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23 Mar 2010

The great swine flu swindle?

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A pandemic of devastating proportions it was to cause a global standstill as millions of people around the world died and millions more got sick. So what happened to swine flu? NGH investigates why something predicted to cause so much chaos proved to be a relatively harmless strain of flu.

“The WHO basically held a trigger for the implementation of the pandemic preparedness plans and with this high revenues for the involved producers of pandemic vaccines and some antiviral drugs”
-Dr Wodarg Wolfgang

It was almost exactly a year ago that an outbreak of H1N1, or swine flu, began in the state of Verccruz in Mexico. There was evidence that there had been an ongoing epidemic for months before it was officially recognised as such and the Mexican government closed most of Mexico City's public and private facilities in an attempt to contain the spread of the virus. Unfortunately, it spread globally as clinics became overwhelmed with infected patients. In fact the World Health Organization (WHO) and the US Centers for Disease Control (CDC) stopped counting cases over the coming months and in June declared the outbreak of a pandemic.

The initial outbreak was at the centre of a week-long near-constant media focus on the condition as death on a mass scale was predicted. Over one billion people around the world were predicted to fall victim to the disease with millions getting sick as parallels were drawn with the Spanish Influenza of 1918 in which 40 million people died in 18 months. In Britain alone health authorities' worst-case scenarios predicted as many as 65,000 people could die over the winter season, while Germany ordered 50 million doses of the vaccine and the Netherlands 34 million. Meanwhile France and Portugal announced major orders for vaccines against the virus, soon after Latin American countries expressed concern that their poorer regions could miss out.

Films like Danny Boyle's 28 Days Later suddenly became a daunting reality as people around the world were convinced a devastating plague was on its way: trade was predicted to slow to a crawl, economies were sure to crumble, schools would be empty, food supplies would dwindle and power supplies were going down.

But by March 2010, swine flu had claimed 16,713 lives - nowhere near the millions suggested - which barely registers on the annual death toll from seasonal flu, estimated at between 250,000-500,000. So just what happened to swine flu? Scientists claim that while the virus is mild, it can still kill - and in fact is still responsible for deaths - however, the low fatalities are down to the fast-acting response to official advice.

Fred Hayden, influenza research coordinator at the Wellcome Trust and a former WHO expert, told Reuters back in November 2009 that early planning paid off because the original predictions had been revised, adding, "I wouldn't characterise this as a 'mild' pandemic at all - we are seeing some very unfortunate loss of life. I think it's a bit early to make that judgement."

A cautionary tale

Five months later and after the dreaded flu season in Europe has passed it seems Hayden could be wrong in his evaluation and that the pandemic is indeed 'mild', particularly as it has been used so frequently to describe a patients condition. Accusations were flying as early as October and November last year when both British and French media suggested that the pandemic had been 'hyped'. Sceptics across the continent are asking what are the hype was all about - in November for example, France's Le Parisien newspaper ran the headline 'Swine flu: why the French distrust the vaccine', and noted that "Dangerous liaisons between certain experts, the labs and the government, with the obscurity of the contracts between the state and the pharma firms adding to the doubt."

Scientists claim they are stuck in the middle and can't win, that they were unable to avoid the advice from organisations like WHO, because it would have caused public outrage and widespread panic to simply ignore the global guidelines. And it appears that the WHO has yet to learn its lesson - indeed, the organisation has been urging countries to prepare for a flu pandemic since 1997, when H5N1 (avian flu) infected 18 people in Hong Kong and the re-emergence of the infection occurred in China and South Korea in 2003.

Mike Fumento, a writer and blogger based in the US, undoubtedly believes that the hype is all down to the way WHO have dealt with the situation, particularly in the way it dealt with changing the definition of 'pandemic', which occurred just before swine flu was announced as such. "The definition previously required 'enormous numbers of deaths', but the agency desperately wanted a pandemic and with swine flu vastly milder than ordinary flu, it clearly didn't fit. So they simply penned a new definition to match swine flu, making deaths irrelevant and explicitly declaring 'mild' strains would qualify," says Fumento. "However, the change cannot be justified medically - a flu pandemic simply has to include severity or it's meaningless, which is unlike non-flu or other virus pandemics, because flu hits almost every single country around the globe every single year."

Fumento goes on to explain that because the WHO described swine flu as a pandemic, the media jumped on the story focusing on the fact that this was the first pandemic in 41 years and therefore putting it in the same category as the Spanish Flu and the Asian Flu. Experts like John M. Barry wrote a piece for influential newspaper The Washington Post claiming that because it is a pandemic the US alone could expect between 89,000 to 279,000 deaths. And rather than look at the severity of the infection, Fumento proposes that figures were extrapolated from the last pandemic in 1957/58, which makes the data meaningless when the mildness of the infection is taken into account.

