It's the season for the annual flu vaccine, and the campaign to get the vulnerable protected has been gathering steam. Using the slogan 'Flu Safe', the UK's National Health Service (NHS) campaign is driven by two key arguments: that flu can be a killer; and the flu shot prevents it. But although flu can be a killer, especially among the elderly, there's no independent evidence to suggest the flu vaccines work.
Health regulators have consistently issued sensational forecasts and statistics about the lethal effects of flu. In 2005, the World Health Organization (WHO) estimated that around 7.4 million people would die from avian flu (influenza A, H5N1 virus), while the then chief medical officer for the UK, Sir Liam Donaldson, reckoned 750,000 of the fatalities would be British-and it was a case of when, not if. In the event, the numbers of deaths from the virus were counted in the hundreds.
America's Centers for Disease Control and Prevention (CDC) has come clean about its own predictions of annual flu deaths, which it admitted it has been inflating for the past 20 years. Each year, the CDC has estimated that 36,000 Americans would die from flu, although the actual numbers have usually been closer to 3,000. Challenged by its false estimates, the CDC admitted that its prediction was based on an average, which included a couple of years when there was a virulent epidemic of the H3N2 virus. In those years, deaths reached 49,000 in the US, although the average for a typical year remains at around 3,000 deaths. There are around 700 deaths from flu each year in the UK.
Announcing that it would stop its traditional 30,000-deaths forecast, the CDC's David Shay said: "Flu really is unpredictable. We don't know what the impact of flu will be at the beginning of a particular season." Unrepentant, Shay said the best way to prevent flu deaths was to have the annual vaccine, which he said should be available to everyone over the age of six months (Reuters, August 26, 2010; www.reuters.com/article/2010/ 08/26/us-flu-usaidUSTRE67P3N A20100-826).
Does it work?
According to the NHS website, "studies have shown that having a flu jab provides effective protection against flu". On the face of it, the comment seems to be supported by the evidence. Researchers carried out an analysis of 31 studies on flu vaccines used between 1967 and 2011, and concluded that the hots were effective 67 per cent
of the time, especially among immune-compromised adults who were HIV-positive.
It also protected 70 per cent of healthy adults, aged between 18 and 46 years, and 66 per cent of healthy children aged between six and 24 months (Lancet Infect Dis, 2012; 12: 36-44).
Ironically, it had the least protective effect among the elderly, the most vulnerable group. A person aged 65 or older is more than 10 times as likely to die from influenza-associated symptoms than someone in the 50 to 64 age group, even after being vaccinated (Lancet Infect Dis, 2007; 7: 658-66).
But dig a little deeper and the picture becomes less clear. Most of the positive studies were paid for by the vaccine manufacturer, and these results cannot be trusted, such is the level of influence and spin in supposedly 'scientific' studies. One review of 274 vaccine studies found that all of those sponsored by the manufacturer concluded the vaccines worked, while almost none of those that had ind-ependent funding did so.
It's not hard to see why the flu shots can't work. A virus is a dynamic entity that constantly changes, and there are more than 200 viruses that can cause influenza and influenza-like illnesses. All flu viruses change their antigens (an often toxic agent that triggers an antibody response) to evade recognition by the host's immune system. These modifications take place rapidly and often: a flu virus can mutate up to a million times more often than a DNA virus (Vaccine, 2002; 20: 3068-87).
Vaccine designers in the WHO Global Influenza Programme have to prepare new antigen formulations every year, often nine months ahead of the next major flu outbreak. Their role is therefore mainly predictive as they try to second-guess what the new flu virus strain will be to achieve a perfect antigenic match.
Only the vaccine that is a perfect match to the virus can combat it, and achieving this is almost impossible, given the infinite permutations that the virus can undergo (Lancet, 2005; 366: 1139-40). Ironically, and not surprisingly, the perfect flu vaccine is always a year too late.
This has been borne out by the Cochrane Collaboration, an independent and authoritative medical research group, which carried out a review of studies looking at the effectiveness of various flu shots. In all, they analyzed 50 studies involving more than 70,000 people, some vaccinated, some not. In'ideal conditions'-the extremely unlikely possibility that the vaccine perfectly matches the virus-33 people would have to be vaccinated to avoid just one flu attack. In 'average conditions'-the real world of vaccines that only partially match the virus-100 people would need to be vaccinated to avoid one case of flu.
