Flu Experts: Vaccine Effectiveness 'not demonstrated'

U.S. Experts Struggle with Flu Vaccine Questions
February 18, 2004

(original article here)

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - U.S. vaccine experts began meeting on Wednesday to formulate next winter's influenza vaccine, but said they had trouble deciding how well last year's formula worked.

Various studies show the vaccine had effectiveness ranging from none at all to 60 percent -- statistics that confounded experts trying to decide how best to protect the public from the highly contagious virus.

"It's hard to make sense of it," Dr. Bruce Gellin, director of the Health and Human Service Department's National Vaccine Program Office, told reporters.

"We really need to have a system in place year to year that tracks the efficacy of the vaccine."

Every year the flu vaccine is reformulated in an attempt to keep up with the quickly mutating virus, which kills an average of 36,000 Americans every year and 250,000 around the world.

Last year, U.S. government health officials and the companies that make the vaccine miscalculated, and failed to predict that a new strain called the Fujian influenza A strain would be the most common cause of infection. They left it out of the vaccine mix.

Fujian A hit Australia hard, and then showed up in the United States unusually early -- in October. It made headlines as it quickly killed several young children in Colorado.

Influenza eventually killed at least 111 children in 33 states before waning in recent weeks, the U.S. Centers for Disease Control and Prevention says.

NO COORDINATED INFORMATION

Knowing how well past vaccines have worked is useful for deciding how to formulate future vaccines, but Gellin said there is no coordinated system for doing so. He said the National Vaccine Advisory Committee had been asked to come up with a better system.

Meanwhile the Food and Drug Administration is expected to approve the flu mix suggested earlier this month by the World Health Organization. The FDA committee will make its recommendations on Thursday.

Under WHO recommendations, the Fujian strain -- which caused more than 90 percent of confirmed influenza cases in the United States and Northern Europe -- will be added to the mix.

A strain known as Moscow A will be taken out.

The mix is also likely to replace the influenza B Hong Kong strain with one called Shanghai B strain, even though influenza B strains caused fewer than 10 percent of infections.

And a strain called New Caledonia, another influenza A virus, will stay in the mix.

Determining the mix is an imprecise science, as demonstrated by studies presented to the FDA's vaccine advisory committee.

"We were unable to demonstrate vaccine effectiveness against influenza-like illness," said the CDC's Dr. Carolyn Bridges, who studied how well the vaccine worked.

And Dr. Antoine Flahault of the French national research institute INSERM said his study of people vaccinated in France showed the same flu vaccine as was used in the United States was 60 percent effective.

"The problem with influenza-like illness studies is that there are a lot of things that are influenza-like," Gellin said. He said unless patients are tested to confirm they have influenza, they could have a range of respiratory diseases, none of which a flu vaccine could be expected to prevent.

Dr. Arnold Monto of the University of Michigan said the vaccine studies may be examining too broad a range of people. The symptoms of "influenza-like illness" includes fever, sore throat and a cough.

See related:

Flu shots - how useful are they?

The Fujian virus - promoting flu vaccines

Ninety-three Children Dead of Flu - Majority were vaccinated!

The Avian Flu and Drugless Doctors

Book: Wake Up To Health In The 21st Century

There have been many instances over recent years that show quite clearly just how adept our governments and media outlets are at creating mass anxiety over even the slightest of diseases. With the news that UK supermarket Asda (Walmart subsidiary) is now offering the flu jab on-site to its customers (at the bargain price of £11.97 as opposed to the normal £20.00), readers are strongly encouraged to acquaint themselves with the tawdry, unethical nature of today's so-called flu protection programmes, before rolling up their sleeves AAARGH! FLU! BUT IS IT SUCH A DREADED DISEASE? We can all remember the headlines over the last few winters: Killer Flu On The Way! New Super Flu Heading for the UK. Britain Braces Itself for an Epidemic. For several years now, every UK newspaper at one time or another has led with graphic accounts of a flu plague threatening to engulf Britain. Take this frenzied headline from The Sunday Mirror, as far back as the 28th September, 1997:

MILLIONS AT RISK FROM KILLER FLU - Doctors are preparing for a massive outbreak of killer flu this winter. Millions of people are expected to die worldwide as a new strain of super-bug sweeps the globe. And with 10 million people in a high-risk category in Britain, the Government has already alerted hospitals - and mortuaries - to the threat. A detailed document sets out how the health service will cope with large numbers of people ill and dying and includes mortuary arrangements for a large number of deaths.

