For makers of the swine flu vaccine, 2009 was a year to remember. By June, CSL Limited's annual profits had risen 63 percent over 2008. GlaxoSmithKine's 2009 earnings spiked 30 percent in the third quarter alone, to $2.19 billion. Roche made a stunning 12 times more in the second quarter of 2009 than of 2008. But in 2010, drug companies may get their comeuppance.
On Tuesday, the Council of Europe launched an investigation into whether the World Health Organization "faked" the swine flu pandemic to boost profits for vaccine manufacturers. The inquiry, held in Strasbourg, France, vindicates a worldwide movement of insiders, experts, and elected officials who accuse the United Nations organization of misleading the world into buying millions of unnecessary vaccines.
"I have never heard such a worldwide echo to a health political action," Dr. Wolfgang Wodarg, an epidemiologist who formerly led the health committee for the Council of Europe, said at Tuesday's hearing.
Dr. Ulrich Keil, director of the WHO's Collaborating Centre for Epidemiology, hammered his own organization and WHO's flu chief, Dr Keiji Fukuda, for "producing angst campaigns".
"With SARS, with avian flu, always the predictions are wrong...Why don't we learn from history?" Keil said. "It [swine flu] produced a lot of turmoil in the pubic and was completely exaggerated in contrast with all the really important matters we have to deal with in public health."
Last year the World Health Organization predicted that H1N1 could infect two billion and claim hundreds of thousands of lives, while President Obama's science advisers said the outbreak could infect up to 120 million Americans and kill 90,000. But thankfully, H1N1 turned out to be a mild flu. The type-A influenza has taken around 14,000 lives worldwide, according to World Health Organization numbers from January 22. The CDC said in December confirmed US deaths had reached 4,000, although it recently estimated that due to underreporting, the true death toll could be as high as 16,500 - a tragic sum, but less than half of what the CDC attributes to seasonal flu-related illness. In most of the northern hemisphere, hog flu has been on the decline for some about three months. New transmissions are largely contained to North Africa and South Asia, according to the WHO.
Signs swine flu wasn't much of a killer grew throughout 2009, but WHO and most domestic health agencies around the globe chose instead to man the war bugles at full volume. The result was that governments poured tens of billions of dollars into vaccines. The US alone has spent $2 billion on the drugs and has allocated $7.5 billion in supplemental spending for H1N1 preparedness.
With the disease basically over, however, countries are stuck with millions of unused doses. French and German governments have had to cancel millions of orders of the vaccines due to falling demand and late-breaking news that European health authorities had recommended twice the necessary dosage. The CDC has dealt with the glut in another way. It now says all Americans should go and get the shot - a shift from its earlier recommendation that at-risk groups such as the young, sick, pregnant, and nurses seek injections first. But why should everyone get a shot when that the disease is petering out?
On January 22, WHO issued a statement calling allegations that it irresponsibly stoked H1N1 fears, "scientifically wrong and historically incorrect." The statement defends figures WHO publicized on transmission rates, mortality, and the virulence of swine flu.
"The world is going through a real pandemic. The description of it as a fake is wrong and irresponsible. We welcome any legitimate review process that can improve our work."
At the hearing, WHO's flu director, Dr Keiji Fukuda, denied the accusations against WHO.
"Let me state clearly for the record - the influenza pandemic policies and responses recommended and taken by WHO were not improperly influenced by the pharmaceutical industry."
Previously, WHO had offered scant response to allegations of corruption, but deigned to defend itself after the Council of Europe meeting was announced. The public meeting to examine accusations against WHO was set up by the Parliamentary Assembly of the Council of Europe (PACE), which represents 800 million people in 47 countries. The Council's January 26 meeting involved WHO officials, European drug-makers, and medical experts. PACE's findings are expected to be announced January 29 and will likely be followed by an in-depth study and recommendations to European governments.
