Swine Flu Vaccination, Treatment, and Prevention: A Common Sense Discussion and Review of the Evidence

Influenza, commonly called the flu, is a contagious respiratory illness caused by influenza viruses. In this article, we report emerging knowledge of the seasonal and swine flu epidemics, review the evidence on vaccinations, and introduce new evidence from research on common sense protective measures you can take. Counting all types of influenza, each year in the United States between 5% and 20% of the population will get the flu. 200,000 people will be hospitalized from flu-related complications and approximately 36,000 will die from flu-related causes.(CDC 2009) It is the elderly who are most substantially affected by the seasonal flu, making up 90% of flu-related deaths every year. By comparison, swine flu is most severely affecting young adults and teenage children.

Swine flu is a new type of flu virus genetically similar to flu viruses normally occurring in pigs. Often called H1N1, which refers to the two molecules Hemagglutinin and Neuraminidase that are found on the outside of viruses, swine flu is different from the virus normally found in pigs in that it combines genes from flu viruses found in pigs together with genes from bird and humans.(CDC 2009)

The H1N1 flu virus has adapted and exchanged genetic information with the common flu viruses, allowing transmission from human to human. This is in contrast with the Avian Flu outbreak, which started in China in 2003, in which the virus responsible (H5N1) was not able to change as readily from an animal-to-human transmitted form to one that could move from human-to-human. Furthermore, it is not yet known precisely how swine flu developed, which animal first passed it to a human, or when that actually occurred.(Fidler 2009) Therefore, swine flu is more accurately called the 2009 H1N1 flu.

While most 2009 H1N1 flu cases have been mild, with symptoms similar to those of seasonal flu, there are several more serious symptoms that can signal infection with H1N1. The Centers for Disease Control and Prevention has created a website that helps evaluate symptoms (flu.gov/evaluation), which presents a stepwise series of questions designed to help evaluate symptom relevance and severity. The interview concludes with an opinion as to whether your pattern of symptoms might represent likely 2009 H1N1 flu infection. In contrast to many of the self-check questionnaires available in the popular media, this site correctly places high importance on several cardinal symptoms that could signal serious H1N1 flu with complications: (1) your condition suddenly getting much worse, (2) shortness of breath or cough, (3) diarrhea or vomiting, and (4) your condition still getting worse after seven days (five for a child). Most people whose death has been attributed to 2009 H1N1 infection died because they developed a second infection, usually bacterial pneumonia.(Chowell, Bertozzi et al. 2009)

England’s National Health Service has more precisely defined the specific circumstances under which people are known to be at increased risk of developing serious 2009 H1N1 flu complications. These would be people with:

» chronic (long-term) lung, heart, kidney, or liver disease
» chronic neurological disease, multiple sclerosis, or Parkinson’s
» immune system suppression (from disease or treatment)
» diabetes mellitus
» patients treated for asthma in the past three years
» pregnant women
» people aged 65 and older
» young children under five

Their report also emphasized that people in these groups who develop flu symptoms should get tested quickly to identify whether they do in fact have 2009 H1N1 influenza and, if so, that they be treated with antiviral medications.

There are reasons for both heightened – and reduced – concern about the 2009 H1N1 flu. It has shown the ability to spread very quickly through the global population, aided by modern air travel. As of October 17th, 2009, in 191 countries and territories, over 414,000 laboratory-confirmed cases of 2009 H1N1 flu have been documented and, of those, nearly 5,000 people have died of the flu.(World Health Organization 2009) The anticipated fall/winter resurgence of the flu is happening, and earlier in the season than expected.

One reason for heightened concern is the October 10th announcement by the CDC that 76 children in the US have died of 2009 H1N1 flu, 19 of them in that prior week. The usual seasonal flu kills between 46 and 88 children a year, suggesting that the new H1N1 virus could claim more children than seasonal flu.(CDC 2009)

This strain of flu virus is also of concern because most of us have no immunity to it, since it has a very different structure and activity than the more common seasonal flu viruses that hit every year. The World Health Organization has predicted that over one third of the world’s population will be infected with 2009 H1N1 flu in the next few years.(WHO 2009)

The symptoms of 2009 H1N1 flu have, so far and for most people, been milder than the deadly influenzas of the past century. This has led many health experts to predict that the 2009 H1N1 flu pandemic will not be as dire as the original projections. Some have hypothesized that older people might actually be less affected because those born before 1957 may still have immunity to the types of viruses that spread during outbreaks in the 1950s.

