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corruption in H1N1 pandemic declaration

I've previously reported on the bad science around flu vaccine recommendations, and how the flu in general and H1N1 specifically have apparently been overblown as health threats.

(Please note that my considerations here are limited to the flu. This is not an "anti-vaccine" rant; I got a Tdap shot a few months ago -- and felt like crap for a day or two, but given the seriousness of diphtheria, pertussis, and tetanus and the effectiveness of those vaccines, it was worth it.)

Now, the BMJ reports on the conflicts of interest and lack of transparency around the World Health Organization's declaration of the H1N1 pandemic and its recommendations for responses.

Most shockingly, the WHO actually changed the definition of a pandemic in May 2009 so that H1N1 would qualify, removing the qualification that an outbreak must cause "enormous numbers of deaths and illness". And it estimated that 2 billion H1N1 cases were likely -- 1 out of 3 human beings on the whole planet -- even after the winter season in Australia and New Zealand showed that only about one to two out of 1000 people were infected.

It did this while taking advice from people with financial and research ties with Big Pharma companies that produced antivirals and vaccines; one researcher who wrote key guidelines had been paid by Roche and GlaxoSmithKline.

In October 2002 WHO convened a meeting of influenza experts at its Geneva headquarters. Their purpose was to develop WHO’s guidelines for the use of vaccines and antivirals during an influenza pandemic.

Included at this meeting were representatives from Roche and Aventis Pasteur and three experts who had lent their name to oseltamivir’s marketing material (Professors Karl Nicholson, Ab Osterhaus, and Fred Hayden).

Two years later the WHO published a key report from that meeting, WHO Guidelines on the Use of Vaccines and Antivirals during Influenza Pandemics 2004. The specific guidance on antivirals, Considerations for the Use of Antivirals During an Influenza Pandemic, was written by Fred Hayden. Professor Hayden has confirmed to the BMJ/The Bureau in an email that he was being paid by Roche for lectures and consultancy work for the company at the time the guidance was produced and published. He also told us in an email that he had received payments from GlaxoSmithKline for consultancy and lecturing until 2002. According to Prof Hayden: "DOI [declaration of interest] forms were filled out for the 2002 consultation."

The WHO guidance concluded that: "Based on their pandemic response goals and resources, countries should consider developing plans for ensuring the availability of antivirals. Countries that are considering the use of antivirals as part of their pandemic response will need to stockpile in advance, given that current supplies are very limited." Many countries around the world would adopt this guidance.

The previous year Professor Hayden was also one of the main authors of a Roche sponsored study that claimed what was to become one of oseltamivir’s main selling points—a claimed 60% reduction in hospitalisations from flu, which the Cochrane Collaboration was later unable to verify.


Leaving aside the question of what declarations experts made to WHO, one simple fact remains: WHO itself did not publicly disclose any of these conflicts of interest when it published the 2004 guidance. It is not known whether information about these conflicts of interest was relayed privately to governments around the world when they were considering the advice contained in the guidelines.

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