The international response to the influenza pandemic: WHO responds to the critics

Pandemic (H1N1) 2009 briefing note 21

Background

10 JUNE 2010 | GENEVA -- On Friday 4 June 2010, the BMJ, formerly British Medical Journal, and the Parliamentary Assembly of the Council of Europe (PACE) simultaneously released reports critical of the World Health Organization's handling of the H1N1 pandemic. WHO takes the issues and concerns that were raised seriously and wishes to set the record straight on several points.

Is this a genuine pandemic?

The outbreaks of infection with the new H1N1 virus, which have been confirmed in virtually every country and territory in the world, differ from seasonal influenza in distinct ways. These differences meet the criteria for an influenza pandemic.
 
1. The first human infections with the new H1N1 virus were confirmed in April 2009. Analysis of laboratory samples showed that the new virus had never before circulated in humans. This is a virus of animal origin with a unique mix of genes from swine, bird, and human influenza viruses. The genetic composition of this virus is distinctly different from that of the older H1N1 virus that has been causing seasonal epidemics since 1977.
 
2. As the virus spread, it demonstrated epidemiological patterns not seen during seasonal epidemics of 
influenza. Widespread, high levels of infection with the new virus occurred during the summer in the northern hemisphere in multiple countries, followed by even higher levels during the fall and winter months. In countries with a temperate climate, seasonal epidemics typically taper off in the spring and end before summer.
 
3. The pattern of illness and death caused by the H1N1 virus differed in striking ways from that seen 
during seasonal influenza. During seasonal epidemics, more than 90% of deaths occur in the frail elderly. The H1N1 virus affected a younger age group in all categories: those most frequently infected, those requiring hospitalization, those requiring intensive care, and those dying from their infection.
A frequent cause of death was viral pneumonia, caused directly by the virus and difficult to treat. During seasonal epidemics, most cases of pneumonia are caused by secondary bacterial infections, which usually respond well to antibiotics. While many of those who died had underlying medical conditions associated with a higher risk, many others who died were previously in good health.
 
4. The new H1N1 virus rapidly crowded out other circulating influenza viruses and appears to have displaced the older H1N1 virus. This phenomenon is distinctly seen during pandemics.
 
5. Early studies showed that antibodies to H1N1 seasonal influenza did not protect people from infection with the new virus. This finding provided critical evidence that the virus was new to the human immune system. Later studies in some countries determined that around one third of people older than 65 years had some immunity to the virus. Younger people, however, had no such protective immunity.

Did WHO remove severity from the definition of a pandemic?

WHO regards severity as an important feature of pandemics and a critical factor when deciding on which actions to take. However, WHO has not required a set level of severity as part of its criteria for declaring a pandemic. Experience shows that all pandemics cause excess deaths, that severity can change over time, and that severity can vary according to location and population.
 
WHO has published three definitions of an influenza pandemic in the context of phases of pandemic alert. These definitions were contained in broader guidelines for pandemic preparedness issued in 1999, 2005 and 2009. Research on influenza pandemics and pandemic viruses increased considerably following the first human cases of infection with the H5N1 avian influenza virus in 1997. Definitions changed over time in line with this evolving knowledge and the need to increase the precision and practical applicability of phase definitions.
 
The 2009 guidelines, including definitions of a pandemic and the phases leading to its declaration, were finalized in February 2009. The new H1N1 virus was neither on the horizon at that time nor mentioned 
in the document.
 
The media make frequent reference to a 2003 document, available on the WHO web site, stating that an influenza pandemic results in “enormous numbers of deaths and illness”. At the time, this was considered a likely scenario should the highly lethal H5N1 avian influenza virus develop an ability to spread readily among humans, but it was never a formal definition.

Influenza pandemic plan: the role of WHO and Guidelines for national and regional planning. [pdf 227kb]
WHO, 1999

WHO global influenza preparedness plan: the role of WHO and recommendations for national measure before and during pandemics. [pdf 372kb]
WHO, 2005

Pandemic influenza preparedness and response: a WHO guidance document. [pdf 339kb]
WHO, 2009

Did WHO exaggerate the threat?