Tom Jefferson, a physician and epidemiologist for the last 15 years conducting extensive reviews of seasonal influenza vaccines, believes that one of the extraordinary features of the whole influenza saga is that there are people who make predictions year after year, seeing it getting worse and worse. "Sometimes you get the feeling that there is a whole industry almost waiting for a pandemic to occur," says Jefferson. "The WHO and public officials, virologists and the pharmaceutical companies - they've built this machine around the impending pandemic. And there's a lot of money involved, and influence and careers, and entire institutions. And all it took was one of these influenza viruses to mutate to start the machine grinding."

Jefferson goes on to explain that influenza is a big money maker for the pharma companies, because of the vaccines and drugs that are sold to combat it. He says that the strict focus on flu is not only misguided, but extremely dangerous. Indeed, many cynics are pointing the finger at pharmaceutical companies as being the mastermind behind the swine flu pandemic. It doesn't help matters that in the US, for example, the government has decided to make sure that the pharmaceutical companies producing vaccines are protected from legal action by any patients who suffer from adverse affects of the vaccines such as pain, suffering or death should it occur. Secretary of Health and Human Services Kathleen Sebelius signed a document back in June 2009, granting immunity to those making swine flu vaccines under the provisions of a 2006 law for public health emergencies that allows for a compensation fund if needed. Federal officials will also be immune from lawsuits, conveniently granting themselves impunity from their actions.

Unfortunately for the public, vaccines have been rushed to market before many of the tests to discover potential side effects become known, which could prove extremely dangerous as proved back in February 1976, when an outbreak of swine flu struck Fort Dix army base, New Jersey in the US, killing a 19-year-old and infecting hundreds of soldiers. President Gerald Ford, believing the US was on the brink of a devastating epidemic ordered a nationwide vaccination programme at a cost of US$135 million. Within a month, reports of Guillain-Barre syndrome - a paralysing nerve disease - surfaced and by April more than 30 people had died of the crippling condition. Facing protests, federal officials abruptly halted, and then cancelled, the vaccination programme in December of that year. The swine flu epidemic failed to materialise.

This all rings true of the past year. And in fact the WHO is currently defending itself against charges from the Parliamentary Assembly of the Council of Europe (PACE) in relation to the pandemic. Dr Wolfgang Wodarg, Head of Health for the Council, has accused the makers of flu drugs and vaccines of influencing the WHO's decision to declare a pandemic, claiming that pharmaceutical companies made "enormous" gains, while countries around the world "squandered" their health budgets and saw millions vaccinated against a relatively mild disease. Wodarg branded the swine flu outbreak as "one of the greatest medical scandals of the century", adding that the seeds of the scare were thrown five years ago when it was thought the lethal bird flu virus would mutate into a human form.

"Associated Press reported on May 19, 2009, that China, Britain, Japan and a dozen other countries had urged the WHO not to use the proposed new definition of a 'pandemic' and to 'be very cautious about declaring the arrival of a swine flu pandemic', fearing that a premature announcement could cause worldwide panic and confusion," says Wodarg in the hearing on the handling of the H1N1 pandemic on 26th January 2010. He goes on to explain that there were already doubts over the WHO's alarm on avian flu in 2005/2006, which in fact was never transmitted between humans. Given that the WHO officially stated in panic-stricken terms that avian flu could threaten mankind it was unsurprising that medication worth billions of dollars was bought up quickly. "From a scientific view, this medication had never been clinically tested for the disease for which it was marketed, given that the avian flu had never become contagious among human beings and thus those medicines could not be tested because the disease they should be provided for did not exist."

As a consequence of the avian flu situation, contracts between national states and pharmaceutical manufacturers were signed in order to ensure that there would be a certain availability of vaccines in case of a real future pandemic. "These contracts and marketing commitments were to take effect when a global flu pandemic was declared by the WHO," says Wodarg. "So the WHO basically held a trigger for the implementation of the pandemic preparedness plans and with this high revenues for the involved producers of pandemic vaccines and some antiviral drugs." Wodarg reveals that the contracts signed between states and pharmaceutical companies were, for the majority, kept secret until some were recently made public by whistleblowers.

"We can see that the WHO undertook an incomprehensible action, which up to now was never justified by any scientific evidence. WHO 'gambled away' public confidence. It does therefore seem right that we investigate this matter within the Council of Europe to find out how the WHO could undertake such risky action in spite of lots of warning and protest from scientists and national governments. It did so in the case of the avian flu and again for the swine flu," says Wodarg. "The main questions to investigate are: Why has this been done, who is behind this, what is the core of this public-private-partnership which was introduced ten years ago, what is the role of the enterprises, who participates in relevant decision-making processes and who takes the overall responsibility?"