And the result? No flu pandemic. In fact, no flu pandemic anywhere. The lack of any flu plague across the globe did not bring a halt to those killer flu front page specials. With boring monotony, the winters of 1998, 99, 2000, 01, 02, 03, saw the same, tired old headlines appearing in the press. And now (December 2003), these inane headlines are still with us. Take the following health scoop from USA Today, dated December 3rd 2003: The warning sirens are screaming: A deadly, contagious strain of flu will emerge, possibly soon, flu experts say, and the world is not ready to deal with it. "The world will be in deep trouble if the impending influenza pandemic strikes this week, this month, or even this year," write international flu experts Richard Webby and Robert Webster of St. Jude Children's Research Hospital in Memphis.

And this latest from the UK Daily Express, dated 23rd October 2003: Killer flu hits Britain. Alarmed Health experts warned all doctors that high-risk categories - the elderly and those with heart problems - should be vaccinated. The mutant virus has swept through Australia where it is blamed for thousands of deaths in the worst flu outbreak for five years.

But with no flu outbreaks ever emerging and the death rates in these stories, as we shall discover, always wildly exaggerated, just where were all these headlines coming from? Credence Publications has been following the flu headlines for a number of years now. Predictably, these flu editorials have been nothing more than a pharmaceutical sales pitch. In short, they are a complete scam. It was the following report from the BBC, that prompted our initial investigation into the matter:

"The number of those catching the flu bug has risen by more than 80% in just seven days and hospitals and ambulance services are bracing themselves for a further tide of emergency admissions and deaths. Provisional figures released on Wednesday by the Royal College of General Practitioners (RCGP) showed the first large rise in cases in the south as the virus spreads from the North and the Midlands. As the Emergency Bed Service issued a warning that hospitals may run out of beds, it emerged on Wednesday that a second Norfolk hospital is using a refrigerated lorry trailer to act as a standby mortuary." [1]

HARDLY AN EPIDEMIC

Great mileage was made of the death of 33-year-old UK rugby player Kieron Gregory, and of Nigel Tranter, one of Britain's most prolific authors, who succumbed to the deadly plague at aged 90![2] But these star deaths were about the only tragedies the media could muster. Hardly an epidemic.

In another desperate bid to report on something compellingly flu-oriented, one BBC Evening News item featured a roving reporter giving a live update from Scotland's flu outbreak epicentre. The camera panned across a hospital ward containing seven beds, in which lay seven persons all over the age of 65, all suffering from -- mid-January FLU! And of course, because of their age, all these seven people fell comfortably within the risk group associated with contracting flu anyway. Hardly award-winning material. And throughout the whole flu campaign, this was the most earth-shattering evidence the BBC could muster to support the wild headlines engulfing the nation.[3]

But amidst all the hype and the push to inoculate, inoculate, inoculate! the body count for flu deaths, both in the UK and the US, remained normal. Apart from those people within the traditional risk group associated with flu fatalities, i.e., the elderly and infirm, who actually knows anyone who died of the illness? What was driving all this factually bankrupt editorial?

WHEELS WITHIN WHEELS

A clue might well come from the fact that, running alongside our five winters' worth of killer flu headlines, the immensely powerful pharmaceutical corporation Glaxo Wellcome PLC (now Glaxo SmithKline) had been hard at work developing and marketing its new super flu drug Zanamivir (Relenza). When it comes to Glaxo's marketing campaigns, no stone is left unturned, no expense is spared.[4] Relenza had been granted US and European marketing licences, but it was now time to release the drug onto the UK market. And that's when the UK arm of the mighty Glaxo machine ran into difficulties, albeit temporarily.

