Human Swine Flu A(H1N1) - Swine Flu Vaccines and Anti-Virals

Swine flu: How did we do?

This blog is no longer called Fergus on Flu, but I'm still happy to talk about pandemics.

Boiling down nearly 200 pages to two words, the Hine review's verdict on the UK response to H1N1 can be summed up as "highly satisfactory". Dame Deidre Hine repeatedly praises the planning and the response to the pandemic last year.

That said, there is a series of lessons to be learned, in particular about contract negotiations with vaccine manufacturers. She says the failure, in 2007, to negotiate get-out clauses in the vaccine contract "exposed the Exchequer to some risk". In other words, it cost the tax-payer money and we were left with lots of unused doses of vaccine. What Dame Deirdre does not tell us, because of commercial confidentiality, is how much that cost us.

Before condemning ministers and officials for poor planning, it's worth pointing out that no country in the world managed to negotiate a break clause with GlaxoSmithKline for its Pandemrix H1N1 vaccine.

Furthermore, had the pandemic been as bad as everyone originally feared, those extra doses of vaccine might have saved tens of thousands of lives.

Once last point. Given how mild the H1N1 pandemic was, how on earth are health officials and virologists ever going to interest the public in the potential dangers of the next pandemic? The next one may be a lot more serious.

Welcome to Fergus's Medical Files

A blog is re-born. Thanks to all of you who followed Fergus on Flu; I hope you will continue with the blog in its new form.

So what will you find here? As well as original posts, I hope to give some greater detail and insights into the stories I am working on elsewhere. My role is pretty broad: to look at medical research, ethics, global disease threats and more.

The blog will also provide a discussion point for these issues and I hope you will get involved. As I made clear in the past, I am not a scientist or a doctor, but a journalist. My role is to interpret often complex scientific information and relay it to a largely lay audience. If you should find any glaring errors, I'll do my best to correct them as soon as possible.

Letters: Scientific advice and common sense

You highlight a problem with scientific advice given by scientists with potential conflicts of interest (Report condemns swine flu experts' ties to big pharma, 4 June). Unfortunately, this is only the tip of an iceberg and reflects only one aspect of the problem with blind acceptance of scientific advice. Scientists are human beings and are driven by the same selfish desires as the rest of us. The altruistic scientist, driven only by "the search for truth", is a media fabrication. Fame and influence inflate egos. Hubris, arrogance and a woeful lack of self-awareness is common, in both scientific and medical communities.

In my experience many scientists cannot see beyond their limited horizons and only the most remarkable individuals are able to see the big picture. Wide-ranging controversies – such as the MMR scare, withholding of climate change data and the recent overreaction to the swine flu pandemic – show how powerful scientific evidence can be. This is neither intended to negate scientists nor scientific endeavour, but merely remind us that scientific advice must be tempered by a strong dose of common sense before public policy is altered.

Dr Tariq Ali

Oxford

• Marilynne Robinson (Mind over matter, Review, 5 June) offers a refreshing view that challenges the accepted dogma of neo-Darwinists and other scientific reductionists that the mysteries of nature have been sorted out through the application of unbiased science. They will have us believe that, given enough time, the chaotic laws of nature plus the simple mechanics of biological evolution explain everything.

An alternative possible scenario is that matter at its deepest level is characterised by: (a) a quality of "interconnectedness" or very primitive "mentality"; and (b) a natural law that drives matter towards complexity. Quantum theory provides evidence that supports premise (a). The evolution of matter, from the simple elements after the big bang to the complex elements of the periodic table, many of which are necessary as a basis for the biological evolution, which is also a manifestation of this general principle, provide evidence for premise (b). Both premises explain the gradual flowering of mentality from these simple elements that possess it in a most primitive and dilute form to that of the earliest micro-organisms capable of some overt communication and finally to us humans. There is no point of discontinuity at which suddenly the property of mentality emerged, just a sustained increase in material and mental complexity. Ergo, matter and mind are irrevocably entangled.

I am sorry to say that many scientists at present, contrary to the basic premise of science that all scientific explanations are temporary, proclaim views that they consider unshakable.