When WHO Director-General Dr Margaret Chan announced the start of the pandemic, on 11 June 2009, she expressed the view that the pandemic would be of moderate severity. She further noted the relatively small number of deaths worldwide, and clearly stated that “we do not expect to see a sudden and dramatic jump in the number of severe or fatal infections.”

In every assessment of the pandemic, WHO consistently reminded the public that the overwhelming majority of patients experienced mild symptoms and made a rapid and full recovery, even without medical treatment.

WHO also noted, early on, that influenza viruses are unstable and can undergo rapid and significant mutations, making it difficult to predict whether the moderate impact would be sustained. This uncertainty, which persuaded WHO and many national health authorities to err on the side of caution, was further enforced by the behaviour of past pandemics, which varied in their severity during first and second waves of international spread.

Were any WHO pandemic decisions made to increase industry profits?

No. Allegations that WHO declared a pandemic to boost the profits of the pharmaceutical industry arise from WHO’s use of expert advisers and the way declarations of interest from these experts are handled. No evidence of any specific instance of wrongdoing has emerged from recent enquiries.

What safeguards are in place to guard against conflicts of interest?

Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and profit-driven industry. Advice from top experts is sought by industry as well as by agencies like WHO that need to issue guidance based on the best expertise. Many experts who advise WHO have ties with industry, and these ties can range from funding to conduct research, to paid consultancies, to participation in conferences sponsored by industry.
 
WHO has systems in place to protect the Organization from advice biased by commercial interests. WHO requires all expert advisers to declare their professional and financial interests when they participate in advisory groups and consultations. WHO assesses declared interests to determine whether a potential conflict or a potential perception of conflict exists. Where necessary, WHO requests more detailed information and then decides on the appropriate action to be taken.
 
The publication of summaries of relevant interests following meetings is inconsistent and needs to be made routine. WHO further acknowledges that safeguards surrounding engagement with industry need to be tightened, and is doing so.

What is the function of the Emergency Committee and why have the names of its members not been disclosed?

The International Health Regulations (IHR) contain a set of requirements that are legally binding for WHO and the 194 States Parties of the IHR. The IHR call upon the WHO Director-General to convene an Emergency Committee, drawn from a standing roster of IHR experts, to provide WHO with independent guidance during public health emergencies of international concern, such as an influenza pandemic. The IHR came into force in 2007.
 
The emergence of the new H1N1 virus prompted the first convening of an Emergency Committee under the IHR. At that time, WHO debated whether or not to publicly disclose the names of members, and faced a dilemma. On one hand, the names of members of other advisory groups are made public after they meet; the identification of persons offering guidance adds transparency to their advice and subsequent WHO decisions. On the other hand, experiences during the SARS outbreak demonstrated the considerable economic and social disruption caused by some public health emergencies, meaning that experts could well be lobbied or pressured for commercial or political reasons, potentially compromising the objectivity of their advice.
 
After considering these issues, WHO decided to apply its usual practice of disclosing the names of experts after an advisory body has completed its work. The members themselves welcomed this decision as a protective measure, and not as an attempt to veil their deliberations and decisions in secrecy. However, given the duration of the pandemic, the Emergency Committee has held a number of meetings over more than a year, rather than a single meeting like most advisory groups, thus delaying even further the release of the names of its members.
 
WHO is now fully aware that this decision has fostered suspicion that the Committee might be providing guidance shaped by commercial interests or pressures. Names of members and a summary of relevant declarations of interest will be made public when the Committee advises that the pandemic has ended. Procedures for revealing names of members of future Emergency Committees are under review.

What evidence supports a role for antiviral drugs during an influenza pandemic?

Given widespread population vulnerability to infection, an influenza pandemic presents health authorities with a significant challenge in finding ways to protect populations. From the outset, WHO has recommended a wide range of measures, including hand washing, respiratory hygiene, and not travelling or going to work when ill, and has offered advice on the clinical care of patients and the use of antiviral drugs and vaccines.
 
At the start of the pandemic, data from the Centers for Disease Control and Prevention (USA) showed that the new virus was sensitive to oseltamivir and zanamivir. Prior to the pandemic, WHO had developed guidelines for the treatment of severe influenza infections caused by the avian H5N1 influenza virus. These two factors allowed WHO to rapidly issue guidelines for use of antivirals in the context of H1N1 pandemic influenza, with emphasis on the treatment and prevention of severe illness.
 