The product was initially denied a supply licence to the UK National Health Service by NICE - the National Institute for Clinical Excellence - an organisation set up supposedly to safeguard the public from rogue operators and rogue pharmaceutical treatments. NICE claimed that too few high-risk positive responders were represented in the Glaxo trial results for Relenza. Tactfully, they were saying there was no proven efficacy. This wasn't helped by the admission at a press conference from Glaxo's Respiratory Associate Medical Director, Dr Robert Pearson, that "we can't make any claims for its use in high risk groups." [5]

Sir Richard Sykes, former chairman of Glaxo Wellcome, immediately went to the media. In a letter to then Health Secretary Frank Dobson, copied to Prime Minister Tony Blair, and leaked to (or should we say judiciously positioned in) the Sunday Telegraph, Sir Richard said the decision represented a "... very serious threat to the future of one of the UK's most successful international industries." He further wrote: "The UK can no longer be seen as providing a suitable market for the early launch of innovative new medicines. This will have a severe impact on three UK-based multinational companies and calls into question the suitability of the UK as a base for multinational pharmaceutical companies." [6]

Let's be quite clear about this. The contents of corporate letters of complaint are not displayed prominently in broadsheet newspapers without that corporation having considerable influence at the editorial level. This considerable influence is also able to open doors to national TV and radio, allowing a full and public airing of commercial grievances.

On Monday, 4th October 1999, Sykes was interviewed on BBC Radio Four's Today program. He predicted that the British pharmaceutical industry would start to move out of Britain if the government made the environment antagonistic to its interests. He further told the program: "The British drugs industry is one of the finest examples of a technological industry in Britain that has actually made it in global terms. I am saying to the Government: please understand that if you continue to make an adverse environment for pharmaceutical companies, then obviously by definition they will start to move elsewhere."

On Tuesday, 5th October, another huge pharmaceutical conglomerate, AstraZeneca, joined Glaxo Wellcome in writing to Prime Minister Tony Blair, repeating the warning that the industry could suffer and many UK jobs could be threatened if doctors were barred from prescribing Relenza.

AND THE OUTCOME OF THIS FLURRY OF ACTIVITY?

A couple of days‚ pressure on Prime Minister Blair from those who really call the shots, along with some judiciously placed news items featuring pensioners clamouring "...our prospects are grim unless Glaxo's marvellous new flu drug is made available"[7] and, Hey Presto! Relenza now enjoys the status of a full UK marketing licence.

As a result of all of this favours for favours string-pulling, taxpayers are now paying millions of pounds annually for a drug which has absolutely no proven efficacy, according to regulators, and is directly linked to numerous deaths in the US, as reported by WebMD.[8] Dr. William Campbell Douglass, editor of Second Opinion newsletter, reports that in the US, the Food and Drug Administration approved Relenza "...even though it doesn't work." Dr. Douglass said the FDA ignored the recommendations of its own advisory panel, which voted 13-4 against approving Relenza. Says Douglass, "Relenza is a medical swindle." Dr. Sidney Wolfe of the Public Citizen Health Research Group stated: "This drug should never have been approved. The benefits are close to zero." [9] As a statutory obligation on behalf of the manufacturers, Relenza has a warning leaflet inserted in each prescription, stating that lung damage from the inhaled powder is not impossible.[10]

In a CBS Special, entitled "Anti-flu Drug May Be Deadly", reporter Sharyl Atkinson announced, "When Relenza hit the market last flu season, it was aggressively marketed by Glaxo Welcome as an exciting new treatment. The company claimed the inhalant attacked a type of flu immune to older drugs. The ads were flashy, but the medical claim was more modest - to get rid of the flu one day faster..."

UNBOUGHT MEDICAL OPINION HARD TO FIND

In a recent interview with The Nation magazine, best-selling author John Le Carré stated:

"Big Pharma [the industry in general] is engaged in the deliberate seduction of the medical profession, country by country, worldwide. It is spending a fortune on influencing, hiring and purchasing academic judgment to a point where, in a few years' time, if Big Pharma continues unchecked on its present happy path, unbought medical opinion will be hard to find." [11]

And true to form, the NICE policy on Relenza has now been redrafted. It seems they have been bought out, morally and intellectually, over this issue. The decision is no longer "Do we approve this drug?" but "Despite the dangers, how do we approve it?"

