines in healthy adults, a body of literature spanning 25 studies and involving 59,566 people, finds an annual flu shot reduced overall clinical influenza by about six percent. It would reduce absenteeism by only 0.16 days (about four hours) for each influenza episode, a small effect given that the average flu bout lasts five to seven days. What was most illuminating was the authors’ conclusion: “There is not enough evidence to recommend universal vaccination against influenza in healthy adults.”

Jefferson and his colleagues found that most influenza studies are poorly designed and fail to prove the influenza vaccine is effective or safe for certain groups, such as the elderly and children under two. (In Canada, parents might be surprised to hear that Canada’s National Advisory Committee on Immunization recommends flu shots for kids six to 23 months old.)

Canada isn’t the only country with recommendations out of sync with the evidence. Earlier this summer, the UK’s National Health Service reported that they needed to find 1000 extra school nurses to give the flu vaccine to healthy children for the upcoming flu season. This was in response to government plans to expand the vaccination program to all children aged two to 17.

This decision was based on a series of computer models estimating that if 30 percent of the population were vaccinated for the flu, then there could be a reduction of 2000 deaths and 11,000 fewer hospital admissions. Expanding the program to children, seniors, pregnant women, and people who are considered at “higher risk,” would cost about $150 million per year, as reported in the UK’s Guardian newspaper. But will all that money actually deliver fewer deaths and hospitalizations?

The answer is “probably not.” Jefferson and others contend that using a computer model as the justification for an expanded flu vaccine program is very problematic. Tweak any of the assumptions in the model and you get what you want. Such an expanded program surely would please British-based pharmaceutical giant GlaxoSmithKline, a big player in the flu game—and should remind us of the politics of money behind any large public health program.

Immunizing BC’s healthcare workers

In late August, Provincial Health Officer Dr Perry Kendall announced that BC’s health care workers must either wear a mask or get the flu shot this season. His stated rationale was to improve the level of vaccination amongst health workers, which currently hovers around 40 percent.

When I asked why so many health care workers weren’t getting the shot, Kendall referred to surveys showing they avoid the shot for the same reasons as everyone else: they think they don’t need it, are concerned about the side effects, or got vaccinated in the past and still got the flu.

In the press release announcing the new policy he wrote the “influenza vaccine is extremely safe and the most effective way to prevent illness from the influenza virus, helping to prevent infection in healthy adults by as much as 80 percent.”

Yet like most health statistics, that 80 percent is misleading. In Jefferson’s opinion, “The best-conducted and largest trials in the healthiest populations show that you need to vaccinate 33 to 100 healthy people to avoid one set of symptoms of influenza (a ‘case’).” Peter Doshi, a researcher whose graduate thesis from Johns Hopkins School of Medicine focused on the politics of influenza policies, wrote in the British Medical Journal: “If CDC [Center for Disease Control] viral surveillance data is correct, then in recent years true influenza viruses have only caused an average of 12 percent of influenza-like illness.”

Since influenza vaccines do not work against non-influenza viruses or against all influenza strains, why do health departments around the world claim that vaccines are the “best way to prevent seasonal flu”?

This is not a trivial, or inexpensive question. BC already buys 1.1 million doses of vaccines each year to provide to those in the province who want one, at a cost of about $17.5 million. Moving to 95 percent coverage of BC’s health workers (assuming about 110,000 health workers) would cost in the neighbourhood of $1 million more per year.

So will immunizing health care workers prevent the spread of the flu to patients and save their lives? Jefferson’s examination at the Cochrane Collaboration of four cluster randomized trials and one cohort trial of nearly 20,000 health care workers showed “no effect on specific outcomes: laboratory-proven influenza, pneumonia or deaths from pneumonia.” Another research study observed the same phenomena as he did, but noted the vaccine was effective for ILI, hospitalizations for ILI, and death from all causes.

Regarding the latter study, Jefferson and colleagues found the effects on ILI and death such an unusual finding, they said that conclusion was due to bias, poor study design and reporting, and not a true effect. Claiming that the flu shot saved peoples’ lives from “all causes” strikes Jefferson as absurd: “They would have us believe that to avoid granny drowning in a pool (death from all causes) she should be vaccinated.”

BC’s Dr Kendall tends to agree that absurd findings often come out of observational trials and is aware of the Cochrane work, but still stands behind his recommendations for vaccinating health care workers, saying, “Overall I would say the preponderance of evidence shows a strong benefit in vaccination, particularly if you get a good match. I would still say that immunization campaigns have an outstanding safety record. I’d say they are a whole lot better than nothing.”

That sounds reassuring, but in those jurisdictions with high flu vaccination rates among health care workers (some as high as 95 percent)—is there a huge number of lives saved? The real answer: no one knows. And outstanding safety? Maybe, but recent research shows things might be a bit more complicated.

Just this September, Canadian researchers revealed a study showing that at the start of the 2009 “pandemic,” those who got the seasonal shot in the 2008-2009 flu season were more likely to get infected with the pandemic virus than people who hadn’t received it. Because researchers had noticed the phenomenon in the early weeks of the pandemic, Dr Danuta Skowronski, an influenza expert at the BC Centre for Disease Control in Vancouver, and a strong supporter of annual flu vaccine campaigns, more recently conducted a blinded test using ferrets (a mammal with human-like susceptibility to colds and flus). She found that those ferrets who got the seasonal flu shot got sicker when they were exposed to the pandemic H1N1 virus. Such research indicates there might be many potential unknowns capable of playing havoc with our immune systems.

