Possible WHO-Industry Conflict Of Interest On Pandemic Flu Under Investigation

Global health authorities have been guilty of “grave shortcomings” in transparency and accountability to the public good in their handling of the pandemic influenza outbreak says a new draft resolution from the intergovernmental Council of Europe. A related investigative report from the British Medical Journal found evidence of “declarable financial conflicts of interests” among the experts advising the World Health Organization. But WHO denies any wrongdoing.

The draft resolution will be debated by all Council of Europe parliamentarians on 24 June in Strasbourg, France.

The draft resolution from the Parliamentary Assembly of the Council of Europe (PACE), available here [pdf], says the “highly defensive” WHO continues to hide information, including the names of members of the Emergency Committee that advised the declaration of a pandemic in June 2009 and their declarations of interest. Nor has the UN health agency been willing to re-evaluate its position on the health risks of the pandemic “despite the overwhelming evidence that the seriousness of the pandemic was vastly overrated.”

WHO’s actions caused a “distortion of priorities of public health services all over Europe” and unjustifiably provoked fear, health risks, and the waste of public funds, it says.

The resolution was authored by Paul Flynn, a British Member of Parliament acting as rapporteur for the Social Health and Family Affairs Committee within PACE.

The concerns were first raised in January when several parliamentarians accused WHO of “dangerous nonsense” and a waste of public funds that largely benefitted the vaccine manufacturing industry (IPW, Public Health, 26 January 2010). The resolution and the British Medical Journal (BMJ) report came out 4 June.

“Key guidance from WHO – on the need to stockpile antivirals, on the effectiveness of flu vaccines, and on pandemic flu in general – was authored by experts being paid by industry,” British Medical Journal Editor-In-Chief Fiona Godlee told PACE on 4 June in remarks available here [pdf].

“WHO’s credibility has been seriously damaged by these events,” she added.

A report by the BMJ with the Bureau of Investigative Journalism found that WHO guidelines for handling a pandemic originally drawn up in 1999 were prepared in collaboration with the European Scientific Working Group (ESWI), funded by Roche and other drug manufacturers and staffed by scientists who had participated in creating marketing material for Roche and also in trials testing the efficacy of a Roche-owned influenza treatment.

“We would strongly deny any claims of undue influence on WHO by the pharmaceutical industry,” WHO spokesperson Gregory Hartl told Intellectual Property Watch today, saying there is a “strong system of checks and balances in place to ensure that there is not any undue influence.”

Of course, the best experts in the world will be sought not just by the WHO but also by governments, pharmaceutical companies and other organisations, Hartl said, but the WHO has all of its expert advisers complete a declaration of interest and if necessary recuse themselves from discussions. It is in no one’s interest if things are not clear and above board, he said.

Hartl also took issue with questions about the nature of the pandemic. “To say that this is not a pandemic is historically inaccurate,” he said. There is “no doubt that it fills the criteria of a novel virus for which few if any human beings have any immunity and which has spread rapidly around the globe.”

The declaration of a pandemic automatically activated “sleeping contracts” between vaccine and medicine manufacturers and governments, says the draft PACE resolution. Many of these products have since gone to waste, it adds, citing evidence from France that – despite being able to cancel 50 of 94 million doses of vaccine initially ordered – tens of millions of doses are left unused as their expiration date approaches at the end of 2010. In addition to the potential waste of money, the draft resolution says that the vaccines that did make it to the market were inadequately tested and may themselves have posed a risk to public health.

This is not the first accusation of conflict of interest that the WHO has received in recent months. A draft document from an expert working group on research and development financing was leaked to a pharmaceutical lobby group in the fall (IPW, WHO, 9 December 2009), and an outpouring of concern on behalf of developing countries over WHO handling of several critical issue areas saw governments taking back control of processes previously in the hands of the secretariat at the May World Health Assembly (IPW, WHO, 21 May 2010 and 21 May 2010). Concerns about lack of transparency and flagging trust in the WHO secretariat are the oft-cited problems in all these cases.

The WHO is currently undertaking an expert review of its pandemic response, under its International Health Regulations. At its first meeting (IPW, WHO, 15 April 2010), Emergency Committee Chair John MacKenzie vehemently denied that the group was influenced by the pharmaceutical industry, and also said that the committee names (except his) are kept secret to avoid that possibility.

The BMJ report says questions are already being raised about the “incestuous approach” to choosing experts for this review, as 13 of the 29 are members of the International Health Regulations, which managed the pandemic flu response.

“Our review committee welcomes the opportunity to learn from [these] reports,” said Harvey Fineberg, its chair, in response to the BMJ and PACE releases. “These reports raise questions about potential, inappropriate influences on WHO decision-making … and, more generally, question practices employed by WHO to guard against conflict of interest among its expert advisers. These topics are among those that will be fully considered by our review committee.” The next meeting of the review committee is scheduled for 30 June-2 July.

The Emergency Committee last consulted with the WHO on 1 June, at which the director general said the names would be disclosed only once the groups work had been completed in order to “protect the integrity and independence” of its members, an approach the committee supported strongly, according to a WHO press release. This is standard WHO practice for expert committees, explained Hartl. It allows them to “work in more neutrality and objectivity” and to avoid outside influences.

The committee also on 1 June concluded the “most intense pandemic activity” appears to have passed and decided to have a further re-assessment in mid-July.

The PACE resolution says it is the right of European citizens and member states to be “fully informed” of decision-making processes, and called for improved cooperation among governments, better communication from public health authorities including with the media and a public fund to support independent research and expert advice.

With the winter flu season in the global South, developing countries need evidence-based data and a clarification of how industrialised countries handled the pandemic, said German Velasquez, senior advisor on health issues at the South Centre. This information is necessary to help them in deciding how to handle the pandemic, he said, adding as a result the South Centre is “closely following assessments and evaluations” such as those at the BMJ, national parliaments and the Council of Europe.