A COMPLETE FAILURE

Doctors are now regularly offered thirty pieces of silver bonuses to encourage patients into trials of newer, more sparkly drugs. Says Ismail Shalaby, chief executive of US-based Nema Medical Research Inc., "There are physicians who can now net about $500,000 to $1 million a year doing clinical research. That's not bad." [12] Dr Michael Elashoff, a former drug evaluator at the FDA (accent on the word former), made the mistake of questioning the efficacy of Relenza. After painstakingly observing no difference between the groups monitored, Elashoff concluded that Relenza was "a complete failure." Very soon after, it was suggested that it would probably be better if he left the division. Despite the warnings from Elashoff and others, Relenza continues to be sold and has since been linked to numerous bronchio-spasm deaths in the US, leading to a world-wide warning letter being issued by GSK advising certain groups against inhaling the powder.[13]

When it comes to the flu vaccine, The Vaccine Risk Awareness Network has this to say:

"The most intriguing deception of the public, however, is the suggestion that the patient who gets an influenza vaccination will not get the flu. What is generally known to the public as a flu is an influenza-like syndrome, with symptoms like fever, chills, muscle or joint pains, a headache, a runny nose, and general malaise. This disease, however, has got nothing to do with the real influenza, neither can it in any way be prevented by an influenza vaccination. Thus, if doctors guarantee their patients that they will not get the flu after they came in to get their jab, this is an unethical manipulation, the basis for which most probably is simply profit for both those who produce the vaccine and those who administer it." [14]

The same article cites a home for elderly people, where, despite the fact that two thirds of the population had been vaccinated, a severe flu struck 49% of them, causing considerable ill-health and a 10% death-rate. An important observation was that in the vaccinated population, 50% got the disease, compared to 48% of the non-vaccinated.[15]

When we step back a pace or two from this whole sorry saga, we realise that all of this £multi-million wrangling has taken place over an illness that a reasonably strong constitution can shake off unaided in a matter of days anyway (collective inward gasp). Is that such an outrageous statement? Has the I must have my flu-shot brainwashing worked to such an extent that these words seem shocking? The USA Today report included at the beginning of this story continues: Webster and Webby argue that new methods to produce flu vaccines rapidly are known, but have not yet been tested. "What's necessary is to do trial runs and demonstrate these new vaccines are safe," Webster said during a press briefing. Also needed is a stockpile of anti-viral drugs that can be used to treat or prevent the spread of flu. Current supplies would last only days in a pandemic, Webster said, "but no country has yet invested in stockpiling."

And the Daily Express flu feature has Professor John Oxford, urging people to go for their flu vaccine, saying, "It is better to be careful and be prepared".

THE 1918 KILLER FLU EPIDEMIC

The following text is taken from a conventional medical introduction to the Great Flu:

"The influenza pandemic of 1918-1919 killed more people than the Great War, known today as World War I (WWI), at somewhere between 20 and 40 million people. It has been cited as the most devastating epidemic in recorded world history. More people died of influenza in a single year than in four years of the Black Death Bubonic Plague from 1347 to 1351. Known as Spanish Flu or La Grippe‚ the influenza of 1918-1919 was a global disaster." [16]

These are impressive statistics and on the face of it, seemingly inarguable. However, a little further down in the same article, reference is made to the intervention of the vaccinators - the absolute key to understanding this particular epidemic:

"The war also gave science greater importance as governments relied on scientists, now armed with the new germ theory [examined in a later chapter] and the development of antiseptic surgery, to design vaccines and reduce mortalities of disease and battle wounds. Their new technologies could preserve the men on the front and ultimately save the world." [17]

Throughout the First World War, many vaccines were given to the troops. But because the war only lasted four years, the vaccine-makers were unable to use up all their vaccines. As they were (and still are) in business for profit, they decided to sell the vaccines to the rest of the population. Once again, a scare-tactics, mass-advertisement campaign was implemented. There were no epidemics to justify mass-vaccination, so they used other tricks. Their propaganda claimed the soldiers were coming home from foreign countries with all kinds of diseases and that everyone must have all the shots on the market. Vaccine historian Eleanor McBean takes up the story:

"The people believed them because, first of all, they wanted to believe their doctors, and second, the returning soldiers certainly had been sick. They didn't know it was from doctor-made vaccine diseases, as the army doctors don't tell them things like that. Many of the returned soldiers were disabled for life by these drug-induced diseases. Many were insane from post-vaccinal encephalitis, but the doctors called it shell-shock, even though many had never left American soil.

