Tuesday, June 15, 2010

WHO defends pandemic actions, says rules need tightening

Jun 10, 2010 (CIDRAP News) – The World Health Organization (WHO) replied at greater length today to recent criticism of the way it used science advisors in pandemic planning, defending its response to the H1N1 flu pandemic but allowing that its policies concerning transparency and relations with the pharmaceutical industry need strengthening.

Today's WHO statement largely reiterates points made by WHO Director-General Margaret Chan in a Jun 8 letter, but it offers more details and goes a step further by expressing regret that the agency did not list the industry connections of WHO advisors who helped develop pandemic guidance published in 2004 on the use of vaccines and antivirals.

The new statement was issued in response to an article and editorial published Jun 3 in BMJ (formerly the British Medical Journal) and a report by a committee of the Parliamentary Assembly of the Council of Europe (PACE), a human rights organization. The reports and editorial raised questions about possible conflicts of interest among the WHO's pandemic advisors because they had done paid work for pharmaceutical companies. The PACE committee report went further, branding the WHO's pandemic response an "unjustified scare" that led to wasteful spending.

Concerning potential conflicts of interest, the WHO notes that many leading experts who advise the agency have ties with industry, such as research funding, consulting work, and participation in industry-sponsored conferences. To guard against biased advice, the WHO requires expert advisors to declare their interests, and it assesses those interests to decide if any action is required, the statement says.

It adds, "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."

The BMJ critique focused heavily on the 2004 pandemic guidance, stating that the industry connections of three scientists who helped write the guidance were not listed in the document. The guidance was based on a meeting held in 2002.

"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," today's statement says. "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."

The BMJ critique also dwelt on the WHO's withholding of the names of members of the Emergency Committee it established last year to advise on its response to the pandemic. The article implied that the panel members may have conflicts of interest that slant their advice.

The WHO has said it has withheld the names to protect the members from commercial or political pressures. Today's statement provides more background on this rationale.

Whether to release the names was debated when the committee was set up under the International Health Regulations, the WHO said. The names of members of other advisory groups are released after their meetings. However, the SARS (severe acute respiratory syndrome) epidemic in 2003 showed that public health emergencies can cause considerable economic and social disruption, suggesting that "experts could well be lobbied or pressured for commercial or political reasons."

After considering the issues, the WHO decided to follow its usual practice of disclosing the names of experts after completion of the advisory group's work. But the committee has held a number of meetings over more than a year, rather than a single meeting like most advisory groups, so the release of names has been delayed.

The names of members and summaries of their declarations of interest will be issued after the pandemic is declared over, the WHO said. Meanwhile, "Procedures for revealing names of member of future Emergency Committees are under review."

Other points in today's statement, which is presented in a question-and-answer format, deal more with the substance of the WHO's pandemic guidance and decisions.

For example, the statement summarizes how the H1N1 virus differed from seasonal flu and met the criteria for a pandemic: it was genetically unique, it circulated in summer, it hit younger people, it crowded out other flu viruses, and antibodies to seasonal H1N1 flu did not protect people.

The WHO rejects the critics' assertion that it removed severity from its definition of a pandemic. In particular, it addresses a 2003 WHO document—often cited by critics—stating that a flu pandemic causes "enormous numbers of deaths and illnesses."

"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," the statement says.

The WHO also repeated Chan's flat rejection of the allegation that it declared a pandemic to boost the earnings of drug companies, saying no evidence for this has been found.

The statement also defends the agency's guidance on use of antivirals during the pandemic.

Source: http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/jun1010who.html

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