Over the course of the pandemic, an increasing volume of clinical data has been published in peer-reviewed medical journals. These studies confirm that prompt use of antivirals correlates with improved recovery from illness and fewer deaths. Evidence shows that antivirals have been especially effective for treating patients at increased risk of developing complications from H1N1^[1].

WHO Guidelines for Pharmacological Management of Pandemic (H1N1) 2009 Influenza and other Influenza Viruses
February 2010

Was a WHO meeting held in 2002 on influenza vaccines and antiviral drugs influenced by industry?

In 2002, WHO convened a consultation with experts to develop a document, WHO guidelines on the use of vaccines and antivirals during influenza pandemics, which was published in 2004. Some critics have alleged that certain experts who participated in the meeting and the drafting of the guidelines had ties with industry interpreted as conflicts of interest. In line with WHO policy, all experts who participated in this meeting were required to submit a declaration of interest form and all such forms were duly reviewed by WHO. However, a summary of relevant interests was not issued together with the publication. WHO regrets this oversight.
 
Since that time, a number of administrative and legal changes have been implemented to strengthen procedures for addressing potential conflicts of interest that might influence the advice provided to WHO. WHO is committed to tightening these procedures further and ensuring their more consistent application. 


^[1] See for example: Siston et al. Pandemic 2009 Influenza A(H1N1) virus illness among pregnant women in the United States. Journal of the American Medical Association, 2010, 303: 1517-1525

Council of Europe: PACE Health Committee denounces ‘unjustified scare’ of Swine Flu

Press release - 455(2010) PACE Health Committee denounces ‘unjustified scare’ of Swine Flu, waste of public money Strasbourg, 04.06.2010 – The handling of the H1N1 pandemic by the World Health Organization (WHO), EU agencies and national governments led to a “waste of large sums of public money, and unjustified scares and fears about the health risks faced by the European public”, according to a report by the Social, Health and Family Affairs Committee of the Parliamentary Assembly of the Council of Europe (PACE) made public today in Paris. The report, prepared by Paul Flynn (United Kingdom, SOC) and approved today by the committee ahead of a plenary debate at the end of this month, says there was “overwhelming evidence that the seriousness of the pandemic was vastly overrated by WHO”, resulting in a distortion of public health priorities. Presenting his report, Mr Flynn told the committee: “this was a pandemic that never really was”, and described the vaccination programme as “placebo medicine on a large scale” (see video below). In its adopted text, the committee identifies what it calls “grave shortcomings” in the transparency of decision-making about the outbreak, generating concerns about the influence of the pharmaceutical industry on decisions taken. Plummeting confidence in such advice could prove “disastrous” in the case of a severe future pandemic, it warns. In particular, the WHO and European health institutions were not willing to publish the names and declarations of interest of the members of the WHO Emergency Committee and relevant European advisory bodies directly involved in recommendations concerning the pandemic, the parliamentarians point out. However, attending the meeting was Fiona Godlee, the Editor-in-Chief of the British Medical Journal, who told the parliamentarians that, according to an investigation by her journal, scientists who drew up key WHO guidelines on stockpiling flu vaccines had previously been paid by drug companies which stood to profit. The WHO has been “highly defensive”, the committee said, and unwilling to accept that a change in the definition of a pandemic was made, or to revise its prognosis of the Swine Flu outbreak. The committee sets out a series of urgent recommendations for greater transparency and better governance in public health, as well as safeguards against what it calls “undue influence by vested interests”. It also calls for a public fund to support independent research, trials and expert advice, possibly financed by an obligatory contribution of the pharmaceutical industry, as well as closer collaboration with the media to avoid “sensationalism and scaremongering in the public health domain”. The report is due to be debated by parliamentarians from all 47 Council of Europe member states on Thursday 24 June during PACE’s summer session in Strasbourg. Contacts In Paris: Francesc Ferrer, mobile: +33 (0)6 30 49 68 22 In Strasbourg: PACE Communication Division, tel. +33 (0)3 88 41 31 93, mobile: +33 (0)6 30 49 68 20 Mr Flynn’s report (provisional version) (PDF) Video of the committee’s exchange of views today (English) Video of the committee’s exchange of views today (original languages) Parliamentary Assembly Communication Unit Tel: +33 3 88 41 31 93 Fax : +33 3 90 21 41 34 pace.com@coe.int assembly.coe.int