That pandemic dragged on for two years, kept alive with the addition of more poison drugs administered by the doctors who tried to suppress the symptoms. As far as I could find out, the flu hit only the vaccinated. Those who had refused the shots escaped the flu. My family had refused all the vaccinations so we remained well all the time.

It has been said that the 1918 flu epidemic killed 20,000,000 people throughout the world. But, actually, the doctors killed them with their crude and deadly treatments and drugs. This is a harsh accusation but is nevertheless true, judging by the success of the drugless doctors in comparison with that of the medical doctors." [18]

BEWARE OF HENRY'S JAB!

Contextualising the flu debate, two issues emerge: one, there is a great deal of money being made out of flu vaccines and other flu medicines. And two, this illness is not generally the killer it is being made out to be. Any disease or illness will always have its percentage of fatalities. But those fatalities are almost always in the minority and, again, almost always dependant upon the health of the host at the time. Rest assured, a well-nourished immune system combined with a good understanding of the dangers of vaccination and associated toxic pharmaceuticals AND AVOIDING THEM, can only guard us against many future ills.

In the UK, boxing legend Henry Cooper (the only man to have floored Mohammed Ali - a knockout denied by the bell) is fronting the UK National Health Services flu vaccine campaign. "Do yourselves a favour," says the strapping Henry, "Go get vaccinated." What on earth is the super-fit Henry doing? There is more than ample evidence to demonstrate that concentrating on optimum nutrition will aid us in protection and/or swift recovery from many of these illnesses.

Steven Ransom

Excerpted from Wake Up To Health In The 21st Century,

Credence Publications

www.credence.org

Comments to steve1@onetel.net.uk

[1] Flu reaching a peak‚ BBC News, 7th January 1999

[2] LineOne News, 10th January 2000

[3] BBC Evening News, 11th January 1999

[4] Foss, Krista, Debate raging in medical community over pharmaceutical marketing practices

"A year ago, when a pharmaceutical firm offered the hospital's 10 cardiology residents a refrigerator for their lounge if they watched a video about a drug, he finally got his colleagues to say no, too..." See also in same paper "Last year, Glaxo Wellcome PLC, which makes the newly approved drug for treating influenza, Relenza, flew Dr. Barron to Montreal from Vancouver for a day of work. In addition to paying for his flight, overnight stay and meals, the company gave him $1,500." "I was under the impression I was taking part in developing influenza education for Quebec's licensing authority for doctors," he said. "As it turned out, I was being asked to design an educational presentation for Relenza. I was uncomfortable and wouldn't do it again."

[5] British Medical Journal, 9th October 1999; 319:942

[6] Sunday Telegraph, 3rd October 1999

[7] "Give us wonder flu drug. Elderly fear Dobson may ban Relenza because of the cost. LineOne News, 2nd October 1999

[8] Relenza Linked to Patient Deaths in Some Cases, Says Maker

[9]  Byrnes, Stephen, The Truth about Relenza‚ Health on the Edge, 1st July 2001

10] The U.S. Food and Drug Administration has told GlaxoSmithKline to strengthen warning labels on its flu drug Relenza, following serious breathing problems which may be linked to the drug, officials said on Wednesday

[11] Interview with John Le Carré‚ The Nation, 9th April 2001

[12] Drug Trials Hide Conflicts for Doctors‚ New York Times, 16th January 2001

[13] Byrnes, Stephen, The Truth about Relenza, op. cit.

[14] The Influenza Vaccine

[15] ibid.

[16] Billings, Molly, The Influenza Pandemic of 1918, Stanford Education Dept, June 1997, at

[17] ibid.

[18] McBean, Eleanor, Swine Flu Expose, August 1977, online books