Representatives of the World Health Organization and the European pharmaceutical industry today answered charges from the Council of Europe and the press on whether they had mishandled an outbreak of influenza last summer.

The declaration of the pandemic was “an incomprehensible action that cannot be supported by any evidence,” said Wolfgang Wodarg, a medical doctor with a specialisation in epidemiology and the former chair of the Sub-committee on Health of the Parliamentary Assembly of the Council of Europe. Wodarg was the leading signatory of a motion for investigation of the WHO by the Council of Europe, an intergovernmental body dedicated to the promotion of human rights and other issues.

The H1N1 virus (so-called swine flu) is not a genuine threat to public health, and this was widely known as early as April 2009, contended Wodarg, raising the concern that a pandemic was declared in June primarily to push massive government procurement of patented vaccines. These vaccines that were then rushed to market with inadequate testing might themselves pose a threat to public health, he said.

Wodarg called for an investigation to determine how this “dangerous nonsense” occurred.

But the current pandemic is “a scientifically well-documented event [and] not an arbitrary matter of wordsmithing or polemics,” countered Keiji Fukuda, the special adviser to the WHO director general on pandemic influenza. WHO is confident of integrity and scientific validity of its thinking, said Fukuda, adding this thinking was explained in a posting on the WHO website on 3 December.

They were speaking at a public hearing held 26 January in Strasbourg at the Council of Europe to discuss Wodarg’s motion.

At the hearing, Wodarg also argued that access to vaccines should not be restricted by patents, which “have no place in the area of vital medications for human beings.” Such drugs should be financed by taxation income, which Wodarg said is a human rights issue related to the right to health.

Pharma: Motion “Inappropriate”

“In our view the terms of this motion are inappropriate for those who understand how” vaccine manufacture works, said Luc Hessel, a representative of European Vaccine Manufacturers. An EVM press release on the hearing is available here [pdf].

The vaccine industry did what was asked of them by policymakers, said Hessel. This included major investments on their part to create the vaccines, as well as the donation of 160 million doses for use in developing countries. As to profit motive, Hessel said it was still too early to determine what kind of profit had been made by industry. And most purchasing agreements were made in the third quarter of 2009, after the declaration of the pandemic, so ex ante motivation is not there.

Also, he said, quick vaccine production does not mean insufficient testing. The industry had 60 years of experience and 10 years of preparation to make a pandemic vaccine, and it was from this technology base they were working.

Gigantic Misallocation of Public Health Resources?

Ulrich Keil, a professor and the director of the WHO Collaborating Centre for Epidemiology of the University of Münster (Germany) said the H1N1 virus had been known for decades, and that so-called Asian swine flu was carried back to the United States in the 1970s from Vietnam, at which point a huge vaccination campaign was initiated and then quickly stopped when it was realised the vaccine had more negative effects – including neurological symptoms such as paralysis – than the virus.

This “epidemic that never was” was borne of “overconfidence extrapolated from meagre evidence, personal agendas, and premature commitments,” said Keil. Obviously, he added, “those lessons were never learned.”

Hessel would not provide a clear answer to the question of whether or not they had known about the virus, but Fukuda said it was a new strain.

We are “presently witnessing a gigantic misallocation of public resources in health,” said Keil, as this issue is getting far more investment than non-communicable diseases, which are much more widespread killers.

One Council of Europe parliamentarian in the audience countered that as a defender of the population he preferred the cautionary approach. “If one person died without vaccine we’d be criticised,” he said, adding “and I have no shares in the pharma industry.”

And “history has shown that influenza pandemics can range in their impact, but that predicting what they will look like” at the beginning is “nearly impossible,” said Fakuda.

What was clear, said Fukuda, is that human antibodies against influenza were not reacting to the virus, and that there was a person-to-person spread with early cases causing severe respiratory illnesses and death.

A parliamentarian in the audience criticised the “over hysterical way the WHO responded to doubt” about its conclusions, “as though it couldn’t handle questions on its authorities.”

“I find it offensive that an organisation like yours would think you are beyond
reproach and beyond questioning,” he added.

Communication And Preventing Conflict

“It’s clear we can do better. The question is how do you do better?” said Fukuda, who added WHO was “under no illusions that this response was a perfect response.”

But “when you have a person with chest pain, you don’t typically wait until it’s very severe before we do something… this is the same approach.”

Wodarg said his “concerns have merely been strengthened” listening to WHO, and asked why the definition of a pandemic had been changed to remove the “seriousness” as a condition. Intellectual Property Watch covered this question yesterday (IPW, WHO, 25 January 2010).

The issue was also raised by an audience member that the pandemic – and potential problems in WHO handling – were exaggerated by a scandal-mongering media. This concern had also come up during the WHO Executive Board meeting, which ran from 18-23 January.

A representative of the UN press corps said the “WHO is the worst in terms of relations with the media. They are constantly derelict. We run after you constantly to get information. In defence of the media, we don’t have access to information.” If reporting has been inaccurate, he said, this is “largely attributable to the WHO’s aloofness and even silence.”

Fukuda said the WHO’s work was stressful and difficult but that he hoped “we can really improve our ability to give information and to give it in a timely way.”