Committee Nears Final Review Of WHO Performance On H1N1 Pandemic

The committee reviewing the World Health Organization’s response to the 2009 H1N1 pandemic and whether the international organisation was unduly influenced by the pharmaceutical industry in its response is working this week to formulate its final report.

Comments brought to the preliminary report, which exonerated the WHO of malfeasance, will be studied by the committee and the report will be edited before its expected presentation to the World Health Assembly in May.

The fourth and final meeting of the International Health Regulations (IHR) Review Committee is taking place from 28-30 March. Its final report should be presented at the 64th World Health Assembly from 16-24 May, and should be available as part of the documentation at the beginning of the assembly, according to a note [pdf] by the committee chair, Harvey Fineberg, president of the National Academies Institute of Medicine in Washington DC.

This comes before the next meeting of the WHO Open-Ended Working Group on Pandemic Flu Preparedness, to be held on 11-15 April.

The preview document [pdf] gives three preliminary conclusions and 15 recommendations. According to Fineberg, speaking at a press briefing yesterday, the committee heard between 12 and 20 presenters yesterday in a plenary meeting, and received between 20 and 30 additional comments to the preliminary documents. Although most of the comments were positive, some observers had questions and criticisms. Committee members will take the comments into account and formulate its final report, he said.

“The committee did its best to produce a report based on all the evidence we had before us,” Fineberg said. Extensive interviews were conducted, and a thorough assessment of documentary evidence and written material related to the IHR and the pandemic was carried out.

But the aim of the report did not appear to be to pillory the WHO. “We wanted the report to be constructive,” he said, bringing improvements to the response to public health emergencies, including pandemics
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The questions that came up were mostly clarifications of committee recommendations, he said. For example, there was a question about a committee recommendation urging wider use of vaccines against seasonal influenza.

The committee recommended that in accordance with each country’s assessment of its priorities, benefits and costs, vaccines for seasonal influenza should be used as a means of both protecting populations and extending the capacity for production in the time of a pandemic.

One comment responded to this, cautioning against immunisation for reasons other than the protection of the population at a particular time and against a particular disease. Otherwise, it said, this practice could in the long term, weaken public confidence in such recommendations, Fineberg said. Broadening the basis for vaccination of a population as a way to extend production capacity might be perceived as mixing a public health issue with a commercial issue, as it would significantly increase commercial opportunity.

Door Left Open on Undue Industry Influence

To a question about the alleged influence of the WHO by the pharmaceutical sector in the H1N1 pandemic management, Fineberg said that “It is impossible to prove a negative.” He added “we cannot prove that there was an absence of influence,” the committee could find no evidence for it, he said. There were no direct evidence, and no indirect evidence, only assertions “by some who believe it was the only plausible explanations,” he said.

“We believe alternative explanations for the actions taken” are more plausible. For example, the “power of the public health ethic to prevent the loss of life,” he said.

The fact that no evidence was found of inappropriate influence by industry in WHO decisions “does not preclude the fact [and] is entirely consistent” with the committee recommendation to strengthen the management of conflicts of interest. It is more a recommendation that serves good practice and prevention than it offers a remedy for errors in the past, he said.

Decisions about the virus, the need for a vaccine, the testing and distribution of vaccines were not based on unquestioned judgements, he said. “This was not an unthinking global acceptance of a commercial product without any examination.”

“This experience demonstrated that you cannot do very much in the midst of the emergency,” Fineberg said. How much could be done in advance? “The Committee’s initial view is that you could do more” but that needs to be discussed further, he said.

Chan Seeks Guidance for Next Pandemics

In remarks yesterday morning, WHO Director General Margaret Chan said the preview document had been read carefully by the WHO. “Since the beginning of this process, WHO has expected to receive a frank, critical, and evidence-based assessment of strengths and weaknesses in the response as the 2009 influenza pandemic evolved,” she said.

“We wanted guidance on what needs to change, at technical, managerial, policy, and even financial levels, to improve WHO leadership when the next pandemic inevitably occurs,” she said. “WHO needs to manage potential conflicts of interest much better. We are already doing so.”

However, she said that some of the committee recommendations “will be far easier to implement than others, as has been mentioned by some member states.” In particular, “weaknesses in the pandemic response that lie outside the direct authority and beyond the direct influence of WHO,” she said. “These are weaknesses that arise from larger systemic difficulties. In other words, from the way this world and its international systems work.”

Chan also said that the preview document exonerated the WHO of the allegation that “WHO declares a fake pandemic in order to line the pockets of industry.”

The assessment of the global response to the H1N1 pandemic, so-called Swine flu, was requested at the January 2010 WHO Executive Board meeting, and the IHR Review Committee was asked to review both the pandemic response and the functioning of the IHR. It started in April 2010 (IPW, Public Health, 15 April 2010).

The IHR (2005) is an international binding instrument that entered into force on 15 June 2007. Its stated purpose and scope are “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.”

H1N1 was the first global public health emergency since the IHR came into force.

The review had three objectives: Assess the functioning of the IHR, the ongoing global response to the pandemic H1N1, including the role of WHO, and identify lessons learned to strengthen preparedness and response for future pandemics and public health emergencies.

In September, Chan denied any pharmaceutical industry influence in the WHO response to the pandemic (IPW, Public Health, 28 September 2010).