A report released by the Social Health and Family Affairs Committee of PACE
, The handling of the H1N1 pandemic: more transparency needed
, was prepared by Paul Flynn, (United Kingdom, SOC).
It states that public confidence in health authorities, including the World Health Organization
(WHO) and the European Union, may plummet, leading to a disastrous situation “in the case of the next disease of pandemic scope - which may turn out to be much more severe than the H1N1 pandemic.”
The Parliamentary Assembly report also questions the competency of European Union and national health authorities. The report notes: “It is particularly troubled by some of the consequences of decisions taken and advice given leading to distortion of priorities of public health services across Europe, waste of large sums of public money, and also unjustified scares and fears about health risks faced by the European public at large.”
It urges WHO and other European institutions to share results of the H1N1 pandemic review process in “the most transparent and comprehensive manner possible” among all involved parties, including the “Council of Europe and its Parliamentary Assembly, WHO and competent bodies of the European Union, as well as national governments, the pharmaceutical industry, academia and civil society.”
While the report notes the WHO is the international authority on public health recommendations for its 193 member states, it states the organization “merits special attention” for its swine flu pandemic
declaration on June 11, 2009.
The new report notes some experts early on recognized the swine flu as doing “less harm” than other forms of the virus in previous years. It quotes Dr. Tom Jefferson, an epidemiologist with the Cochrane Collaboration
, in a July 21, 20009 interview with Der Spiegel, who stated: “the importance of influenza is completely overestimated. It has to do with research funds, power, influence and scientific reputations.”
Calling fears of the influenza phenomenon “exaggerated,” the report states the subsequent response to the outbreak was disproportionate. It went on to note many medical professionals and health experts were unable to distinguish between the H1N1 flu and flu-like symptoms, adding to a hysteria which made the pandemic worse than it actually was.
The report also notes a comment by Dr. Klaus Stoehr, in charge of WHO’s pandemic preparedness until 2007, who stated: "The pandemic planning I was involved with was always based on a severe public health event. [...] Moving to Phase 6 meant that we wanted governments [...] to kick in their plans whether they thought it was urgent or not".
Dr. Stoehr also believes WHO’s escalation of the pandemic to Phase 6 was also the result of the organization’s failure to read signs of the swine flu’s origin.
Flynn’ report also questions the actions of decision-makers who help sway public opinion. “In future situations posing a serious risk to public health, decision-makers should bear in mind that the precautionary principle can contribute to a general feeling of anxiety and unease in the population and can fuel the media in what becomes a cycle of fear mongering.”
Flynn also notes WHO’s changing its official definition of pandemic shortly before it declared the H1N1 pandemic, even though the influenza was presenting relatively mild symptoms. Declaration of the epidemic was only made possible after the definition was changed on May 4, 2009, which in effect lowered the declaration threshold.
The definition, prior to May 4, 2009 was worded as such: “An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in epidemics worldwide with enormous numbers of deaths and illness. With the increase in global transport, as well as urbanization and overcrowded conditions, epidemics due the new influenza virus are likely to quickly take hold around the world”.
WHO then changed the definition after this date on its website to read: “A disease epidemic occurs when there are more cases of that disease than normal. A pandemic is a worldwide epidemic of a disease. An influenza pandemic may occur when a new influenza virus appears against which the human population has no immunity …. Pandemics can be either mild or severe in the illness and death they cause, and the severity of a pandemic can change over the course of that pandemic”.
Shortly after the changed definition by WHO, Nathalie Boudou, a spokeswoman for the organization, justified the change by saying the old one was in “error.” According to a compilation of quotes by Dr. Jefferson that were presented at a March 29, 2010 public hearing of the Social, Health and Family Affairs Committee of the Parliamentary Assembly, Boudou stated the correct definition was that a “pandemic indicated outbreaks in at least two of the regions into which WHO divides the world, but has nothing to do with the severity of the illnesses or the number of deaths.”