It also appears that the actual death rate related to H1N1 flu virus is much lower than originally feared. The overall death rate due to H1N1 flu virus in Mexico was estimated to be around 0.4% of all people infected.(Fraser, Donnelly et al. 2009) The rate in the United States is approximately 1%.(WHO, 2009) This is a similar rate to that seen with the ordinary flu virus. The death rate from laboratory-confirmed cases officially reported to WHO as of August 2009 is much lower (0.08%). Furthermore, because the true number of H1N1 cases is likely to be much higher than what has been reported to WHO, these are likely to be overestimates of the true death rate.

WHO laboratory surveillance has demonstrated that viruses from all of the 2009 H1N1 flu outbreaks are virtually genetically identical, meaning the virus has not mutated to a more virulent form. Similarly, symptom patterns within these different 2009 H1N1 flu outbreaks are consistent in different countries, and most patients have only mild illness. Furthermore, the incidence of severe and fatal illness is low.(WHO 2009)

Even though a low proportion of all people who develop 2009 H1N1 flu will ultimately die of it, because a higher proportion of people will become infected than they would from seasonal flu, this may still mean that there may be many deaths overall from 2009 H1N1 flu.

Since the 2009 H1N1 flu competitively infects animals more quickly than seasonal flu, but does not share genetic information with other flu strains, it is therefore not likely to mutate into a “superbug”.

Availability of 2009 H1N1 flu vaccines is already limited, and 2009 H1N1 flu shots will be prioritized for groups most at risk of contracting the virus or developing severe complications of influenza infection. Those would include children, people caring for young infants, younger adults, women who are pregnant, health care workers, and people with chronic illness. In most states, 2009 H1N1 flu shots will be available at hospitals, public health clinics, and pharmacies, with requests evaluated by state health departments. Businesses, which are used to obtaining and providing seasonal flu vaccines, will not be able to obtain 2009 H1N1 flu vaccines unless they have medical providers licensed to provide vaccinations.

Although the regular seasonal flu vaccine became available earlier than is normally seen, nevertheless it is 2009 H1N1 flu that is the dominant strain and the first 2009 H1N1 flu vaccine was not available until October 2009. The CDC estimates that approximately 195 million doses are expected to be available over the next six months. It remains to be seen how effective the 2009 H1N1 flu vaccine will be.(CDC 2009)

In an in-depth analysis of the uncertainties surrounding the effectiveness of vaccination, the magazine The Atlantic asks the question “what if everything we think we know about fighting influenza is wrong? What if flu vaccines do not protect people from dying — particularly the elderly, who account for 90 percent of deaths from seasonal flu?” Health authorities have claimed the death rate due to influenza in elderly persons is reduced by half, thanks to vaccination. (Govaert, Thijs et al. 1994) However, this is an incredible number. The Atlantic writes on, saying that “Tom Jefferson, a physician based in Rome and the head of the Vaccines Field at the Cochrane Collaboration, a highly respected international network of researchers who appraise medical evidence, says: ‘For a vaccine to reduce mortality by 50 percent and up to 90 percent in some studies means it has to prevent deaths not just from influenza, but also from falls, fires, heart disease, strokes, and car accidents. That’s not a vaccine, that’s a miracle.’”(Brownlee and Lenzer 2009) Dr. Jefferson’s three meta-analysis publications summarizing the results of hundreds of studies on vaccine safety and effectiveness are discussed below.