Professor Leon Freris

Radlett, Hertfordshire

MMRSwine fluMarilynne RobinsonPsychologyEvolutionPhysics

Report condemns swine flu experts' ties to big pharma

Trio of scientists who urged stockpiling had previously been paid, says report

Scientists who drew up the key World Health Organisation guidelines advising governments to stockpile drugs in the event of a flu pandemic had previously been paid by drug companies which stood to profit, according to a report out today.

An investigation by the British Medical Journal and the Bureau of Investigative Journalism, the not-for-profit reporting unit, shows that WHO guidance issued in 2004 was authored by three scientists who had previously received payment for other work from Roche, which makes Tamiflu, and GlaxoSmithKline (GSK), manufacturer of Relenza.

City analysts say that pharmaceutical companies banked more than $7bn (£4.8bn) as governments stockpiled drugs. The issue of transparency has risen to the forefront of public health debate after dramatic predictions last year about a swine flu pandemic did not come true.

Some countries, notably Poland, declined to join the panic-buying of vaccines and antivirals triggered when the WHO declared the swine flu outbreak a pandemic a year ago this week. The UK, which warned that 65,000 could die as a result of the virus, spent an estimated £1bn stockpiling drugs and vaccines; officials are now attempting to unpick expensive drug contracts.

The cabinet office has launched an inquiry into the cost to the taxpayer of the panic-buying of drugs.

Today, the Council of Europe, produces a damning report into how a lack of openness around "decision making" has bedevilled planning for pandemics.

"The tentacles of drug company influence are in all levels in the decision-making process," said Paul Flynn, the Labour MP who sits on the council's health committee. "It must be right that the WHO is transparent because there has been distortion of priorities of public health services all over Europe, waste of huge sums of public money and provocation of unjustified fear."

Although the experts consulted made no secret of industry ties in other settings, declaring them in research papers and at universities, the WHO itself did not publicly disclose any of these in its seminal 2004 guidance. In its note, the WHO advised: "Countries that are considering the use of antivirals as part of their pandemic response will need to stockpile in advance."

Many nations would adopt this guidance, including Britain. In 2005, the government said it had begun bulk-buying the drug Tamiflu, initially ordering 14.6m doses after bird flu killed 40 in Asia.

The specific guidance on antivirals was written by Professor Fred Hayden. He has confirmed in an email that he was being paid by Roche for lectures and consultancy work at the time the guidance was produced and published. He received payments from GSK for consultancy and lecturing until 2002. He said "[declaration of interest] forms were filled out for the 2002 consultation".

The previous year Hayden was also one of the main authors of a Roche-sponsored study that asserted what was to become a main Tamiflu selling point – its claim of a 60% reduction in flu hospitalisations.

Dr Arnold Monto was the author of the WHO annex dealing with vaccine usage in pandemics. Between 2000 and 2004, and at the time of writing the annex, Monto had openly declared consultancy fees and research support from Roche and GSK. No conflict of interest statement was included in the annex published by the WHO.

When asked if he had signed a declaration of interest form for WHO, Dr Monto said "conflict of interest forms are requested before participation in any WHO meeting".

The third scientist, Professor Karl Nicholson, is credited with the WHO's influential work Pandemic Influenza. According to declarations he made in the BMJ and Lancet in 2003, he had received sponsorship from GSK and Roche.

Even though the previous year these declarations had been openly made, no conflict of interest statement was included in the annex. Nicholson said he last had "financial relations" with Roche in 2001.

When asked if he had signed a declaration of interest form for WHO, he replied: "The WHO does require attendees of meetings, such as those held in 2002 and 2004, to complete declarations of interest."

A WHO official told the BMJ it had to balance an individual's privacy with the robustness of guidelines, which were subject to a wide external review process.

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Child flu jab trial results out

Children respond well to swine flu vaccines, trial shows

Swine flu: One year on

This time last year, swine flu was on the brink of becoming a major global health story. With hindsight we can be thankful that the pandemic was mild for most while serious for a small minority.

In retrospect was it all a huge, global over-reaction? Not according to a team of experts assembled by the Science Media Centre. Professor Robert Dingwall from the University of Nottingham wondered what journalists would have said had the pandemic turned out to have been as serious as that in 1918.

