Jan 14, 2010 (CIDRAP News) – The World Health Organization (WHO) and vaccine makers from Europe today defended themselves against the charges of some European officials that the agency was improperly influenced by vaccine companies and exaggerated the threat of the pandemic H1N1 virus.
Keiji Fukuda, MD, special adviser to the WHO director-general on pandemic flu, told reporters at a press briefing that the WHO welcomes constructive criticism, but said charges of a "false pandemic" by a group of European officials led by Dr Wolfgang Wodarg, a German physician who chairs the Council of Europe's health committee, are "scientifically wrong and historically inaccurate."
Wodarg and 13 others charged in a proposed resolution that pharmaceutical company pressure on the WHO and member countries have led governments to waste healthcare resources and expose their citizens to insufficiently tested vaccines. The action comes as several European countries are cutting back on their vaccine orders because of weak demand, ebbing flu activity, and the need for just one dose per person.
Council debate set for Jan 26
In a related development, the European Vaccine Manufacturers (EVM), a trade group that represents companies such as GlaxoSmithKline, MedImmune, Novartis, and Sanofi, today in a statement rejected the Wodarg group's allegations. "EVM believes that the assertions in this motion are unfounded and result from a misunderstanding of the pandemic planning process and the collaboration between public and private sector partners," the group wrote.
Fukuda and the EVM both said their groups would participate in a Jan 26 Council of Europe debate on the issue. Fukuda said the WHO is currently working to determine what its participation in the debate entails and what information it will be expected to provide. "We're looking forward to participating," he added.
A journalist asked Fukuda if there was any truth to information from the Council of Europe that the WHO doesn't want a public debate on the pandemic topic. He said the charge is false. "The Council of Europe has not asked the WHO if it prefers open or closed door," he said. "WHO has offered no requirement of a closed hearing. We're expecting it to be open."
Despite government talks about scaling back vaccine orders, Fukuda said pandemic flu activity continues at elevated levels in a number of countries. The most intense activity is occurring in North Africa, southern Asia, and parts of eastern and southeastern Europe, he said.
"It remains too early to say the pandemic is over," he said, adding that experts aren't sure if the Northern Hemisphere will experience another wave in the winter or spring or what will happen when Southern Hemisphere countries enter their winter months.
The WHO's experts are still emphasizing the importance of the vaccine in addressing the pandemic threat, with pregnant women and people with chronic medical conditions still at great risk, Fukuda said.
WHO rejects four specific charges
At today's briefing, Fukuda countered each charge made in the Council of Europe resolution. Regarding the questions about whether or not the pandemic is real, "Here the answer is a clear 'yes'," he said. The WHO received its first notification of the new virus in late April, along with clinical information coming out of Mexico and the United States that the novel virus could cause severe, life-threatening infections. "This did send a strong warning that we should be ready for a pandemic," Fukuda said.
By April 29, nine countries had confirmed the novel virus, and by May 11 the virus was found in 74 nations and territories, he said, which is a pattern that defines a pandemic. "At this point, let's not play word games," Fukuda said.
A conservative estimate is that the virus has caused at least 13,000 deaths, he said, adding that the Wodarg group's charges are "somewhat disrespectful to the large numbers of illnesses and deaths and the people who have been working to protect others."
In response to charges that the WHO changed the definition of a pandemic, which may have led countries to overestimate its intensity, Fukuda said though pandemics can differ significantly, the basic idea of worldwide spread is the same. The WHO revised the definition of its pandemic levels in 1999, 2005, and 2009 to clarify them, but it never made severity part of the definition, he said.
Fukuda rejected charges that the WHO has hyped the pandemic. He pointed out that in June 2009 when Director-General Margaret Chan first announced that the world had reached the WHO's highest pandemic level, she emphasized the moderate severity of the disease. He added that the WHO has gone out of its way to say that the future course of the pandemic was uncertain. "This remains as true today as back then," he said.
"No one can afford to sit back and not work to reduce the impact. The WHO has been balanced and sober with its assessments," he said. "We have also pointed out that the severity can increase midstream."
Actions taken by governments, such as ordering vaccine stockpiles, have been the best in history, Fukuda said. "We don't know how they helped mitigate, but we believe they shouldn't be discounted."
Regarding the charge that the WHO was unduly influenced by the pharmaceutical industry, he said officials reached out to a wide variety of sectors. The input of vaccine industry representatives was vital for determining what could be done to expedite production and delivery of a vaccine, he said.
Since well before the pandemic, experts from outside the WHO have been required to declare their professional and financial interests and ties, Fukuda said. "This is shared with members and members of advisory groups. Any allegations of undeclared conflict of interest are investigated immediately by the WHO, and we respond appropriately," he said.
Vaccine group denies influence accusation
In its statement today, the EVM pointed out that governments have been working on pandemic preparedness plans for more than a decade and that other public health partners have been encouraged to respond to the risk of a pandemic.
The EVM said governments have asked the pharmaceutical industry to invest in vaccine research and development, conduct clinical studies, modify production facilities to make pandemic vaccine, and expand manufacturing capacity.
The pandemic declaration in the summer of 2009 called for clear action, the group wrote. "This demanded an unprecedented level of collaboration, involving WHO, national governments, health authorities, regulatory agencies, scientists, healthcare professionals, and private sector companies to facilitate a robust response and deliver the appropriate countermeasures."
Collaborations between outside groups such as vaccine companies and the WHO are governed by the International Health Regulations (IHR) and rigorous safeguards that the WHO outlined in a briefing in early December 2009.
Fukuda said that vaccine stockpiling decisions are left up to each individual country and that the WHO is not privy to the discussion between countries and companies. Vaccine availability is an important consideration, even in the prepandemic setting, he said.
Nations had to make their vaccine decisions before all the details about the virus were known, he said. "Decisions were made in a very sober light, and the actions taken were very prudent. Countries were trying to take all practical steps to minimize harm," Fukuda added.
Response review plans start to take shape
The WHO will review its pandemic response in the future and make the findings public, he said. "The self-review will be similar to any organization that is concerned with the quality of their work. There are lessons to be learned."
He said the IHR also require a review of how well the regulations were implemented during the pandemic. Fukuda added that the IHR review will look at the response of many groups that were involved in pandemic response, not just the WHO.
"We recognize that we need to use these opportunities to improve performance," he said. The WHO's executive board will discuss the assessments at its Jan 18 meeting.
Jan 13 CIDRAP News story "Health officials, experts reject 'false pandemic' charges"