Researcher Lisa Jackson in 2006 published a critical analysis of vaccine effectiveness, suggesting there is a temporal (time-related) bias present in most influenza effectiveness studies. She did something no researcher had done before: she analyzed death rates comparing vaccine users and non-users not only during flu season, but also before flu season began. In her study, she examined the health records of 72,527 people age 65 or older that had been followed over an 8-year period. She found that the risk of death from any cause in vaccine users was 60% lower before influenza season. This tells us that there is, in fact, a “healthy user effect” at work: people who are already healthier are choosing vaccines. She concluded that the magnitude of the time-related bias account entirely for the lower risk of death among vaccine users during the flu season.(Jackson, Jackson et al. 2006) This suggests what we’re seeing about the benefits of flu vaccine may be more about who’s choosing to get vaccinated than it is about the vaccine’s effectiveness itself.

Dozens of studies have been conducted showing the ability of influenza vaccines to successfully induce an immune reaction in the body. However, few studies have been conducted using the gold standard of clinical research — the randomized, placebo-controlled trial — in testing whether influenza vaccines actually prevent the flu or prevent deaths due to the flu.

There are several important questions to consider when reading the results of influenza research studies, questions that rarely appear in reporting in major media outlets. It is well known that the goal of influenza vaccination policy is to reduce the death rate due to influenza by specifically targeting people aged 65 or older. But is this an effective strategy? Researchers at the National Institutes of Health in 2007 pointed out that even though the proportion of people in the United States vaccinated for the flu has increased over the past two decades from 15% to 65%, there has been no decline in influenza-related deaths since 1980.(Simonsen, Taylor et al. 2007)

Research results presented at the Infectious Diseases Society of America’s 2009 annual meeting in Philadelphia: Pregnant women who receive flu vaccinations are protected not only for themselves, but for their babies as well. They studied 350 pregnant women and found that when women received the flu vaccine during pregnancy, the vaccine prevented hospitalization up to 85 percent of the time in their babies age 6 months or younger. (Reuters Health, 2009)

2009, Statistics Collaborative, Inc., Washington, DC: A meta-analysis combined the results of nine randomized clinical trials, including a total of nearly 25,000 children aged 6 to 71 months and 2,000 children aged 6 to 17 years. Compared to placebo, live-attenuated vaccines in young children reduced the occurrence of flu infection by two-thirds. Compared to the inactivated form of vaccine, live attenuated vaccines reduced the occurrence of flu infection by nearly half.(Rhorer, Ambrose et al. 2009)

2009, University of Michigan School of Public Health: In a randomized, double-blind, placebo-controlled trial of licensed inactivated and live attenuated influenza vaccines in healthy adults during the 2007-2008 influenza season, there was a two-thirds reduction in risk of flu with the inactivated vaccine, and one-third reduction with the live attenuated vaccine. This finding contrasts with results from the above-mentioned meta-analysis, where the live-attenuated vaccine was more effective.(Monto, Ohmit et al. 2009)

2009, Cochrane Collaboration: A team led by Tom Jefferson, one of the few experienced influenza researchers apparently willing to critically question vaccination research and policy, conducted a systematic review paper that examined the relationship between who funded a study, the prestige level of journals publishing this research, and whether the authors’ conclusions are supported by the data. They identified 259 studies comparing influenza vaccines to placebo or no intervention. They found that studies published in prestigious journals were almost always funded by pharmaceutical industry sources. They also found that the studies conducted with higher quality methods and writing were significantly less likely to find effectiveness of vaccines than lower quality studies. It should be noted that the Cochrane Collaboration is an independent group of researchers worldwide who volunteer their time in the interest of conducting critical evaluations of evidence from clinical research, unconstrained by political influence of governing bodies or research funding.

2008, Cochrane Collaboration: Another effort by Jefferson’s group assessed the effectiveness of influenza vaccines in healthy children, documenting adverse events from influenza vaccines, and seeking studies of any influenza vaccine in healthy children under 16 years of age. His team found fifty-one studies, including nearly 300,000 children; data from randomized controlled trials showed the live attenuated vaccines had an ability of between 33% and 82% to prevent influenza in children older than two, compared with either placebo or no treatment. With inactivated vaccines, that ranged between 36% and 59%.