AFP: WHO sets up swine flu probe

WHO sets up swine flu probe

Apr 12, 10 3:23pm

 

Health experts on Monday begin examining the controversial response to the first influenza pandemic of the 21st century, nearly a year after global alarm was raised over the new swine flu strain.

The World Health Organisation is forming a panel of 29 external experts following accusations that the agency-led international reaction to A(H1N1) influenza was overblown and may have been tainted by commercial interests.

After the formative three-day meeting, the International Health Regulations review committee's work is expected to take about nine months, WHO spokesman Gregory Hartl said.

WHO Special Adviser on Pandemic Influenza Keiji Fukuda recently admitted that "we still have a lot of things to learn," including the way the risks posed by swine flu are communicated to the public.

However, specialists broadly defended the alarm over the discovery of A(H1N1) cases in Mexico and 

the United States in April 2009 as well as the WHO's declaration of a pandemic in June as the flu swiftly spread around the world.

"I think they gave a terrific lead and were very authoritative. I think we have a lot to thank them for," John Oxford, a virologist and professor at the Queen Mary's School of Medicine and Dentistry in Britain, told AFP.

"A lot of the criticism is political. I've not heard criticism from any virologist," he added, also 

highlighting the need to cater for impoverished countries with poor surveillance, care and health conditions.

Parliamentarians conducting a Council of Europe probe have criticised the transparency of decision-making and especially the potential influence of the pharmaceutical industry on a decision last year to press for vaccination.

That inquiry was set up after several governments sought to cancel mass orders of hundreds of millions of dollars worth of swiftly developed special pandemic vaccines, when fears about the severity of swine flu died down.

British MP Paul Flynn, who is leading that probe, declined to comment before he meets WHO officials in Geneva on Thursday.

David Heymann, a former head of infectious diseases at the WHO who left the agency in early 2009, voiced concern about public reticence towards vaccination in generally healthy Western populations.

- AFP

WHO: Swine flu prevalent throughout the world, cold and hot...

WHO: Climate does not have an effect on Swine flu virus

NST 2009/08/24

The World Health Organisation (WHO) has said the swine flu virus is not affected by any variation in the temperature, the Press Trust of India (PTI) reported.

Citing cumulative report of swine flu cases and deaths from different nations around the globe, WHO said the H1N1 virus has infected people from several countries with varying temperatures.

As per a WHO report, nearly 1,800 deaths registered from across 177 countries and territories around the globe.

Dr S J Habayeb, WHO representative in India, said, "H1N1 virus has no relation to weather. Swine flu cases have been heard from countries with cold and hot temperatures."

Citing example, he said, "Swine flu cases have been equally reported from Texas, New York and California, though the temperature varies in all the three places. Texas is warmer than New York."

According to WHO, North and South America reported highest number of A/H1N1 cases, where more than 1,500 deaths have been reported.

This has been followed by European countries with over 32,000 people testing positive for the virus and more than 50 deaths reported from all over the continent.

The third most affected area is the western pacific region with over 27,000 cases already testing positive for H1N1 and 50 deaths reported from there.

It is followed by the South-East Asian region. Nearly 13,000 positive cases and 106 deaths have already been reported from different countries in this region.

Finally, the Mediterranean region has over 2,000 cases and eight deaths have been reported from there so far.

Dr Jai P Narain, Director, Communicable Diseases, WHO, said, "If cases are being reported in hot and humid climate like India, the same is also being heard about in cold country like Australia."

"All depends on the immune capacity of the people. All five continents have been affected equally," he said. - Bernama

Beijing H1N1 Conference: WHO predicts 'explosion' of swine flu cases

WHO predicts 'explosion' of swine flu cases

By GILLIAN WONG (AP) – 2 days ago

BEIJING — The global spread of swine flu will endanger more lives as it speeds up in coming months and governments must boost preparations for a swift response, the World Health Organization said Friday.