At the same hearing back in January, Dr Keiji Fukuda, Special Advisor on Pandemic Influenza to the Director-General at the WHO admitted that there is still much to learn about flu to improve the handling of such events, mainly due to the fact that it has been impossible historically to predict how an influenza pandemic's impact. He explains that swine flu spread with unprecedented speed, reaching 120 countries and territories in about eight weeks and that it also occurred outside the usual season for influenza causing a striking and unusual pattern of severe illness and death in younger people.

Regarding the accusations from PACE, Fukada says that the WHO takes the issue of providing independent advice very seriously. "The flu pandemic policies and responses were not improperly influenced by the pharmaceutical industry. Cooperation with a range of partners, including the private sector, is necessary, but numerous safeguards are in place to avoid conflict of interest. WHO is confident of the scientific validity of it recommendations. The labelling of the pandemic as 'fake' is to ignore recent history and science and to trivialise the deaths of over 14,000 people and the many additional serious illnesses experienced by others."

Meanwhile, Luc Hessel, Chairperson of the Pandemic Influenza working group for the European Vaccine Manufacturers rejects the fake pandemic motion, claiming that the vaccine industry did what it was asked to for which was to produce safe vaccines in a timely manner and respond to government requests. He says that the industry is governed by stringent health regulations and rigorous safeguards against conflict of interest. "The industry responded quickly and effectively and was able to deliver the vaccines ordered by governments.

"Our industry responded to requests from WHO and governments who wanted to have fast access to a large quantity of vaccines - it's too early to speculate on the overall return for the industry, but in my view the industry has been a responsible and reliable partner. Pandemic vaccines were properly tested and for the first time in history, vaccines were available shortly after the declaration of a pandemic - this was only possible thanks to a decade of research and development and 60 years of experience."

However, the vaccine makers profit margins speak for themselves: producers such as GlaxoSmithKline saw their profit margins soar by 30 percent during 2009 and Roche made a whopping 12 times its profit during the second quarter of 2009 compared to the same period in 2008.

Admittedly, hindsight is a wonderful thing - it's easy to be wise after the event - but the fact remains that there is a lot of unused swine flu vaccine - the UK government for example ordered 90 million doses of the H1N1 vaccine, with an option to buy 30 million more and only around 5.25 million people were vaccinated in Britain, and if this situation has occurred in other countries it's likely there are tens of millions of doses going spare around the world. And unless there is a fresh pandemic in the next couple of years, these are likely to pass their sell-by date.

Whether the swine flu epidemic was exaggerated in order to boost the bottom line of the big pharmaceutical companies or the WHO was justified in being cautious - despite changing the definition of a pandemic to fit with swine flu situation - is yet to be seen. With the PACE report on the poor practice of the WHO not due until the end of April - with a possible plenary debate in June - it's impossible to say where the finger of blame will point just yet.


Spot the difference

Original definition of a pandemic, according to the WHO: An influenza pandemic is a worldwide epidemic caused by a new strain of virus which leads to infection rates and mortality rates which exceed seasonal but similarly heavy waves of influenza by several orders of magnitude. A precondition for an influenza pandemic is the appearance of a viral subtype which had not yet circulated amongst the human population or which had occurred so long ago that no residual immunity remains amongst the population, and which is capable of provoking severe illness and of disseminating effectively from one human to another

New definition of a pandemic, according to the WHO: influenza pandemic may occur when a new influenza virus appears against which the human population has no immunity. WHO has defined the phases of a pandemic to provide a global framework to aid countries in pandemic preparedness and response planning. Pandemics can be either mild or severe in the illness and death they cause, and the severity of a pandemic can change over the course of that pandemic.


Timeline: The outbreak

March 2009: First swine flu infection
April 17, 2009:
A high-tech laboratory at the Centers for Disease Control identifies a new influenza virus
April 27, 2009:
The WHO raises its pandemic warning to phase 4, meaning it has discovered human-to-human transmission of the virus in at least one country
April 30, 2009:
Egypt begins killing all domestic pigs in the country, despite protests from animal rights activist and French actress Brigette Bardot to stop the mass slaughter
June 11, 2009:
The WHO declares a swine flu pandemic
July 24, 2009:
German states order 50 million vials of swine flu vaccine
August 2009:
By the end of the southern winter, fewer people than usual have died for an average flu season
November 2009:
Poland decides not to buy any vaccine
February 11, 2010:
The National Pandemic Flu Service in England is closed

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