Talk about opening up a hornets’ nest.
As I wrote earlier this week, two new reports — one [PDF] from the Parliamentary Assembly of the Council of Europe and the other in the form of an investigative article in the British Medical Journal (BMJ) — have taken direct aim at the handling of the H1N1 pandemic by the World Health Organization (WHO).
The most troubling charges in the reports are that WHO let researchers with financial ties to pharmaceutical companies that sell antiviral drugs and influenza vaccines influence its pandemic-related decisions and recommendations.
“As an example,” wrote BMJ editor Fiona Godlee in an editorial that accompanied her journal’s investigative article, “WHO’s guidance on the use of antivirals in a pandemic was authored by an influenza expert who at the same time was receiving payments from Roche, the manufacturer of oseltamivir (Tamiflu), for consultancy work and lecturing. Although most of the experts consulted by WHO made no secret of their industry ties in other settings, WHO itself has so far declined to explain to what extent it knew about these conflicts of interest or how it managed them.”
As Godlee also pointed out, drug companies “have banked vast profits — $7 [billion] to $10 [billion] from vaccines alone according to investment bank JP Morgan. Given the scale of public cost and private profit, it would seem important to know that WHO’s key decisions were free from commercial influence.”
Defending WHO
Since the reports were released last Friday, many experts, incensed by such insinuations, have jumped to WHO’s defense — including Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research Policy.
“I think it’s actually reckless and irresponsible on the part of these organizations [the Parliamentary Assembly and BMJ] to say this,” Osterholm told me in a phone interview on Wednesday. “It really is akin to screaming fire in a crowded theater without there being any evidence of a fire.”
He then quickly challenged some of the key charges that the two reports make against WHO for its handling of the pandemic.
“First of all,” Osterholm said, “there was no purchase of vaccine tied to the declaration of the pandemic. It was all purchased beforehand. Second, the framework they are calling into question was actually a group of 22 science researchers and government leaders, not just the three that had the experience of working with Roche — which they had disclosed, by the way.”
Another charge suggested in both reports is that WHO, under the influence of the drug companies, changed its definition of pandemic, removing the phrase “causing enormous numbers of deaths and illnesses” so that it could declare a pandemic sooner than necessary.
Not so, said Osterholm. WHO began the process of revising its criteria for what constitutes a pandemic in 2005, he said, and it finalized that criteria in February 2009, two months before H1N1 became an issue.
There was a good reason, he added, for changing the criteria: The old way of measuring the severity of an influenza outbreak — primarily by number of deaths — was outdated. If the severity of an influenza outbreak is measured only by its death rate, then the H1N1 pandemic is far less severe than those that occurred in 1957 and 1968. In fact, it’s much less severe than an average seasonal influenza outbreak.
“But the average age of deaths in this pandemic was almost 35 years younger than that for seasonal flu,” said Osterholm. “So, in terms of number of years of life lost, this pandemic now exceeds the 1968 pandemic, and it’s virtually identical to the number of years of life lost to the 1957 pandemic.” (For a visual representation of this point, see the chart below.)
As for WHO taking advice from experts with financial ties to the pharmaceutical industry, Osterholm said he has no problem with that — as long as there’s full disclosure.
“There are very few people who have this expertise, and to not use them as subject-matter experts would be a major mistake,” he said. “You’d be accused of not using people because they have a financial consideration.”
Needed: more transparency
Jeffrey Kahn, director of the University of Minnesota’s Center for Bioethics, agrees. “You need expertise to provide expert opinion, and people who have expertise often have some kind of connection to industry,” he told me.
But, added Kahn, it’s not clear yet that WHO handled this particular issue in the most trust-inducing way. “We should require transparency so that the entity — WHO in this case — knows what particular influences the experts may have,” he said. “And then there is some obligation on the part of the entity to disclose that to the public.”
On Tuesday, Dr. Margaret Chan, WHO’s director-general, sent a letter to the editors of the BMJ, in which she acknowledges that WHO “needs to establish, and enforce, stricter rules of engagement with industry.” She also insists that “[a]t no time, not for one second, did commercial interest enter my decision-making.”
The names of the members of the Emergency Committee that advised WHO on the pandemic will be released, she added, when that committee finishes its work. She re-emphasized that their names have been withheld in order to protect them “from commercial or other influences.”
WHO has begun its own review of the decision-making process that led up to its declaration of the H1N1 pandemic. All sides seem to be welcoming this action. As Godlee wrote in her editorial: WHO’s “credibility has been badly damaged. Recovery will be fastest if it publishes its own report without delay or defensive comment; makes public the membership and conflicts of interest of its emergency committee; and develops, commits to, and monitors stricter rules of engagement with industry that keep commercial influence away from its decision making.”
If you want to read more on this dispute (in addition to the documents linked to above), Nature News has published a critical review of the reports. And Medpage Today has its own long review, which also includes the voices of critics, although you’ll have to register first to read the entire article.
UPDATE: WHO has published its own detailed response to the reports here.
