Who influenced WHO?

By Jodie Humphries, Deputy Editor

Is it better to overestimate the threat of a virus and spend millions on vaccines that may not be needed, or make a misjudgment in the other direction and cause millions of unnecessary deaths?

“Many nations are nevertheless attempting to cancel pending orders for H1N1 vaccines”

In April of last year, the World Health Organization (WHO) was informed of human infections caused by a new H1N1 virus. The report was classified as being of 'immediate concern' because the genes contained in the virus were from animal influenza viruses, establishing that the virus was very different from the usual seasonal human influenza viruses.

On 11 June 2009, WHO announced that the virus would now be classed as a pandemic, because the virus had spread through 120 countries. It was predicted that the H1N1 virus would affect billions of people, and kill thousands. To date, there have been more than 14,000 laboratory-confirmed deaths worldwide.

Media speculation

In recent months, however, there has been speculation that due to WHO's ties with the pharmaceutical industry, the extent of H1N1 was exaggerated. It has been suggested that there was no need for WHO to call the virus a pandemic, an action that resulted in many countries changing their health priorities to accommodate the thousands of patient that were expected as a result. This, in turn, prompted governments to spend millions on contracts with drug companies to procure large quantities of H1N1 vaccine.

But, as argued by Dr. Keiji Fukuda, Special Advisor on Pandemic Influenza to the Director-General of WHO, "The H1N1 pandemic is not the same as seasonal influenza and differs in major respects. Large outbreaks occurred outside the usual season for influenza. The virus caused a striking and unusual pattern of severe illness and deaths in younger people, with many deaths caused by viral pneumonia: an especially aggressive form of the condition - and this pattern is not typically seen during seasonal influenza." Fukuda's arguments came on behalf of WHO at the Council of Europe hearing, The handling of the H1N1 pandemic: more transparency needed?, held in late January.

Ultimately, WHO's collaborations with the industry provide better access to high-quality and affordable medicines, vaccines and diagnostics. Medical interventions, including antiviral drugs, vaccines and diagnostic tests, have long been recognized for their role in mitigating the health impact of an influenza pandemic. In fact, WHO itself states that "pharmaceutical companies play an essential role in this regard and WHO has engaged with them to pursue its public health objectives."

As such, in responding to the pandemic, WHO drew on advice from a standing body of experts, the Strategic Advisory Group of Experts on Immunization (SAGE), which advises WHO on vaccine use. Members of SAGE are likewise required to declare all professional and financial interests, including funding received from pharmaceutical companies or consultancies or other forms of professional engagement with pharmaceutical companies. The names and affiliations of members of SAGE and of SAGE working groups are published on the WHO website, together with meeting reports and declarations of interest submitted by the experts.

Profits
Yet there can be no denying that the pharmaceutical industry has seen a rise in profits as a direct result of the H1N1 pandemic and the resulting sudden demand for vaccines. CSL Limited saw its profits rise 63 percent above 2008 levels by June 2009, while GlaxoSmithKline had benefited from a 30 percent jump by the third quarter. Roche, maker of the preventative drug Tamiflu, enjoyed a 12-fold leap in profits from the second quarter of 2008 to the same period in 2009.

What's more, and perhaps most critically, at the hearing Dr. Wolfgang Wodarg, a medical expert specializing in epidemiology and the former Chair of the PACE Sub-committee on Health, stated, "WHO basically held the trigger for the pandemic preparedness plans; they had a key role to play in deciding on the pandemic. Around 18 billion dollars was spent on this worldwide."

There is some debate over whether this is an issue of blame. At the hearing, and speaking on behalf of the pharmaceutical industry, was Dr Luc Hessel from the European Vaccine Manufacturers, who said, "The vaccine industry merely did what it was asked to do. The industry's role is to produce safe vaccines in a timely manner and respond to governments' requests. It is governed by stringent international health regulations and rigorous safeguards against conflict of interest. Decision-making regarding vaccine needs can only be based on the best available data at the time."

Nonetheless, swine flu has ended up being one of the most expensive public health crises ever, as - in the midst of a global recession - governments spent millions on vaccines that now may not be needed. And because of this, drug companies are reaping the benefits.

Far from over
Despite the fact that WHO says the pandemic isn't over yet, with more infections - and deaths - still to come, many nations are nevertheless attempting to cancel pending orders for H1N1 vaccines. France, for instance, which had ordered 90 million doses of the vaccine, more than was needed to inoculate its entire population of 60 million, has so far used only five million doses and now wants to cancel 50 million and sell the rest. Similarly, the Netherlands has a 19 million-dose order on sale to other countries, while Germany is in talks with manufacturers to halve its order of 50 million doses and sell off millions of others.

Switzerland, Spain and Britain are also considering giving away or selling the millions of doses that they have received or have on order, while the US, which has so far only distributed 160 million of the 251 million doses it purchased to doctors, hospitals and other healthcare providers, has yet to make a decision on whether it will have an overflow and what it will do with any surplus.

The main reason for the extra vaccine is simply that demand fell far short of what was originally expected. And now, after governments have spent billions of dollars on vaccines that are seemingly not needed, some politicians and health professionals are looking for hold someone accountable.

Dr. Fukuda, however, argues that, "WHO is confident of the scientific validity of its recommendations. The labeling of the pandemic as 'fake' is to ignore recent history and science and to trivialize the deaths of over 14,000 people and the many additional serious illnesses experienced by others."

He certainly has a point: while the number of cases might be declining, the fact remains that more 14,000 people died as a result of the virus. In the US alone, initial estimates put the projected death toll at 90,000, while in the UK the figure was expected to be 50,000. While the actual figures haven't reached these numbers, the effects of swine flu are still very real.

Was the seriousness of the swine flu pandemic exaggerated? Perhaps, but it would be wrong to jump to the conclusion that this was done to line the pockets of the world's drug-makers. On the contrary, the speedy development and delivery of vaccines could be one of the main reasons that the pandemic hasn't reached the dizzying heights of infection that were initially expected. After all, a pandemic remains a pandemic whether it results in 14,000 deaths or - like the Spanish Flu in 1918 - 50 million.