The hearing is just latest in a series of investigations into WHO's propriety, which also include a 2009 Danish Parliamentary review of links between WHO expert - Albert Osterhaus - and makers of the swine flu drugs. Russian lawmaker Igor Barinov has also started an inquiry into WHO's ties to H1N1 drug makers. In France, Health Minister Roselyne Bachelot was forced to a Paris court on January 4th over swine flu campaign irregularities - including ordering millions unnecessary vaccine doses. Demonstrations over statistical improprieties have taken place in Scotland and Canada.
Inquiries into WHO misdoing are likely to plunge deep into the statistical methods for data collection, however, it takes no expertise to see that health agencies' data about H1N1 was wildly misleading.
In addition to bad guesses about how many would die, a study released December 7 by the Harvard School of Public Health found that the WHO also estimated the deadliness of H1N1 to be 40 to 250 times higher than it was.
Proving the drug industry squeezed WHO into selling swine flu is very difficult to establish, but the string of clues which points to this corruption is not hard to follow.
Pandemic or just plain Panic?
Swine flu took center stage in June of 2009, when WHO declared H1N1 the first "pandemic" in 42 years. This move caught the eye of every health authority from Tampa to Timbuktu and revved drug company engines. But to do it, WHO had to redefine the word.
One month after swine flu appeared in April, WHO rewrote the definition of "pandemic". Under the new meaning, a pandemic does not need to cause high numbers of death or illness. A month after changing the definition, with just 144 people dead from H1N1, the flu was given the WHO's highest threat classification: a "stage-six pandemic alert". By comparison, the mildest 20th Century pandemic killed a million people.
Before the change, WHO had classified a pandemic as a disease that has "simultaneous epidemics worldwide with enormous numbers of deaths and illness." After the alteration, the organization's website stated that, "Pandemics can be either mild or severe in the illness and death they cause." In May, WHO spokesperson Natalie Boudou told CNN that the original definition was an error.
The Los Angeles Times writer Michael Fumento called the redefinition "bizarre". "Such a declaration could render the term "flu pandemic" essentially meaningless -- risking lethal public complacency if a bona fide one hits," Fumento wrote.
Tom Jefferson, Formerly a general practitioner in the British Army who has worked for the well-respected Cochrane Collaboration for 15 years, Jefferson asked in July: "Don't you think there's something noteworthy about the fact that the WHO has changed its definition of pandemic?"
"The WHO and public health officials, virologists and the pharmaceutical companies... They've built this machine around the impending pandemic," Jefferson told Der Spiegel, a German magazine with a weekly circulation of 1 million. "There's a lot of money involved, and influence, and careers, and entire institutions. And all it took was one of these influenza viruses to mutate to start the machine grinding."
Yet the WHO stands by its decision to label H1N1 a pandemic, citing geographic spread and the virus' novelty as its primary reasons. Moving ahead, Fukuda said his organization "will definitely consider whether we can define things better." But some participants in Tuesday's meeting wondered what the WHO is waiting for, since complaints have poured in from all sides.
The Associated Press reported on May 19, 2009, that China, Britain, Japan and other countries had urged WHO to "be very cautious about declaring the arrival of a swine flu pandemic, fearing that a premature announcement could cause worldwide panic and confusion."
Critics say what was needed was not a frightful label, but hard scientific data to show how many people were getting swine flu. But on July 10, the WHO quit tracking cases of infection and told governments they should stop testing for individual cases, ostensibly because the speed of H1N1's spread had already been confirmed.
"Rational scientific independent advice should be supreme, but there was an imperative behind this which was a financial one," said Paul Flynn, a parliamentary representative in the UK who spoke at the Council of Europe's hearing.
Corruption in Health Organizations?
Critics of the WHO say they promoted bad data to help drug makers get rich selling vaccines. This attack implies drug makers have a network of influence within the decision-making structure of the organization, a suggestion various officials confirm.
One high-level, long-term WHO employee who preferred to remain anonymous for job security, described the WHO as follows: "WHO is infested by corruption. There is big corruption, like the management of H1N1, and there is small corruption; and between the big and the small corruption there is [corruption] in all imaginable forms. Unfortunately, it's not only the WHO."
