07 June 2010
The EU Commission launches its consultation on "Strengthening European Union Preparedness on Pandemic Influenza" against a background of accusations that the threat of this pandemic was overstated and that European countries (with the exception of Poland) were persuaded to invest too much in stocks of anti-viral medicines. This controversy was fuelled by the revelations published in the BMJ 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), which produces Relenza. The report by Paul Flynn, a UK Member of Parliament, on ''The handling of the H1N1 pandemic: more transparency needed'' which was adopted by the Social, Health and Family Affairs Committee of the Council of Europe Assembly at its meeting in Paris on 4 June raises even more questions.
With hindsight it is easy to claim that the threat of an Influenza Pandemic was overstated, now that it appears, that the threat to health was less than expected and perhaps anti-viral medicines were less relevant than thought. But this is the wrong perspective from which to learn lessons from the past, instead we should be asking whether, with the knowledge available at the time the right people and agencies worked well together to come to the best available decisions on the information available with foresight. This provides a very different perspective; it helps us look back with what Collingwood called "historical imagination".
We might start by asking "what was all the fuss about?" why should such a high priority be given to an illness that may keep us in bed for a few days? But far from being a benign seasonal event like the common cold, even seasonal influenza is a major health threat, affecting about 5-15% of the population every year, it causes between 3 and 5 million cases of severe illness and results in from 250,000 to 500,000 deaths each year (almost half the level attributed to malaria). The influenza virus undergoes frequent minor genetic changes, which necessitates global surveillance and annual reformulation of vaccines to protect vulnerable groups from the impacts of seasonal flu epidemics. More importantly influenza viruses have periodically undergone major genetic changes resulting in global pandemics and large tolls in terms of illness and death: "Spanish Flu" is thought to have killed at least 40 million people in 1918-1919. More recently, two other influenza pandemics occurred in 1957 - "Asian influenza" and 1968 - "Hong Kong influenza" which caused significant morbidity and mortality globally, not only amongst old and vulnerable people but, as in the case of Spanish Flu amongst the general population. More recently, outbreaks of a new influenza subtype A(H5N1) called "Bird Flu" directly transmitted from birds to humans occurred in Hong Kong in 1997 and 2003.
At that time the threat of "Bird Flu" was considered severe because it appeared that cases transmitted from birds to humans could be fatal and that further genetic change may have resulted in human to human transmission. The spread of the disease in wild fowl meant that the disease had the potential for unstoppable global transmission. It was against this background that many countries established or re-examined their plans for responding to pandemic influenza and set up contracts for anti-viral medication. While it turned out that transmission from birds to humans was rare and that human transmission was not found, it is surprising that there was not even greater alarm at the time.
In 2003 the EU which was already party to the WHO Global Influenza Surveillance Network and had established the European Influenza Surveillance System, reconfirmed influenza as a priority for disease monitoring and control. In 2004 it established the European Centre for Disease Control (ECDC) as a new EU agency tasked with reinforcing Europe's defences against infectious diseases by fostering cooperation between national public health authorities. ECDC became operational in May 2005 and immediately identified pandemic preparedness for influenza (and other pandemics) as a key priority. Despite have a very limited number of staff it organized visits to all 30 EU EFTA/EEA countries and produced a report on their preparedness by autumn 2006.
The link between national plans and local delivery was a potential weakness identified in the ECDC review. It also suggested that while every country had a national plan a further weakness lay in the link between national health response plans and other aspects of national policy and service delivery. As it transpired the pandemic did not have a major effect on other public services such as transport, we may nevertheless take lessons for future pandemics that may have a wider impact.
All of this provides a background to the most recent "Swine Flu" pandemic and shows the reason for caution. Incidentally the declaration of a global pandemic does not indicate the level of threat posed to individuals but its human to human transmission within communities across countries in different WHO regions. It is the final phase of six in the development of a pandemic, where such phases may be used by governments to trigger actions in their preparation plans such as the purchase and latter distribution of anti-viral medication. The declaration was understood and supported by ECDC experts and government agencies throughout the world, as an important signal for action, however, the gravity given to the declaration by Margaret Chan and the association with fears about "Bird Flu" might well have led the press to overstate the dangers.