This meta-analysis found “extensive evidence of reporting bias of safety outcomes from trials of live attenuated vaccines.” Furthermore, the authors concluded that “influenza vaccines are efficacious in children older than two but little evidence is available for children under two.”(Jefferson, Rivetti et al. 2008)

2006, Cochrane Collaboration: Jefferson’s group published a meta-analysis of studies on anti-viral medication, concluding that “the use of amantadine and rimantadine should be discouraged. Because of their low effectiveness, neuraminidase inhibitors should not be used in seasonal influenza control and should only be used in a serious epidemic or pandemic alongside other public-health measures.”(Jefferson, Demicheli et al. 2006) It is important to note that another unanticipated consequence of widespread use of antiviral medications for flu prevention is their accumulation in river water, leading to the development of resistant strains of flu. When Tamiflu is passed through the body, nearly all of it will end up in the environment in the active form as it is removed by sewage treatment plants. Should Tamiflu resistance develop in birds, it is most likely that those will be the typical seasonal flu and avian viral strains, which cause more deaths than H1N1 and, unlike H1N1, pass through birds.(Raloff 2009)

On October 8th, 2009, researchers from Mexico reported in the British Medical Journal an astonishing finding: that the ordinary seasonal inactivated vaccine provided protection against this year’s pandemic influenza, A/H1N1 2009. Working in a hospital in Mexico City over a three-month period, they analyzed the case records of 60 patients with laboratory-confirmed influenza A/H1N1, and compared those to 180 controls with other diseases not related to influenza or pneumonia. To make them more comparable, cases were matched with controls by age and socioeconomic status. They found that none of the 8 flu patients who had been vaccinated with seasonal flu vaccine died (0%), whereas 18 of the 52 unvaccinated patients died (35%). Additionally, while only 1 of the 8 flu patients (13%) required intensive respiratory support, nearly half (25 of 52, or 48%) of the unvaccinated patients did require it. The authors concluded that since “none of the vaccinated cases of influenza A/H1N1 died… seasonal vaccination might protect against the most severe forms of the disease.”(Garcia-Garcia, Valdespino-Gomez et al. 2009)

Since the first outbreak of H1N1 in the spring of this year, five biopharmaceutical companies – Novartis, GlaxoSmithkline, MedImmune, CSL, and Sanofi-Pasteur – have been developing and testing vaccines. The blog The scientist reports that CSL (Australia) stands to make approximately US$218 to $262 million in profit from the manufacture of vaccines. Maryland-based MedImmune has a contract to provide 40 million doses of vaccine, worth over $450 million; 3.5 million doses of that vaccine have been approved for release by the FDA. Sanofi-Pasteur has a contract to provide over a million doses of H1N1 flu vaccine. Novartis has received a $690 million order from the US government. The government has also invested $35 million into Connecticut-based Protein Sciences to develop a recombinant 2009 H1N1 flu vaccine infecting insect cells with the virus, an approach that may be faster for developing vaccines than the traditional egg yolk-based method.(The Scientist: Newsblog 2009)

It is estimated that $1.5 billion will be spent for the 250 million doses of 2009 H1N1 flu vaccine ordered by the US government, which will be distributing at no cost to doctors, pharmacies, and schools. This money ultimately comes from the taxpayers.(Fahmy 2009)

It is not clear what the relationships are between these bio-pharmaceutical companies and government officials. Because the development, testing, and manufacturer of vaccines is very costly, the market for vaccines is much smaller than for other drugs, and pharmaceutical companies have over the past decade have been reducing their investment in vaccines, or abandoning them altogether.(Offit 2005) However, fears of bioterrorism have opened new opportunities for profitability. Developers of H1N1 vaccines will be protected until March 31, 2013 from liability under the Public Readiness and Emergency Preparedness Act, signed into law by then-President Bush in 2005.(Copper 2007; Office of General Counsel Texas Department of State Health Services (DSHS) 2009)

Human rights concerns have been expressed about the actions of certain governments following the pandemic-alert, such as trade and travel bans, and China’s quarantining of Mexican and Canadian nationals recently arrived or already present in China. Allegations of unfairness have also been raised by Indonesia and other developing countries revolving around their limited access to new discoveries from research on influenza virus specifically related to H1N1.(Fidler 2009)