At best, say the Cochrane researchers, the flu shot may be effective against only influenza A and B, which represents only 10 per cent of all circulating viruses. And the vaccine doesn't even prevent complications. Vaccinated people who caught the flu still ended up in hospital or took as many days off work as an unvaccinated person if their immune system was already poor.
Then there are the adverse reactions or side-effects to the shot itself. The NHS website is riddled with complaints from people who had the jab in previous years and describe it as "the worst decision I ever made". Many suffered debilitating side-effects from the jab that were every bit as bad as having the flu itself, and most people complained of catching a cold, and having chest pain and wheeziness afterwards.
More seriously, the flu shot can cause Guillain-Barr'e syndrome, a condition where the immune system attacks the peripheral nervous system. The effects can be distressing, leading to paralysis, and are incurable. According to the Cochrane researchers, the jab causes one such case in every million people vaccinated.
The Cochrane analysis is devastating, but the true picture is likely to be even worse. The researchers point out that 15 of the studies had been funded by the vaccine manufacturer, so those results were probably slanted in the vaccine's favour. A suspiciously high number of the trials also took place in 'ideal conditions', where the vaccine perfectly matched the virus (Cochrane Database Syst Rev, 2010; 7: CD001269).
Yet, despite its authority and independence, the Cochrane analysis has been completely ignored by the NHS. Instead, its Joint Committee on Vaccination and Immunisation (JCVI) preferred to rely on an un-published study prepared, in part, by the government's own Health Protection Agency.
This study showed the effectiveness of the flu shot and how it could be extended to other groups, especially children and pregnant women, said a JCVI statement (JCVI Statement on the annual influenza vaccination pro-gramme-extension of the programme to children, 25 July 2012).
Women and the elderly first
More people could suffer from flu this year because the WHO fears the H1N1 virus, responsible for swine flu, could recur. Because of this possibility, pregnant women are being offered the vaccine for the first time.
The usual 'at-risk' groups are also eligible, including the over-65s and key workers such as NHS nurses and doctors, and adults and children with asthma, heart problems, diabetes, multiple sclerosis (MS), and kidney and liver disease.
The vaccine is designed to protect against the two major flu viruses: influenza types A and B. The A strain is usually the more severe and has subtypes such as avian and swine flu, while the B strain is far more common and relatively benign.
This year's vaccine includes protection against H1N1, as well as the H3N2 virus, a form of swine flu, and the B/Wisconsin/1/2010-like virus, which was the major cause of flu two years ago.
Despite the spin, take-up rates for the flu shot have remained stubbornly low. Nevertheless, rates in the UK are some of the highest in the developed world, with 74 per cent of the over-65s and 52 per cent of those in the 'at risk' groups having the vaccine, according to figures for the 2010/11 campaign (Department of Health. Seasonal influenza vaccine uptake amongst GP patient groups in England. Winter season 2011/12).
The figures are much lower in the US, where this year's adult takeup rate is just 46 per cent. The best takeup was among the over-65s, 71 per cent of whom have been vaccinated (Centres for Disease Control and Prevention; www.cdc.gov/flu/professionals/vaccination/nfs-survey-march2012.htm).
Among key healthcare workers such as doctors and nurses, last year's vaccine takeup was around 64 per cent vs 98 per cent when required by their employers (Centres for Disease Control and Prevention; www.cdc.gov/flu/healthcare workers.htm).
Perhaps to encourage a greater takeup rate, one Canadian scientist has surmised that the flu shot might prevent heart attack or stroke. Looking at a range of studies involving 3,227 patients, Dr Jacob Udell, a cardiologist at the University of Toronto, discovered that those who had been vaccinated were 50-per-cent less likely to suffer a major heart attack during the following 12 months.
However, as the intended benefit of the flu shot is not to reduce heart-attack risk, and there is no mechanism to demonstrate how it could have such an effect, the results appear to be a happy coincidence.
Dr Udell perhaps revealed the true purpose of his research when he said: "The use of the vaccine is still much too low . . . Imagine if this vaccine could also be a proven way to prevent heart disease." The takeup rate for the vaccine in Canada is around 36 per cent, similar to that in the US (Presented at the Canadian Cardiovascular Congress, October 27-31, 2012, Toronto, Canada).