Health authorities routinely tell us flu vaccines are perfectly safe. But there is a problem with the word “perfectly.” In Dr Jefferson’s words, “The potential harms of inactivated influenza vaccines have not been seriously studied and their reporting in small formal studies is very poor.” He reminds us that officials have cited “rare neurological syndromes observed after use of so-called pandemic vaccines.” When you’re injecting yourself with something, there is always the potential—even if very remote—for harm. Since the vast majority of people recover quite nicely on their own from a bout with the flu, are the risks worth it?

And how will we know if BC’s new program for healthcare workers is working? Kendall says BC will collect data on how many wear masks, how many workers are immunized and so on, essentially the “easier to measure” stuff such as compliance, coverage and absenteeism. But we won’t be measuring to see if the policy translates into fewer deaths and illness in patients, because, as Kendall says: “To do that kind of study you need a very large budget, you’d need to be able to have a substantial sampling of patients, you need to be culturing patients for influenza-like illness on admission and discharge. You could do it, but it would be a multimillion-dollar proposal.” In other words we won’t be measuring those things because it’s too expensive to find out if the vaccination policy does what it’s intended to do.

Dr Jim Wright of UBC’s Therapeutics Initiative is aware of the science around the flu vaccine. He used to get his annual shot until he looked a bit closer at the science and determined that there was no proof such vaccinations reduced deaths and hospitalizations. He concluded that promoting annual flu shots is one of the biggest uncontrolled trials of our time. He told me he is willing to roll up his sleeve or recommend his patients to do so, “but only as part of a randomized placebo-controlled trial designed to determine the benefits and harms of flu vaccination.” And he disagrees with Dr Kendall, saying, “A proper trial could be done with minimal expense and is badly needed to direct future flu vaccine policies.”

Follow the money

Let’s cast our minds back to June 11, 2009, when the World Health Organization declared the H1N1 flu outbreak a pandemic. Governments everywhere ordered billions of dollars worth of vaccines and antiviral drugs as fear of an epidemic spread like a contagion around the world. But critics accused the WHO of crying wolf and scaring member governments with predictions of a deadly pandemic. Within a year the entire enterprise would be revealed as fraudulent, with two studies charging that the WHO inexplicably changed the definition of a pandemic and that WHO’s decision-making was rife with conflicts of interest. We learned that the 2004 WHO committee which ordered world governments to set up immunization programs and stockpile antiretroviral drugs in the event of a flu pandemic, was stacked with scientists with ties to drug companies.

Jefferson believes that there is just too much money in, and reputations staked on, flu vaccines for many involved to be objective about them. He wrote “The main proponents are decision makers who are riddled with conflicts of interest: they make policy, evaluate it, update it, commission research and sometimes carry out—and in extreme cases have a stake in—the production of the pharmaceuticals.”

The key thought here is stunning: The push from health departments around the world to annually vaccinate their populations against the flu are based on poor, incomplete, or wildly-spun evidence. Scientific bodies such as the Cochrane Collaboration that refuse to take money from the pharmaceutical industry produce reviews that challenge the grandiose pronouncements of public health authorities the world over. Unfortunately, the authorities that drive global policies around the influenza vaccine and antiviral drugs are ignoring those challengers.

When I asked Kendall if he is possibly influenced by the vaccine marketers hanging around the Ministry of Health, and whether pharma money is shaping the decisions, he denied being influenced at all. I believe him, but unfortunately too many in positions of medical leadership avoid questioning vaccines for fear of excommunication. Even though much of the vaccine research is tainted, spun and unreliable, and paid for and promoted by the very companies that stand to profit, the reason vaccines are embraced with such religious fervour, in my view, is the belief system proclaiming that since vaccines have saved lives, and have caused us to turn the corner on many childhood diseases, they must be always good, for everyone, all the time. And we need more of them.

You can’t tell vaccine proponents they are wrong, or that maybe we need better and more reliable research before we start sticking everyone with a needle, because they’ve already made up their minds. This harkens to that saying of John Kenneth Galbraith: “Faced with the choice between changing one’s mind and proving that there is no need to do so, almost everyone gets busy on the proof.”

So in BC we now have a flu vaccination policy in place that affects every single health care worker in BC, in the hopes that it will save the lives of patients. We spend a lot of money convincing people to get vaccinated, and on the vaccine program itself. Yet the science is controversial and contradictory. Obviously, we need better science, but that’s not likely to happen; BC’s new policy won’t be evaluated thoroughly to see if it’s wasting our time and money.

And we certainly won’t be any closer to understanding if other factors might be playing a role in who does or does not come down with the flu this season. And that’s too bad. After all, the average person just wants to feel well, regardless of whether their aches, chills and headaches are caused by a virus, by stress, or by some other mechanism. As Dr Jefferson maintains, “the unknown causes and other organisms are far more frequent. They are largely ignored probably because of the fatal attraction represented by the availability of pharmaceutical interventions such as antivirals and vaccines.”

Alan Cassels is a drug policy researcher at the University of Victoria and the author of the recently released Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. As a former Canadian naval officer and UN peacekeeper he believes he has been vaccinated for every disease under the sun. He currently refuses to get an annual flu shot.