William Aldis, a retired senior WHO official who worked on the bird flu crisis, said in a Huffington Post article from September 24:
"I am concerned WHO's communications is corrupted by the fact they push the buttons in the public's brains that will raise the most funds. That is incompatible with what the organization should be doing: serving the public with technically correct factual information, pure and simple."
Louise Voller, a journalist at the Danish Daily Information newspaper, has reported that pharmaceutical companies are present at meetings of WHO experts, and, that purportedly independent scientists hired by the WHO are also consultants to the drug companies that make the vaccines.
On Tuesday, WHO's Fukuda insisted that its swine flu scientists' were not tainted by their private sector associations. The reason, he said, is that before each meeting, scientists are asked to declare all possible conflicts of interest. "These documents are gone over and examined. If there is some potential conflict of interest we go back and talk with them."
WHO was initially set up to rely on funding from UN member countries, in recent years, this source has been rapidly overtaken by "voluntary contributions", which are provided by the private sector, national governments, and NGOs. According to WHO's 2008-2009 budget, $958 million was supplied by the UN, while three times as much -- $3.2 billion -- came from voluntary donations.
Dr. Wodarg told the Council on Tuesday that the shift towards public-private partnership which began in earnest in 2001 puts WHO officials under extreme pressure.
"Already then there were very critical voices against the influence. [WHO's] administration is made of people not well paid who can't fight against the pay of people in and from the industry - they are simply swept aside...[private] influence is rampant and that is why we can't understand why the WHO we used to love...has become unrecognizable to us."
Whether or not WHO officials are being bought off, clearly, the capacity and incentive of drug makers to lean on science are enormous.
All US contracts for H1N1 vaccines went to just five companies: CSL Limited, Novartis, Sanofi Pasteur, GlaxoSmithKline, and MedImmune. All five also produced shots for either SARS or avian flu. When swine flu took full flight in the third quarter of 2009, these firms' earnings skyrocketed. But according to British MP, Paul Flynn, that was part of drug-makers plan.
Prior to winning any contracts, drug makers invested $4 billion in preparations for swine flu, he said. That investment may have gone to developing and patenting new, super-fast methods to create vaccines, such as using a bio-reactor to grow viruses, said Dr. Wolfgang Wodarg, former health expert for the Council of Europe. These patents were key to drug industry profits, since companies can charge much more for patented drugs than un-patented ones, Wodarg said.
"If you have a patent you can monopolize...and this is what industry did...The alternative is not to have vaccines patented...By decentralizing the production you could be as fast and you wouldn't have this small way you have to pass negotiating with one enterprise that has monopoly, or with four enterprises."
Food and Drug agencies in Canada, the UK, France, the US and elsewhere guaranteed vaccine manufacturers that they would be shielded from any lawsuits connected to the vaccines. This enabled companies to fast-track the testing process, reducing some trials to as little as 5 days.
Wodarg and others have also voiced concern that the hastily developed vaccines are not entirely safe. Adjuvanted vaccines, which contain a kind of immune booster shown to produce auto-immune responses in some children, were sold in parts of Europe and Canada, but banned in the US.
The private research group, Markets and Markets, estimated that the global, H1N1 vaccine market will be worth over $7 billion a year by 2011.
The incredible profits associated with outbreaks have sparked a wider shift in medicine from care to profit, according to Marcia Angell, M.D., former editor in chief of The New England Journal of Medicine and a senior lecturer at Harvard Medical School.
"Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself."
Angell reports that the drug industry spent around 14 percent of sales profits on research and development in 2000, while spending closer to 35 percent on "marketing and administration". How that expenditure breaks down is not public knowledge, but 35% comes out to a lot of money. For instance, Pfizer, GlaxoSmithKline, and Merck alone made $287 billion in 2007, according to the 2008 Pharma Report by IMS, a market intelligence firm.
The larger question begged by health agencies' bad data, and the media's dutiful reporting of it, is this: if fears are overstated every time there's a flu outbreak, when the public really does need a vaccine, who will believe the boys who cried wolf?
What's more, should the European investigations conclude that the WHO deliberately incited H1N1 paranoia to levels beyond reason in order to help drug makers, the implication is that both the private and public sectors need better oversight before being given any greater control over health care.