Takeup this year has been affected by contaminated sup-plies. In the UK, 160,000 doses of the flu vaccine Agrippal, manu-factured by Novartis, were recalled after particles were found in the vials.
Seven other countries-Canada, Switzerland, Austria, Germany, Spain, Italy and France-banned Agrippal and Novartis's other flu vaccine, Fluad, after particles were also found in stocks. Novartis said the particles were protein particles and posed no health risk. The bans were lifted after several weeks.
Another flu vaccine used in the UK-Crucell's Inflexal V-was also withdrawn after there were signs of contamination in several of the batches sent to surgeries. Crucell supplies around 10 per cent of the flu vaccines used in the UK.
By 2014 at the latest, all children aged from two to 17 years will be offered an annual flu vaccine. The preferred vaccine is a nasal spray, Fluenz, manufactured by Astra-Zeneca, which has been used in the US for the past 10 years.
In all, around nine million UK children would be eligible for Fluenz, and the JCVI estimates that it could save 2,000 lives and prevent 11,000 hospitalizations every year. This is indeed a remarkable and worthwhile benefit-if only it were true.
According to America's Centers for Disease Control and Prev-ention (CDC), around 97 children under the age of 19 years die each year from flu symptoms. This is an average figure, and actual deaths each year ranged from a high of 234 deaths in 1977 and a low of 41 deaths in 1981-and these are deaths recorded in the US, which
has a population five times the size of the UK's. This average translates into 0.1 deaths per 100,000 people, so if there are nine million children in the UK who fall within the Fluenz target group, just nine could be expected to die from the flu in any given year. So where did the JCVI get its estimates from? Again, the same unpublished study prepared by the Health Protection Agency. Yet, according to the NHS, the JCVI carried out "a comprehensive review of the evidence" into Fluenz's efficacy and safety.
Aside from extensively reviewing just one unpublished study-which nobody else is allowed to see-the JCVI also ignored the guidance of the WHO, which concluded that the effectiveness of the nasal vaccine was very low.
The flu vaccine has a relatively good track record of safety, although the niggling side-effects-which are every bit as distressing as the flu itself-appear to be all too commonplace.
There's a more worrying concern, however: it doesn't work. But because people assume it does, they are doing very little themselves to improve their immune systems. As a result, they are left more open to other diseases too, some of which can be lethal in the elderly.
Instead of touting a vaccine that doesn't work, health regulators would do better by promoting personal responsibility for good health through an improved diet and lifestyle.
How to protect yourself
If the vaccines don't work, what can you do to protect yourself and your family-especially elderly relatives-from the seasonal flu? The key is prevention, of course, and that comes down to a healthy immune system. Here are some of the things you can start introducing into your daily life today.
u Exercise. Regular aerobic exercise is a good way to ward off colds and flu. People who do at least 20 minutes of moderate aerobic exercise-such as jogging, biking or swimming-on five or more days per week tend to suffer less from cold and flu symptoms than those who exercise just one day a week.
u Vitamin C. This antioxidant vitamin can significantly reduce cold or flu duration and severity (Cochrane Database Syst Rev, 2007; 3: CD000980).
u Zinc. If you act fast, taking zinc-as a lozenge, syrup or tablet-can reduce the duration and severity of a cold. The results of 13 trials, involving nearly 1000 people, showed that those who took zinc within 24 hours of their symptoms starting had shorter and milder colds than those who didn't take the mineral (Cochrane Database Syst Rev, 2011; 2: CD001364).
u Vitamin D. The 'sunshine vitamin' may be useful for reducing the risk of colds and flu. In a large-scale US study, people with the lowest levels of vitamin D reported having significantly more recent colds or bouts of flu. The risks were highest in those with chronic respiratory disorders, such as asthma and emphysema (Arch Intern Med, 2009; 169: 384-90).
u Nasal irrigation. Saline nasal irrigation (SNI), where a saltwater solution is used to flush out the nasal passages, could be a useful weapon against colds and flu. In a trial of 401 children with a cold or flu, the SNI users reported fewer illness days, school absences and complications compared with the medication-only group (Arch Otolaryngol Head Neck Surg, 2008; 134: 67-74).
u Probiotics. Taking doses of healthy bacteria through yoghurt and supplements was associated with 12-per-cent fewer acute upper respiratory tract infections (URTIs), such as colds and flu, compared with a placebo (Cochrane Database Syst Rev, 2011; 9: CD006895).