A more important question raised by the BMJ and the Council of Europe report is whether the decision processes around pandemic preparedness were sufficiently open and transparent. The accusation that key advisers had previously been paid by pharmaceutical companies for advice on other issues, raises concerns but it appears that the scientists concerned were open about these contacts in their declarations of interest. Short of seeking advice from specialists who have little previous knowledge of the field it is difficult to see how such potential difficulties could be avoided. The Council of Europe report does, however, suggest an antidote to accusations of collusion; greater transparency, engaging academics and civil society in a more open public discussion of issues would ensure greater buy in to the decisions. Politicians could promote action and drug companies would be free to represent the benefits offered by their anti viral products within ethical guidelines and others would be free to question them and perhaps later hold them to account.
It is also fair to point out the disadvantages of greater openness, which include the time and costs required for such ongoing public engagement. Transparency may also increase public alarm before a full analysis of the potential risk is available. More importantly the danger of a slow moving process of consultation lies in the difficulty of responding to the rapidly changing nature of health threats, whether becoming more severe or less threatening as in this case. In the event the nature of the threat posed by "Swine flu" was significantly different from the potential threat foreseen from "Bird flu," which dominated thinking at the time most national plans were prepared. "Swine flu" required a community based response to deliver advice, medication, vaccination and care to a large number of people with relatively mild cases and emergency response to relatively few. Perhaps with hindsight the nature of the response could have been moderated to reflect this emerging pattern, but at the time of planning an over reliance on community organisations might have been less appropriate for the nature of the threat of infection expected. There may now be a danger that local health workers and the public will be sceptical of future health emergencies and less willing to engage.
The one European country that refused to stockpile anti-virals, Poland was able to take a more balanced view of the threat posed by the pandemic. Poland focussed on high risk groups and community level response and while ensuring that anti- virals could be purchased held the pharmaceutical suppliers responsible for any side effects.
The lesson from this is that while openness and transparency is required in preparing for pandemics there is also a need for flexible rapid response. Preparedness plans must be interpreted flexibly as evidence emerges and that the leadership of European, national and local response teams should be more visible and also more adaptable.
At European level one may ask whether the main regional organisations - WHO Euro and ECDC worked well together. It appears that they agreed on a common approach to pandemic preparedness, that WHO Euro promoted this approach and by agreement ECDC developed a more specific assessment tool. This was applied with national agencies so that while in 2005 only 12 European Countries had pandemic preparedness plans, soon all 53 countries of the WHO Euro region will have plans and assessments.
ECDC and WHO Euro and many other agencies carry information and updates on the pandemic including information for health professionals and the public. While this represents some duplication it does not seem to have resulted in confused or mixed messages. Perhaps the lesson to be learnt is how agencies succeeded in providing common message that was neither complacent nor alarmist.
So across Europe, however, defined it appears that pandemic preparation has improved. But one might ask whether there has been a sufficient response to the global impact of such pandemics from the EU. It would appear that, while some increased aid and support has flown into Mexico from US, China and other donors, the position of the EU on support for partner countries that may be impacted by the influenza pandemic is less clear. It does not seem that a common approach has been agreed on the sharing of expertise or indeed sharing of resources such as anti- virals and vaccines. The reaction of Indonesia, which threatened to withhold flu virus samples unless agreement could be reached through discussions at WHO on sharing vaccines, shows the importance of clarity on such issues. In practice this has now been resolved and EU countries find they have a surplus of both anti virals and vaccines (because it was found that 1 inoculation rather than 2 was sufficient and because demand has been low). However, this is an outstanding issue on which clear principles are required.
The fact that the Swine flu is now seen as less of a threat than first appeared likely, may have done some damage to the credibility of health officials in the eyes of the public and perhaps local health professionals. A media autopsy of the event is unavoidable and likely to exacerbate this harm. The controversy over the MMR immunisation programme in the UK, when one researcher (who later turned out to have a financial interest in the issue) spread fears of a link between the immunisation and autism, showed that health officials and professionals do not enjoy unquestioned credibility with the public. Indeed many seem more ready to believe conspiracy theories or the newspapers than health experts. This trust is a vital resource for pandemic preparedness it is therefore essential that health agencies across the EU should plan and coordinate their public relations strategy in the aftermath of the pandemic.
A video of the Council of Europe's Social, Health and Family Affairs Committee discussion can be found at mms://coenews.coe.int/vod/100329_w01_w.wmv
The report by Paul Flynn can be found at here (PDF)