There is early evidence that the newly developed H1N1 flu vaccines are doing their intended job: to provoke an immune response by exposing the vaccinated person to small amounts of viral material. Two new randomized trials, one with 240 people(Greenberg, Lai et al. 2009) and one with 175(Clark, Pareek et al. 2009), have demonstrated that a single-dose vaccine has prompted a positive immune response. While the level of enduring protection is as yet unknown, the authors of one trial write that the immune response is “likely to be associated with protection within 14 days after a single dose is administered.”(Clark, Pareek et al. 2009) The CDC’s Advisory Committee on Immunization Practices recommends that the following five groups receive vaccination priority:

» pregnant women
» persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, and daycare providers)
» health-care and emergency medical services personnel
» persons aged 6 months to 24 years
» persons aged 25 to 64 years who have medical conditions that put them at higher risk for influenza-related complications.(Clark, Pareek et al. 2009)

However, the long-term safety is as yet unknown. An editorial in a recent issue of the medical journal The Lancet questions the safety of an H1N1 vaccine, which due to the widespread fear of pandemic, is being rushed through fast-track regulatory approval processes that won’t include the usual safety testing given other vaccines. This means vaccine safety can only be monitored with post-marketing surveillance, implemented after the vaccine has been distributed and delivered. This is potentially a concern, given long-term complications that followed mass vaccination during the 1976 H1N1 outbreak in the United States.(2009) Because of those complications, which included the neurologic disorder Guillain-Barre syndrome,(Nachamkin, Shadomy et al. 2008) the vaccination program was stopped and the vaccine withdrawn.(2009) Cases of Guillain-Barre syndrome attributed to vaccination were about 1 more case for every 100,000 people who got the swine flu vaccine. By comparison, it appears that the chance of severe flu complications is higher than the chance of getting Guillain-Barre after getting the flu vaccine. Additionally, monitoring systems for this complication have been established, which were not present in 1976.(CDC, 2009) Nevertheless, over one-third of parents oppose H1N1 vaccination, according to an Associated Press-Gfk poll.

If you decide to become vaccinated, avoid acetaminophen (paracetamol) at the time of and following your vaccination. While it successfully prevents developing fever related to the vaccine, it also reduces the body’s immune response to the vaccine, perhaps lowering the vaccine’s effectiveness.(Reuters 2009)

Take practical steps to lower your stress levels. In meta-analysis research published this year, self-reported stressful life events or perceived stress led to lower antibody responses to influenza vaccination, regardless of age. (Pedersen, Zachariae et al.
2009) It is ironic that global information campaigns have served to increase stress related to fear of influenza.

On September 25th, WHO issued new treatment guidelines based on their assessment of international clinical experience in acute flu treatment. These guidelines state that early treatment after appearance of symptoms with the antiviral drugs oseltamivir (Tamiflu) or zanamivir (Relenza) reduces the risk of flu complications, especially in people are at increased risk of developing complications, those with severe illness or those with worsening signs and symptoms. Most samples of 2009 H1N1 influenza tested worldwide are responsive to Tamiflu (WHO, 2009)

There are two scenarios in which a person with acute flu infection may have high risk resistance to Tamiflu: in patients with severely compromised or suppressed immune systems who have prolonged illness or patients who have already been treated with Tamiflu (especially for an extended duration), but in whom there is persistent evidence of viral replication.

To date, 28 flu viruses that are Tamiflu-resistant have been detected worldwide, but none of these have shown resistance to Relenza. Of these 28, nearly half were isolated from patients who had been using Tamilflu for post-exposure prophylaxis (the use of a drug preventively following exposure to someone with known 2009 H1N1 flu).(World Health Organization 2009)

WHO recommends against using antiviral drugs for prevention (antiviral drugs are different from vaccines). If you’ve been exposed to someone infected with 2009 H1N1 flu, and you have a compromised immune system, are pregnant, are under age 25, or have a history of previous lung weakness, then WHO recommends close monitoring for symptoms, followed by prompt early antiviral treatment if you develop symptoms.(World Health Organization 2009)

While the common sense ideas suggested by public health experts are useful (hand washing, fresh air, coughing into your elbow), there are many more approaches that could provide additional protection. Research results of these approaches are reviewed here.