There will soon be a period of further global spread of the virus, and most countries may see swine flu cases double every three to four days for several months until peak transmission is reached, said WHO's Western Pacific director, Shin Young-soo.

"At a certain point, there will seem to be an explosion in case numbers," Shin told a symposium of health officials and experts in Beijing. "It is certain there will be more cases and more deaths."

WHO has declared the swine flu strain a pandemic, and it has killed almost 1,800 people worldwide through last week. International attention has focused on how the pandemic is progressing in southern hemisphere countries such as Australia, which are experiencing winter and their flu season.

But it is in developing countries where the accelerated spread of swine flu poses the greatest threat as it places underequipped and underfunded health systems under severe strain, Shin said.

Governments must act quickly to educate the public, prepare their health systems to care for severe cases and protect those deemed more vulnerable to prevent unnecessary deaths, he said.

"We only have a short time period to reach the state of preparedness deemed necessary," Shin said. "Communities must be aware before a pandemic strikes as to what they can do to reduce the spread of the virus, and how to obtain early treatment of severe cases."

Pregnant women face a higher risk of complications, and the virus also has more severe effects on people with underlying medical conditions such as asthma, cardiovascular disease, diabetes, autoimmune disorders and diabetes, WHO chief Margaret Chan said in a video address.

WHO earlier estimated that as many as 2 billion people could become infected over the next two years — nearly one-third of the world's population.

Health officials and drug makers, meanwhile, are looking into ways to speed up production of a vaccine before the northern hemisphere enters its flu season in coming months. Estimates for when a vaccine will be available range from September to December.

WHO has stressed that most cases are mild and require no treatment, but the fear is that a rash of new infections could overwhelm hospitals and health authorities, especially in poorer countries.

The last pandemic — the Hong Kong flu of 1968 — killed about 1 million people. Ordinary flu kills about 250,000 to 500,000 people each year.

Swine flu is also continuing to spread during summer in the northern hemisphere. Normally, flu viruses disappear with warm weather, but swine flu is proving to be resilient.

Healthy people with swine flu do not need Tamiflu, says WHO

Healthy people with swine flu do not need Tamiflu, says WHO

LONDON, Aug 22 — Healthy people who catch swine flu need not be given Tamiflu, the World Health Organisation (WHO) has announced. The advice appears to contradict the UK’s policy of making the antiviral drug readily available to those who call the national pandemic helpline or approach their GPs.

Hundreds of thousands of doses have been given to British patients although the majority have not been severely ill. Fears have been voiced that mass use of Tamiflu will make the virus resistant to it.

The latest advice from the WHO said: “Worldwide, most patients infected with the pandemic virus continue to experience typical influenza symptoms and fully recover within a week, even without any form of medical treatment. Healthy patients with uncomplicated illness need not be treated with antivirals.”

Previously the WHO had said antivirals should be given to patients with “serious progressive illness”. The new guidance is the first time it has specifically advised against otherwise healthy individuals being given the drug.

The recommendation is based on the conclusion of an international panel of experts that includes representatives from the UK. The advice added that Tamiflu, also called oseltamivir, and the similar drug Relenza, also called zanamivir, should be given quickly to seriously ill or deteriorating patients.

The WHO guidance said at-risk groups should receive the drugs. “For patients with underlying medical conditions that increase the risk of more severe disease, WHO recommends treatment with either oseltamivir or zanamivir.

“These patients should also receive treatment as soon as possible after symptom onset, without waiting for the results of laboratory tests. As pregnant women are included among groups at increased risk, WHO recommends that they receive antiviral treatment as soon as possible after symptom onset.”

Some medical researchers have expressed concern about the side-effects of Tamiflu, particularly sickness, nightmares and insomnia in children. A team from Oxford University said this month that children with mild symptoms should not be given Tamiflu and urged the Department of Health (DoH) to urgently rethink its policy.

Figures released by the DoH show that 45,986 courses of antivirals were given to patients in England in the week ending 18 August. In the previous week 90,363 courses of antivirals were given out. The data relates to people collecting the drugs after an assessment via the National Pandemic Flu Service. Many more have collected antivirals via their GP.

