WHO Says Failure to Disclose Conflict of Interests of Pandemic Advisors Was an "Oversight"

June 08, 2010

June 8, 2010 (updated with links June 14, 2010) — The World Health Organization (WHO) committed an oversight when it failed to disclose conflicts of interest for scientists who have advised it on pandemic influenza policies, a spokesperson for the agency said today.

WHO collected so-called declarations of interest from the scientists in question, but never published them, agency spokesperson Gregory Hartl told Medscape Medical News.

"It was an oversight," said Hartl. "If we were using today's practices, we would have published the summary for the relevant interests. The way we handle [declarations of interest] is a work in progress."

Hartl's comments were in response to an article published June 4 in the British Medical Journal (BMJ) documenting the agency's failure to disclose conflicts of interest for its scientific advisors. The article's authors, BMJ features editor Deborah Cohen and journalist Philip Carter from the nonprofit, London-based Bureau of Investigative Journalism, write that this lack of transparency has fed a widespread conspiracy theory — namely, that WHO declared a "fake" pandemic to boost sales for pharmaceutical companies that manufacture antiviral drugs and the H1N1 vaccine.

A group called the Parliamentary Assembly of the Council of Europe (PACE) leveled the same criticisms at WHO in a report also issued June 4. PACE stated that WHO's handling of the H1N1 influenza pandemic has resulted in unjustified fears, "the waste of large sums of public money," and the possibility that the public will not heed agency recommendations the next time a pandemic strikes. The Council of Europe is a 47-member group distinct from the European Union.

In a letter to the BMJ that WHO released today, WHO Director-General Margaret Chan, MD, defended the integrity of her agency.

"At no time, not for 1 second, did commercial interests enter my decision making," Dr. Chan stated. She also said potential conflicts of interest are "inherent" in the relationship with public health agencies and for-profit businesses, and that WHO needs to establish and enforce "stricter rules of engagement with industry."

[Editor's Note: On June 10, WHO released this response to its critics.]

Industry observers have noted that neither the BMJ article nor the PACE report offer any evidence that anyone at WHO issued a recommendation or made a decision with an individual's or company's financial gain in mind.

WHO has convened a special review committee to investigate the possible influence that the private sector may have exerted on the agency and its committees. Dr. Chan asked the review committee, chaired by Harvey Fineberg, MD, PhD, president of the Institute of Medicine, to glean lessons from how WHO and the international community responded to the pandemic.

In a written statement released on June 4, Dr. Fineberg said his committee "welcomes the opportunity to learn from reports published today by the British Medical Journal and released by...the Parliamentary Assembly of the Council of Europe." Dr. Fineberg's committee is scheduled to deliver a final report to WHO in May 2011.

Critics Say Emergency Committee Should Not Operate in Anonymity

BMJ authors Deborah Cohen and Philip Carter assert that WHO drafted a series of plans to combat future influenza pandemics with the help of scientists who had financial ties to Roche and GlaxoSmithKline — manufacturers of the antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza). However, WHO did not disclose these links, according to Cohen and Carter.

The plans, which date back to 1999, included guidelines published in 2004 that recommended stockpiling antivirals in preparation for a pandemic. There were no conflict of interest statements for 3 contributing scientists who had received honorariums, consultancy fees, research support, and travel sponsorship from the 2 antiviral manufacturers, write Cohen and Carter.

Furthermore, the BMJ authors criticize WHO for not identifying the members of its Emergency Committee, which has advised the WHO director-general on the influenza pandemic. When Dr. Chan declared on June 11, 2009, that H1N1 disease activity had reached the full-blown pandemic level on the agency's pandemic scale, she based her decision on the committee's recommendation.

WHO has defended giving anonymity to the members of the committee for the sake of shielding them from outside influences, but Cohen and Carter point out that the agency does not hide the identity of members of other key committees, such as the Strategic Advisory Group of Experts on Immunization.

In her letter to the BMJ, Dr. Chan said WHO would release the names of the Emergency Committee members once their work is over, as the agency had intended all along. Furthermore, the special review committee investigating WHO's handling of the pandemic will have access to records of all Emergency Committee meetings.

WHO Did Not Exaggerate Pandemic's Severity, Secretary-General Says

The lack of transparency about the Emergency Committee ranks high on the list of complaints in the report released by PACE. It stated that committee members with conflicts of interest could have done vaccine manufacturers a favor by declaring that a pandemic was underway. This declaration triggered "sleeper contracts" for European nations to purchase prearranged quantities of vaccine, according to the report.

WHO made it easier to justify the declaration by redefining a pandemic, PACE stated. Before May 4, 2009, according to PACE, WHO's Web site said that "an influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in several, simultaneous epidemics worldwide with enormous numbers of deaths and illness." However, WHO removed the qualifying reference to "enormous number of deaths and illness" after it revised its pandemic preparedness plan. Now the agency Web site says that influenza pandemics "can be either mild or severe in the illness and death they cause."

Dr. Chan denied in her letter to the BMJ that WHO revised its definition of a pandemic "to accommodate a less severe event and thus benefit industry." The agency, she said, completed its current pandemic preparedness plan along with its definition of a pandemic in February 2009, before "a new strain of H1N1 was on the horizon."

In addition, WHO spokesperson Gregory Hartl told Medscape Medical News that the previous agency description of a pandemic with the reference to "enormous numbers of deaths and illness" was just that — a description, not an official definition.

"It's not a definition, but we recognize that it could be taken as such," said Hartl. "It was the fault of ours, confusing descriptions and definitions."

Although WHO eliminated disease severity as a defining feature of an influenza pandemic, the agency nevertheless stands accused of exaggerating the virulence of the H1N1 pandemic, which has killed fewer people than seasonal flu in the United States does on an annual basis. Dr. Chan said in her letter to the BMJ that when she declared a pandemic in June 2009, she noted that the number of deaths at that point was small and that WHO did not expect to see a sudden and dramatic jump in the number of severe or fatal infections.

"In every assessment of the pandemic," she stated. "WHO consistently reminded the public that the overwhelming majority of patients experienced mild symptoms and made a rapid recovery, even without medical treatment."

Pandemic Was Not a Fake, Says Department of Health and Human Services Spokesperson

WHO has not lacked for defenders as it catches flak from the European sector.

"WHO handled the H1N1 outbreak in a measured and appropriate way, and there was no indication that any of their decisions were influenced by industry," Bill Hall, a spokesperson for the US Department of Health and Human Services, told Medscape Medical News. "Their decisions were driven by the existing and evolving conditions using the best scientific information available at the time."

Hall also said it was "wrong and flat-out irresponsible" to call the outbreak a fake pandemic.

Others such as Michael Osterholm, PhD, MPH, director of the University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP), contend that public health agencies such as WHO cannot easily avoid the problem of conflict of interest because scientific experts often have ties to industry.

"Over the years there's been a small group of researchers who have concentrated in antiviral treatment and prevention for flu," the publication CIDRAP News recently quoted Dr. Osterholm as saying. "Why should it be surprising that they may have worked with drug companies on these drugs? To exclude them would be to exclude the universe of expertise."

Dr. Osterholm noted that he supported transparency and disclosure when conflicts of interest do arise.

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