Vitamin D3: Although the winter season’s closer proximity to other people and reduced air circulation makes it easier for flu viruses to transmit from one person to the next, this is by no means the whole story. A greater culprit may be a combination of reduced exercise resulting in weaker respiratory fitness and vitamin D deficiency induced, in part, by less exposure to sunlight. Children admitted to intensive care for respiratory infection have vitamin D levels that are nearly half the level of other children. (McNally, Leis et al. 2009)

Vitamin D3’s ability to prevent flu infection was studied by Dr. John Cannell, Executive Director of the Vitamin D Council. Cannell has estimated that vitamin D plays a role in the repair and maintenance of more than 200 human genes in a wide variety of tissues. Included in these genes is the one responsible for the polypeptide called cathelicidin, a naturally occurring broad-spectrum antibiotic made in your white blood cells. For people living in sunny areas, normal serum vitamin D levels are between 40-70 ng per mL. There are three ways to boost vitamin D levels: sunlight, artificial ultraviolet B (UVB) radiation, and vitamin D3 supplements. 2,000-7,000 IU vitamin D per day should be sufficient to maintain year-round levels of vitamin D in the blood(Cannell and Hollis 2008), although people with chronic kidney disease should stay below 2,000 IU daily. Cannell also cogently suggests that vitamin D deficiency may be one of the chief culprits behind seasonal influenza epidemics,(Cannell, Vieth et al. 2006) pointing out evidence from intervention trials that have shown vitamin D3 prevents respiratory infections in children. (Cannell, Zasloff et al. 2008)

There has also been research that specifically compared the effectiveness of different doses and time intervals of vitamin D3 supplements in achieving higher serum levels of vitamin D. Volunteers were given 600 IU/day, 4200 IU/week, 18,000 IU/ month, or placebo. After 4 months, researchers found that daily vitamin D3 was more effective than weekly, and monthly was the least effective, in achieving higher serum vitamin D levels.(Chel, Wijnhoven et al. 2008)

Chinese Herbal Medicines: A 2005 meta-analysis analyzed 11 studies totaling 2,088 participants. Some of those studies yielded positive results showing better effectiveness of Chinese herbal medicines for flu symptoms, compared to antiviral or antipyretic-analgesic drugs or the combination of both. Three studies mentioned adverse reactions but there was no detailed reporting of those effects. Beneficial effects included such outcomes as quicker reduction of fever and symptom improvement.(Chen, Wu et al. 2005) All 11 studies used different herbal combinations, and practitioner guidance would be recommended for the selection of herbs. None of these preparations are within the range of Chinese herbal patent medicines commercially available in the United States in pill form, but nearly all are composed of herbal roots and leaves commonly found in Chinese herbal pharmacies. We have permission from the publisher to provide you, upon request, a copy of the table of herbs used in these preparations.(Wiley Interscience 2009) One preparation, called Gan Mao Capsule, compared favorably with the antiviral medication amantadine (Symmetrel).

Probiotics: The use of probiotics shows early promise of both improving the body’s innate protection against developing influenza infection and also strengthening immune response to influenza vaccine. In an animal study, probiotics helped mice prevent influenza infection.(Liaskovs’kyi, Rybalko et al. 2007)

For older people, influenza vaccination results in weaker immune responses compared to younger adults. Researchers in France tested the effect of a twice-daily probiotic drink on immune response to influenza vaccination in a study involving healthy volunteers over age 70. A total of 308 elderly volunteers took probiotics or placebo twice daily for 7 weeks or 13 weeks. At 4 weeks into the trial, a vaccine containing 3 viral strains (H1N1, H3N2, and B) was given. Immune response against the 3 viral strains was significantly higher in the probiotic group. These benefits were still present 5 months after vaccination.(Boge, Remigy et al. 2009) The study was sponsored by Dannon Yogurt.