Professor Peter Openshaw from Imperial College London said the public-health response had been proportionate and that politicians had listened to the experts. The general tone of those assembled was that it's always better to prepare for the worst rather than simply hope for the best. Mike Grannatt, formerly of the Cabinet Office and now an expert in risk communication, said the government must not be afraid of crying wolf in the future, because "one day the wolf will come" in the form of a more serious pandemic.

There are lessons to be learned. Professor Neil Ferguson, a leading disease modeller, felt that although his team was able to quickly determine that the H1N1 virus was mild for most, it took much longer to assess what the effect would be on the health service.

Professor Ferguson, an epidemiologist at Imperial College London, said ball-park projections for the transmissibility and severity of the virus were calculated within weeks of the first cases being highlighted in Mexico. This meant when the virus began circulation in the UK, people were aware that it was worth taking note of, but there was no reason to panic. But transforming ball-park projections into more accurate ones was more problematic.

Professor Dingwall pointed out the pandemic is not over. We are at the beginning of the flu season in the southern hemisphere. "We can't relax our vigilance, especially since the historic evidence is that a more virulent second wave is possible," he said.

I should stress that most experts, including Professor Dingwall think it unlikely that the H1N1 virus will mutate into something much more serious. Unlikely, but not impossible. Neil Ferguson said there had recently been a resurgence of flu in some southern American states, notably Alabama.

So the H1N1 virus is still out there. Dr Stephen Gardner, influenza policy director at GlaxoSmithKline, said the H1N1 pandemic strain is now being incorporated into seasonal flu vaccines. Seasonal flu jabs are trivalent; in other words, they are effective against three different strains of influenza. That should greatly simplify the vaccination process, for patients and GPs, when the flu season begins this autumn.

Flu vaccine lifts Novartis profit

The great flu conspiracy | Zoe Williams

The idea of Big Pharma duping the WHO over swine flu is thrilling. The reality is more prosaic

It emerged this week that the Department of Health over-bought swine flu jabs by 30 million doses or, to interject coarsely with mention of money, £150m. That money went somewhere: Big Pharma, the target of nineties-noughties conspiracists. In this case, it was GlaxoSmithKline, though there was originally a side order with Smaller Pharma, Baxter.

While the Tories try to make mileage out of an alleged mishandling, Labour MP Paul Flynn questions the advice from the World Health Organisation that spurred the huge purchase in the first place. He points to all the recent scares that have failed to live up to their deadly billing: Sars, CJD, avian flu. Flynn is involved in a Council of Europe inquiry into the influence of drug companies on government policy, so is likely to be trenchant. Still, I was surprised by his boldness when he said, on the Today programme yesterday: "Did they make these terrifying claims because of epidemiology or did they do it under pressure from pharmaceutical companies?"

It's an enormous charge against the WHO. If it were to stand up, the consequences would be vast. The idea of a central, co-ordinated advisory body on health would probably be ended.

The organisation itself, not surprisingly, rebuts this in the strongest terms. Gregory Hartl, a WHO spokesman, said: "Unequivocally, there is no influence on the WHO by big pharmaceutical companies. We of course have contact with them. It would be irresponsible of us not to work to develop the best tools possible. At the same time, we do have in place internal safeguards to ensure that vaccine manufacturers or individuals associated with them do not exert influence on WHO." Well, sure, you have to imagine this said with feeling – it does seem a little underpowered.

The British Medical Association is in complete accord. Its pandemic flu chief, Peter Holden, is adamant there were no vested interests anywhere near this – and furthermore puts it in context: the world was due a flu pandemic; the NHS had anticipated the crisis, putting out new guidance for GPs in January 2009; that guidance had to take into account not just the flu itself but the change in national circumstances since the last pandemic, in 1968. We only have two-thirds as many hospital beds as we did in 1997. "There are social changes, both parents in a household probably work, we live in a just-in-time economy, there are only four days' food on the shelves, seven days' supply in pharmacies. We had to keep the hospitals liquid; keep the intensive care system running as long as we could; keep as many people at work as we could. What you want to avoid at all costs is civil disorder." Holden is convinced of, and pretty convincing on, the sagacity of the measures taken. One of his simplest points is that the vaccine was ordered on the understanding that people would need two doses; it turned out one would do, but there was no way of knowing that until it had passed into use.