u Propolis. This gummy substance-collected by honeybees from leaf buds and tree bark-may be helpful for preventing colds and shortening their duration if you catch one (Rom J Virol, 1995; 46: 115-33).
u Stress reduction. Stress-management techniques, such as guided imagery, meditation and yoga, may be effective for reducing cold and flu symptoms (J Psychosom Res, 2001; 51: 369-77, 721-8).
u Heat. Taking regular saunas may cut your chances of catching a cold, an Austrian study suggests. Fifty volunteers were split into a sauna-bath group and a no-sauna control group. After six months, the sauna group had considerably fewer colds (Ann Med, 1990; 22: 225-7).
If you do get the flu, you can reduce its severity by trying these herbal remedies:
u Echinacea. Echinacea purpurea reduces cold symptoms and their duration, and appears to be effective for treating flu symptoms too. For best results, take Echinacea at the first signs of illness (J Altern Complement Med, 2000; 6: 327-34).
u Garlic. In a UK trial of 146 volunteers, one capsule per day of an allicin-containing garlic supplement led to 63-per-cent fewer colds and 70-per-cent fewer sick days compared with those taking a placebo (Adv Ther, 2001; 18: 189-93).
u Ginseng. In a randomized, double-blind placebo-controlled trial of 227 patients vaccinated against the flu, those who took 100 mg/day of a ginseng extract (Panax ginseng) for 12 weeks reduced their frequency of colds and flu while increasing their immune response (Drugs Exp Clin Res, 1996; 22: 65-72).
u Astragalus. This herb has traditionally been used as a tonic and treatment for colds and flu either alone or in combination with other herbs.
u Chinese herbals. The Chinese herbal remedy Ma Xing Shi Gan-Yin Qiao San, which is made up of 12 herbs, was more effective than Tamiflu (oseltamivir) at lowering febrile temperatures in people with the flu (Ann Intern Med, 2011; 155: 217-25).
A-tishoo of lies
Drug giant Roche makes lb1.9 billion a year from the sale of Tamiflu (oseltamivir), the world's major antidote to flu epidemics-but it's been hiding evidence that suggests the drug is not effective and could even damage the immune system.
While governments around the world have been stockpiling supplies of the antiviral to protect key workers, Roche has been concealing data about the drug's safety and effectiveness.
The evidence was released earlier this year only when the Cochrane Collaboration, an independent research group, resorted to freedom of information laws after Roche had refused its many requests for the data.
In the early exchanges, Roche had maintained that it was sitting on 10 unpublished trials that demonstrated Tamiflu's benefits. But once the data were finally released, the claims-together with others Roche had made, such as the drug had no adverse effects and did not damage the immune system-were proved to be false (Cochrane Database Syst Rev, 2012; 1: CD008965).
In fact, Tamiflu blocks the body's own natural defences against the flu virus and increases the risk of vomiting in children. It's also little better than a placebo, or sugar pill, at preventing flu or reducing the length of the illness, the suppressed data reveals.
Roche has a track record of hiding the truth about its drug. In 2003, the US drugs regulator, the Food and Drug Administration (FDA), forced Roche to tell doctors to stop prescribing the drug to children under the age of one year after independent research revealed its dangers to the very young. Then, in 2006, it had to admit that patients could cause harm to themselves by taking the drug.
Three years later and the FDA was back knocking at Roche's door. This time, Roche was told to announce that the hallucinations and abnormal behaviour associated with the drug could be so extreme that the patient might even commit suicide, as had already happened in Japan. The FDA told Roche to issue this latest warning after it had received numerous reports from worried doctors across the country.
South Korean health authorities issued a similar warning against the use of Tamiflu in 2007, and have completely banned its use among teenagers.
No such warning has been issued in the UK or any other European country, even though similar worrying side-effects have been seen among the UK's children. More than half the children given Tamiflu suffer from side-effects such as nightmares and nausea. The UK's Health Protection Agency has revealed that 53 per cent of children given the drug have reported one or more side-effects. The most common complaint was nausea, reported by 29 per cent of the children, followed by stomach pain and cramps, and sleeping problems. Around one in five also suffered from 'neuropsychiatric side-effect', such as nightmares or strange behaviour (Eurosurveillance, 2009; 14: pi=19287).
vol 23 no 9 December 2012