Rhodiola Root: Flavonols extracted from Rhodiola rosea root showed neuraminidase inhibitory activity. This means that the drug blocks the activity of the viral neuraminidase protein, which prevents the virus from reproducing. This potent inhibitory effect was demonstrated in two flu strains, H1N1 (swine flu) and H9N2 (another type of influenza virus).(Jeong, Ryu et al. 2009)

The active ingredient in this herb is a member of the class of antioxidant compounds called flavonoids (or bioflavonoids). Important dietary sources for flavonoids are citrus, ginkgo, tea, red grapes and red wine, green leafy spices (such as parsley), soybeans and other soy foods, legumes, red, purple and blue berries, and dark chocolate.(Beecher 2003) Flavonoids frequently possess neuraminidase inhibitory activity,(Liu, Wang et al. 2008) suggesting that perhaps diets featuring flavonoid-rich foods may have flu-prevention effects.

Elderberry Extract: In a recent study from Florida, researchers found that flavonoids from the elderberry were able to bind to and prevent H1N1 infection in vitro. The formulation used was an ordinary crude extract prepared without separation of specialized derivatives or fractions. The elderberry extract was able to both inhibit H1N1 viral infection by binding to H1N1 virus particles and also block the ability of the virus to infect host cells. The ability of elderberry extract to inhibit H1N1 was similar to that seen with the anti-influenza drugs Tamiflu and Amantadine. (Roschek, Fink et al. 2009)

Ginseng: Four randomized, placebo-controlled trials of ginseng have been conducted: An extract of North American ginseng was tested for its ability to prevent upper respiratory tract infections. North American ginseng can favorably influence immune responses. In a randomized, double-blind, placebo-controlled study conducted at the onset of the influenza season, 323 subjects aged 18 to 65 with a history of at least 2 colds in the previous year were recruited into the study, which was conducted in Edmonton, Alberta and lasted 4 months. They were randomly assigned to take either 2 capsules daily of North American ginseng extract or a placebo. The researchers found that in the ginseng group, as compared to the placebo group, there were: a 25% lower average number of colds, a reduction by half in the proportion of subjects with 2 or more colds, and an over 1/3 reduction in the total number of days cold symptoms were reported.

In two other randomized trials involving 198 nursing home residents, ginseng extract at 200 mg compared to placebo achieved an 89% reduction in risk of respiratory infection (only 1 of the 97 ginseng users became infected).(McElhaney, Gravenstein et al. 2004)

In a follow-up study of 43 adults age 65 or older, ginseng reduced the likelihood of developing respiratory symptoms by 48%, similar to that reported with vaccines, and the severity of those symptoms was reduced by half.(McElhaney, Goel et al. 2006)

While it’s unknown whether ginseng would protect against H1N1 influenza virus, and not just less complicated respiratory symptoms, it nevertheless makes sense to discuss with a medical practitioner whether ginseng is compatible with currently used medications or medical conditions.

Chlorella: A 400 mg daily dose of chlorella failed to boost the immune response to trivalent inactivated vaccine, in a randomized, double-blind placebo-controlled trial of 124 healthy adults.(Halperin, Smith et al. 2003)

Bu Zhong Yi Qi Tang (a Chinese herbal formula also called Hochu-Ekki-To): This herbal formula failed to improve immune response to influenza vaccine (including H1N1) in a study of thirty-two healthy subjects randomly assigned to two groups (control and herbal groups).(Hamazaki, Sawazaki et al. 2007)

Learn and Regularly Practice Tai Chi: Researchers at the University of Illinois at Urbana-Champaign conducted a study to investigate whether the practice of tai chi and qigong would strengthen immune responses to the flu vaccine among older adults. Because their risk of flu complications such as pneumonia is higher, older adults are advised every year to have a flu shot. However, in many cases older adults’ immune response to the vaccine is not strong enough to provide them adequate protection from flu infection. Fifty adults in their 70s enrolled in this study, which began with a flu vaccine shot. Of those 50 people, approximately half learned tai chi and qigong, consisting of three weekly one-hour classes. The other half were the control group. After five months, blood tests revealed that people in the tai chi group developed more antibodies to the flu virus than the control group.(Yang, Verkuilen et al. 2008)

Exercise: A study of over 24,000 people, conducted in Hong kong in 1998, found that moderate exercise of up to three times per week substantially reduced both the severity of flu symptoms and the likelihood of dying from the flu.(Wong, Lai et al. 2008)

What About Masks?: Ordinary surgical masks are not effective protection against flu infection, according to a recent Institute of Medicine report. Best is the type called N95, which costs less than $5.