Flynn suggests the changing of definitions and subsequent comments created confusion for both public health officials and the European public at large, especially at a time when the pandemic was imminent. He called the modified changes as being “highly inappropriate” and could be considered “non-transparent.”
The report then acknowledges the existence of the public-private partnership and the resulting conflicts of interests within WHO’s governing bodies. In particular, the public health sector uses a “systemic recruitment” of opinion leaders from specific agencies within the pharmaceutical industry.
Flynn states the possibility of the pharmaceutical industry directly influencing decisions and recommendations over H1N1 influenza as being one of the “central issues” of the ongoing debate.
He notes factors such as early contractual arrangements over vaccine delivery between pharmaceutical companies and member states in addition to the enormous profits made by companies as a result of the declared pandemic. This connection was brought to light earlier on Digital Journal
However, the primary suspicion in this regard, Flynn notes, is whether WHO’s advisory groups have professional connections with the pharmaceutical industry and the subsequent neutrality of those advisory members' advice.
Because of WHO’s refusal to release “names and declarations of interest of persons concerned,” Flynn suggests any research on the matter “depends entirely on the results of investigative journalism.”
WHO justifies its position by a need to protect the privacy of its experts and helping prevent them from coming under the influence and pressure of certain private companies or interest groups.
The Assembly report notes this attitude and is convinced of its justification in calling for full transparency on experts’ profiles.
Regarding the pharmaceutical industry’s role in the swine flu pandemic, the report notes the link between the industry, drug evaluation and authorization, and the degree of transparency associated with them.
According to information provided the Assembly, its report states: “all vaccines used during the pandemic were authorised according to the formal procedure followed by the European Medicines Agency (EMEA) although not all of them were clinically tested on vulnerable persons such as children.”
While the EMEA asserts the authorized vaccines and the adjuvants used were sufficiently tested, this assertion remains highly controversial within the medical community. For example, evidence shows at least one vaccine without adjuvants made by Sanofi-Pasteur (Panenza) received national authorization in some countries, such as France, and was not subjected to some of Europe’s rigid testing procedures.
The Assembly report also questions the risks involved for vaccine users and those on anti-flu medication, notably for the most vulnerable groups including women, children, and chronically ill persons. It notes that only patented products received authorization, resulting in a few companies monopolizing the vaccine market which consequently led to those companies selling the vaccine at much higher prices than seasonal vaccines produced in chicken eggs. These seasonal vaccines could have been readily produced by laboratories world-wide, using non-patented procedures.
Calling the development of a special vaccine targeted specifically for the H1N1 virus a “fast-track” procedure, the report questions whether the virus could have been treated with in-stock vaccines, noting that new virus variations are detected almost every year.
Adding to the concern over big pharma’s influence in epidemic declarations, the report notes the industry’s high profit levels as a result of the pandemic and vaccination campaigns.
JP Morgan estimates 2009 sales of H1N1 vaccines resulted in overall profits between 7 and 10 billion dollars for the pharmaceutical industry, according to the report. The report adds that Sanofi-Aventis released figures at the beginning of 2010 showing net profits of 7.8 billion Euros (+11), thanks to a “record year” of anti-flu vaccine sales.
In summary, the report notes outcomes from the pandemic have been dramatic and need to be critically examined by “public health authorities at all levels.” Some of these outcomes include possible influence by the pharmaceutical industry, transparency of expert identities and their decision-making process, communication of the pandemic to member state governments and the public at large, and the media’s role in that communication process.
It also notes the distortion of priorities, the waste of huge sums of public money, provocation of unjustified fear, creation of health risks through non-tested vaccines and medications, and the inappropriate timing and changing method of essential definitions related to pandemics.
The Parliamentary Assembly report ends by noting its contribution in the swine flu debate is “to provide a European platform where issues relating to democratic accountability and transparency of public decision-making processes in the health sector have been and will continue to be debated.”