There's a slight faultline here, which is that H1N1 still turned out to be a disease non-event, and the actions taken by individual countries are only as sensible as the threat level issued by the WHO. Hartl points out that, if you measure it in life years, rather than lives, it has had the largest impact of any flu in recent years – most of its victims being young people, children and pregnant women. "I would use the analogy of a seatbelt; if you wear a seatbelt and don't crash, you don't think that's a waste of time." But there's no cost involved in a seatbelt: we're not yet so grand a species that any cost, however large, is preferable to any risk, however small. "I'm not an economist, I can't get into those kinds of questions."

I don't think the WHO is in the grip of pharmaceutical paymasters: It's enough just being the WHO for most of your threats to be overstated. It is in the nature of epidemiology that it's a blunt tool – all you can do is move with the middle of the graph. So even within the borders of one nation, guidelines won't be right for everybody. You'd expect your own government to be stringent. But there is almost no advice that would work equally well across nearly 200 countries at levels of development that vary from Gabon to Germany.

Very few aspects of health don't rely on factors like population density, sanitation, underlying wellness and access to drugs. So either we have to accept that a centralised body will frequently be pessimistic to the point of purposelessness or we have to let go of the idea of a centralised body altogether. If only there were a conspiracy, this would be a lot easier.

• This article was amended on 10 April 2010. The original said that the WHO "refutes" the accusation against it. This usage has been corrected.

Swine fluHealthHealth policyHealthcare industryPharmaceuticals industryGlaxoSmithKlineSarsBird flu

Opinions: Preparing for next flu outbreak; Elections in Zimbabwe; U.S. response to Haiti

NHS left with 34m swine flu jabs

Swine flu vaccine orders cancelled

Government cancels swine flu vaccine order

Department of health has struck a deal with drug giant GlaxoSmithKline to cancel part of its massive order for swine flu vaccine, it emerged today

The government has struck a deal with the British drug giant GlaxoSmithKline to cancel part of its massive order for swine flu vaccine, it emerged today.

The government ordered 90 million doses of swine flu vaccine - enough to vaccinate the entire population and more per head than any other country in Europe. With flu cases down to below 5,000 a week - as they have been for the last three months - it has become very clear that the UK has substantially more vaccine than it needs.

The agreement will save a third of the value of the contract the government entered into with GSK to buy its vaccine Pandemrix, the department of health said. But the NHS will still be left with many more doses than it needs - it will now pay for 38.4 million doses from GSK instead of 60 million (a further 30 million were ordered from Baxter Healthcare but the contract had a get-out clause and was terminated at the end of February). But less than 5 million people have been vaccinated in England.

GSK will not suffer from the cancellation - the deal involves a commitment by the department of health to buy some of its other products instead.

The department of health, which issued a joint statement with GSK, refused to reveal how much money the contract was worth or how much it will still have to pay - but the figures will be substantial. Last September, the government said that it would spend £155.4 million over four years on swine flu vaccine.

The government says the surplus vaccine will be kept as a stockpile in case a "third wave" of swine flu emerges. The 38.4 million doses include those already received by the NHS and those specifically manufactured and stockpiled by GSK for the UK, which, says the statement, could not reasonably be retracted.

As part of the deal, the NHS will also take some stocks of "bird flu" vaccine from GSK and supplies of Relenza, its inhaled antiviral drug, to replace those that have already been used.

"This deal means the UK will save approximately one third of the original value of the orders with GSK," said Health Secretary Andy Burnham. "I am pleased we have reached an agreement that is good value for the taxpayer and means that the department has retained a strategic stockpile to protect the UK population without incurring a cancellation fee. This both protects the public purse and ensures the UK remains at the forefront of pandemic preparedness worldwide.

"The probability of a 'bird flu' pandemic, which is likely to be more severe than swine flu, has not diminished. This agreement means we are ready if a 'bird flu' pandemic occurred, and allows us to maintain our status as one of the most prepared countries in the world."