Keep Your Feet Warm: Many traditional medical systems have observed that cooling of the body surface leaves a person more vulnerable to common cold. In a study involving 180 healthy subjects, half were randomly assigned to either receive an ice water foot bath or be in the control group. All were asked to be alert for symptoms of common cold, both before and immediately after the foot chilling, and twice daily thereafter up to 5 days. Chilling of the feet was associated with common cold symptoms in 10% of chilled subjects, approximately twice the rate compared to the control group.(Johnson and Eccles, 2005) While it’s unknown whether this would protect against influenza virus as well, and not just common cold, nevertheless it makes sense and couldn’t hurt to follow this approach.

Low-dose Interferon: Researchers from Freiburg University and Friedrich Loeffler Institute in Germany announced animal research results showing that as little as one intranasal application of low-dose interferon reduced influenza viral concentration in the lungs sufficient to protect mice against influenza infections, which would have otherwise been lethal, without any evidence of toxicity.(Medical News Today 2009) Similar research was published in 2007.(Beilharz, Cummins et al. 2007) Additionally, a Phase 2 clinical trial of low-dose oral interferon is being conducted in Australia with healthy subjects being exposed to H1N1 and other viruses. US-based clinical trials are planned.(Medical News Today 2009)

That depends on which health agency you take more seriously. While eating pork has been declared safe by the CDC, the Food and Agriculture Organization of the United Nations (FAO) and the World Organization for Animal Health (OIE), nevertheless the WHO has said that meat from pigs infected with the new H1N1 virus shouldn’t be eaten by humans. The WHO has said that flu viruses may survive the freezing process and could therefore be found in thawed animal blood and meat. WHO is also recommending workers in pork processing plants wear protective equipment. While WHO also recommends that farm workers “minimize contact with sick pigs and report such animals to relevant animal health authorities,” labor conditions may not always allow workers the self-perceived authority to file such reports.

What We Know: The H1N1 virus has clearly been very successful at quickly establishing a global reach. Early characteristics of the flu’s Northern Hemisphere resurgence in fall 2009 are that infection severity and flu-related death rate are much lower than was originally feared. International regulatory response to the viral pandemic has triggered a global panic perhaps out of proportion to the actual lethality of the virus itself.

What We Don’t Know: Although a few small-scale studies have demonstrated that H1N1 vaccines are provoking the intended response of the immune system, we don’t yet know whether they will protect people in large populations from developing H1N1 flu infection, nor whether they will reduce the proportion of severe or fatal complications among those infected. We also don’t know whether the studies currently being done are giving us the information we need. It’s a curious anomaly that in the field of influenza vaccination, very little research is being conducted using the gold-standard demanded in many other medical conditions: placebo-controlled trials, which would randomly assign test subjects to receive either vaccine or placebo. Quoting from the above-mentioned meta-analysis by Tom Jefferson, “it was surprising to find only one study of inactivated vaccine in children under two years, given current recommendations to vaccinate healthy children from six months old in the USA and Canada. If immunization in children is to be recommended as a public health policy, large-scale studies assessing important outcomes and directly comparing vaccine types are urgently required.”(Jefferson, Rivetti et al. 2008)

In considering this discussion, it’s also important to recognize the difficulty of conducting influenza effectiveness trials, given the constrained timeline of a single influenza season, the ability of influenza viruses to mutate, variations in how many people are affected, and the difficulty of predicting in advance which viral strain will be dominant.(Beran, Wertzova et al. 2009)

The Bottom Line: While it’s too early to say whether vaccination is safe in humans and/or effective against H1N1 infection, nevertheless it’s important to be aware of the issues and controversies surrounding this globally important viral pandemic. The common-sense measures involving nutrition, exercise, and personal hygiene are clearly in the “could help/can’t hurt” category of sensibility.

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