“At no time, not for one second, did commercial interests enter my decision-making,” Director General Margaret Chan of the World Health Organization declared in a letter today defending the organisation’s increasingly scrutinised response to an outbreak of H1N1, or ‘swine flu.’

Research from the British Medical Journal (BMJ) and from the Council of Europe last week found that there had been conflicts of interest among the experts in whose hands declaring a pandemic rested (IPW, WHO, 7 June 2009). Chan’s letter is specifically in response to the BMJ story, and is addressed to the journal’s editors.

“Without question, the BMJ feature and editorial will leave many readers with the impression that WHO’s decision to declare a pandemic was at least partially influenced by a desire to boost the profits of the pharmaceutical industry,” she wrote.

But, she countered, the decision was based on “hard to bend” epidemiological criteria that are not changed by motive. She denied that the WHO had altered its definition of a pandemic in order to accommodate the H1N1 outbreak, saying the current pandemic preparedness plan was finalised in February 2009, before H1N1 was an issue. The first meeting of the pandemic

The current pandemic preparedness plan was published in April 2009, according to the WHO website. It replaced an earlier preparedness plan dated from 2005, available here [pdf].

The WHO has six phases of alert for possible influenza pandemics, in which ‘phase 6′ constitutes the official pandemic period. Movement between the phases has to do with the discovery of novel viruses and their geographic spread.

In the 2005 document, two footnotes to the definitions of pandemic phases explain that the distinction between phases 1 & 2 is based on the risk of human infection and that the distinction between phases 3, 4, and 5 is “based on an assessment of the risk of a pandemic.”

This risk assessment can include “rate of transmission, geographical location and spread, severity of illness, presence of genes from human strains… and/or other scientific parameters,” it says.

The 2009 document refines some of the phase definitions, and eliminates the footnotes.

WORLD HEALTH ORGANIZATION LETTER TO BMJ EDITORS

Below you will find a copy of the letter Dr Margaret Chan, Director-General of the World Health Organization (WHO) sent to the editors of BMJ in reference to their article on conflicts of interest at the WHO.

To the Editors,

In the editorial accompanying the feature on conflicts of interest at WHO ,, the author notes that it is “almost certainly true” that the mildness of the H1N1 pandemic, compared with the severity long expected from a virus like H5N1, has contributed to the current critical scrutiny of WHO’s decisions. As the editorial further states, this reality does not make it wrong to ask hard questions.

We fully agree. Good investigative journalism brings problems, and their potential consequences, into sharp focus and identifies the need for remedial action. Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and profit-driven industry. WHO needs to establish, and enforce, stricter rules of engagement with industry, and we are doing so. However, let me be perfectly clear on one point. At no time, not for one second, did commercial interests enter my decision-making.

I take issue with the assumption that WHO simply dismisses these hard questions as unfounded. In January 2010, I suggested that a Review Committee, an independent mechanism under the International Health Regulations, be used to evaluate WHO’s performance during the influenza pandemic. This recommendation was accepted by members of the WHO Executive Board, and the Committee’s work began on 12 April 2010. The Committee agreed to address criticism currently being levelled at WHO as part of its evaluation. I have publicly expressed my desire to see a critical, independent, and transparent assessment of WHO’s performance.

The implication that WHO provoked unjustified fear also needs to be addressed. The record is otherwise, and not a matter of interpretation. On 11 June 2009, when I announced the start of the pandemic, I drew attention to the fact that the worldwide number of deaths was small, and clearly stated that we did 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.

Concerning the members of the Emergency Committee that advised WHO on the pandemic, including phase changes, the names will be released when the Committee finishes its work, as has always been intended. Our decision not to make these names public was motivated by a desire to protect the experts from commercial or other influences. The members themselves welcomed this decision as a protective measure, and not as an attempt to veil their deliberations and decisions in secrecy. Records of all Emergency Committee meetings were kept, and these and all other documents pertaining to WHO’s pandemic decisions and actions have been placed at the disposal of the Review Committee.

Without question, the BMJ feature and editorial will leave many readers with the impression that WHO’s decision to declare a pandemic was at least partially influenced by a desire to boost the profits of the pharmaceutical industry. The bottom line, however, is that decisions to raise the level of pandemic alert were based on clearly defined virological and epidemiological criteria. It is hard to bend these criteria, no matter what the motive.

Accusations that WHO changed its definition of a pandemic in order to accommodate a less severe event (and thus benefit industry) are not supported by the facts. The current pandemic preparedness plan, which includes phase definitions, was finalized in February 2009 following two years of consultations. A new strain of H1N1 was neither on the horizon nor mentioned in the document.

A full record and timeline of events leading to the publication of the 2009 plan have been placed at the disposal of the Review Committee. Should this Committee decide that the current definition of a pandemic and the phases leading up to its declaration need to be tightened or otherwise revised, this will be another recommendation that we will welcome, and act on.

Dr Margaret Chan
Director-General
World Health Organization