Labour MP Paul Flynn, who is involved in an investigation by the Council of Europe into the flu pandemic and allegations of drug company influence on World Health Organisation and government policies, said he was glad a limit had been set on vaccine purchase but called for more transparency.

The UK bought "vastly more than any other country we know of", he said, but would not reveal the price it paid per dose. He pointed out that the Polish health minister told the Council of Europe's investigation last week that her country refused to buy any vaccine at all - and yet the outcome had been little different from that in the UK. The drug companies selling flu vaccines and medicines, he said, "have made millions and their profits have shot up".

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Swine flu vaccine uptake figures

Is there anyone out there still interested in swine flu?

Clearly the H1N1 virus has had its day in terms of being a big news story. Barring a sudden resurgence next autumn or some unusual mutation, we can be thankful that the first pandemic of the 21st Century was as mild as could be hoped.

But in the interest of dotting a few i's and crossing some t's, I offer the following:

The Department of Health has released swine flu vaccine uptake figures for England. 37% of those in at-risk groups (asthma, heart disease, pregnant women etc) were immunised while 20% of healthy children under 5 received the swine flu jab. 40% of front line healthcare workers have also been immunised.

The Department of Health has said anyone travelling to the Southern Hemisphere, including the World Cup in South Africa, should be vaccinated to prevent them from catching the virus and bringing it back. The flu season will be in full swing in South Africa during the tournament.

Despite it still being flu season here, there is very little swine flu about. Latest figures for England suggest the number of new cases in the last week is below 5,000 where it has been for the last 12 weeks. There are 65 patients in hospital, 14 of them in critical care.

The death toll from the H1N1 virus now stands at 457 in the UK since the outbreak began almost a year ago. Probably several million Britons have had swine flu and most will have had either no symptoms or a mild illness.

Useful resources:

• Detailed UK weekly epidemiology update
• Swine flu figures for Northern Ireland
• Swine flu figures for Scotland
• Swine flu figures for Wales

World Cup swine flu vaccine urged

Poland swine flu threat remains

Voluntary System Works For Swine Flu Vaccination

From headline news to has-been

Swine flu began as a global health emergency, but thankfully never lived up to the initial fears. Cast your mind back to July 2009 and Britain was in the grip of swine flu fever. There were more than 100,000 cases a week and it dominated the headlines. When the National Pandemic Flu Service was launched it initially went into meltdown. Little wonder as at one point the website was getting 2,600 hits per second.

The chief medical officer for England, Sir Liam Donaldson described the media interest as unprecedented, reaching "Michael Jackson proportions" (the pop legend died the previous month).

Today there is so little demand for the online and telephone service (where you can get Tamiflu simply by answering a series of tick-box questions) that it will be shut down at 1am on Thursday 11 February. The service only ever operated in England.

So does this mean we can forget about swine flu? And was it all a huge over-reaction? Millions of Tamiflu tablets remain in warehouses unused, and unless we get a fresh pandemic in the next couple of years, they are likely to pass their sell-by date. You could argue that was a waste of money, but it is easy to be wise after the event.

Professor Wendy Barclay, a virologist from Imperial College London says that the pandemic could have been a lot worse:

By my reckoning (and this is an estimate only) around 5.25 million people have been vaccinated in Britain. That means there is an awful lot of vaccine - tens of millions of doses - going spare. I'm told an announcement is likely in around 10 days regarding what will be done with the remaining stocks. As yet we don't have figures for how much the vaccine cost - due to commercial confidentiality.

A huge over-reaction or prudent planning? Sir Liam Donaldson says that he would rather be accused of doing too much to protect the population than too little:

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So has swine flu gone for good? Absolutely not. There may be very few cases now, but it's likely to be back next autumn and for years to come, replacing other flu strains to become the dominant seasonal flu virus.

That's why the government is recommending vaccination for everyone at risk of flu complications, plus all healthy children aged six months to under-five. Swine flu has been a very mild illness for the vast majority, but 60 children in England have died since last April. Given that this is now a vaccine-preventable illness, immunisation now should prevent the chance of them getting the virus in the future.

500,000 swine flu jabs stockpiled

Protect kids against swine flu, doctors urge