The DoH said the new WHO guidance was not too different from its own position that people with mild symptoms could recover without antiviral drugs.

The new WHO statement said: “Worldwide, around 40 per cent of severe cases are now occurring in previously healthy children and adults, usually under the age of 50 years. Some of these patients experience a sudden and very rapid deterioration in their clinical condition, usually on day five or six following the onset of symptoms.”

The first deaths of patients in Wales and Northern Ireland with swine flu has been announced, bringing the number of UK deaths to 61. In Wales, a 55-year-old woman was admitted to the Royal Gwent hospital in Newport on 2 August and given antiviral drugs. She developed cardiac problems and died on Saturday.

In Northern Ireland, a female patient who was said to have had an underlying health condition died last night in hospital. No further details were released.

The Department of Health has hinted that accumulating evidence about the degree of severity of the outbreak might lead to a change in policy. A spokesman said: “We believe a safety-first approach of offering antivirals, when required, to everyone remains a sensible and responsible way forward. However we will keep this policy under review as we learn more about the virus and its effects.”

“The WHO recommendations are in fact in line with UK policy on antivirals. We have consistently said that many people with swine flu only get mild symptoms and they may find bed rest and over-the-counter flu remedies work for them.

“WHO state that 40 per cent of severe cases worldwide have been in previously healthy children and adults and that serious cases should be treated immediately. This emphasises the need not to become complacent about the mildness of the illness and the reasoning behind a precautionary policy.

“People with underlying health conditions, pregnant women and parents with children under the age of one should speak to their GP if they have symptoms. If people have any doubts about taking antivirals they should contact their GP.” — Guardian

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My Comments:

A(H1N1) flu as a novel disease has no precedent on what is the absolutely correct approach.... Just another potentially confusing conflicting situation, which shows up the shifting uncertainties of handling this pandemic H1N1 flu, even by the WHO...

Malaysians should not be too ready to confer blame on authorities and doctors when most of these approaches/directives are also changing/modifying from the world's highest authorities...

However, many Malaysians are now so suspicious and cynical as to anything smacking of governmental conspiracy and obfuscation, that we seem to have lost the art of rational discourse (sigh!), someone or everyone who collaborates, must be blamed! Including the harbinger of news or information, no matter how apolitical, so sad...

H1N1 update: WHO restates H1N1 drugs recommendations

WHO restates H1N1 drugs recommendations

GENEVA, Aug 12 — Adults and children who are severely ill with H1N1 flu or at high risk of complications should be treated with antivirals like Tamiflu, the World Health Organisation (WHO) said today.

But otherwise healthy people with mild flu-like symptoms need not be given the drugs to combat swine flu, it said.

The United Nations agency reiterated advice first issued on May 21 on the use of antivirals for patients infected with the H1N1 virus, which applies to patients above one year old.

“WHO continues to recommend use of antivirals as treatment for people who are severely ill or are at risk of other health complications,” it said in a statement sent to journalists.

Prompt antiviral treatment with oseltamivir, the generic name for Tamiflu made by Swiss drug maker Roche Holding, is recommended for “at risk” groups including pregnant women.

“Antivirals need not be administered for otherwise healthy individuals with mild flu like symptoms,” it said.

British researchers said this week that children should not routinely be treated with flu drugs like Tamiflu since there is no clear evidence they prevent complications and the medicines may do more harm than good.

They called for a rethink of current widespread use of antivirals among under-12s in the light of an analysis of clinical data from past outbreaks of seasonal flu showing scant benefits and potentially harmful side effects.

In its statement, the WHO said its expert panel had recently reviewed its guidance on the use of antivirals as treatment for patients with H1N1 pandemic flu.

The experts had considered clinical evidence, including that used in the British Medical Journal for review, which the WHO noted had concerned seasonal and not pandemic H1N1 flu.

“The recommendation doesn’t change,” WHO spokeswoman Alphaluck Bhatiasevi told Reuters.

Roche said there were significant clinical data showing Tamiflu to be effective and well tolerated in children, and the data had been taken into account by both US and European drug regulators in approving the medicine for youngsters. — Reuters