For makers of the swine flu vaccine, 2009 was a year to remember. By June, CSL Limited's profits rose 63 percent above 2008 levels, while in the third quarter of 2009 - just about the time H1N1 contracts picked up steam - GlaxoSmithKine enjoyed a 30 percent jump in earnings to $2.19 billion. Roche, the maker of Tamiflu, which prevents H1N1, saw second quarter profits leap to 12 times what they were in that quarter 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 (WHO) "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," said Dr. Wolfgang Wodarg, an epidemiologist who formerly led the health committee for the Council of Europe, at Tuesday's hearing.
Also present was Dr. Ulrich Keil, director of the WHO's Collaborating Centre for Epidemiology. Keil hammered his own organization and WHO 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 asked. "It [swine flu] produced a lot of turmoil in the pubic and was completely exaggerated " exaggerated" in contrast with all the really important matters we have to deal with in public health."
Last year the WHO 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 in the end, H1N1 turned out to be one of the milder flu strains on record. The type-A influenza is confirmed to have taken around 14,000 lives worldwide, according to WHO 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 ten straight weeks. New transmissions are largely contained to North Africa and South Asia, according to the WHO.
Throughout 2009, the WHO and domestic health agencies around the globe ignored mounting signs that swine flu wasn't much of a killer, choosing 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.
Now that the disease has petered out ahead of schedule, 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 appears to be over?
On January 22, the WHO issued a statement calling allegations that it irresponsibly stoked H1N1 fears, "scientifically wrong and historically incorrect." The statement defends figures the 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."
Previously, the WHO had offered scant response to allegations of corruption, but deigned to defend itself after the Council of Europe meeting was announced. At the hearing, the WHO's flu director, Dr. Fukuda, denied the accusations against the 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."
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. Established by various European nations in 1949 to promote human rights and the democratic rule of law, 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 PACE hearing is the latest in a series of investigations into the WHO's propriety, which also includes a 2009 Danish Parliamentary inspection of links between WHO expert, Albert Osterhaus, and makers of the swine flu drugs. Russian lawmaker Igor Barinov has also started an inquiry into the WHO's ties to H1N1 drug makers.
Similar critiques have been leveled at domestic health authorities as well, which generally took their cues on how to deal with swine flu from the WHO.
In France, Health Minister Roselyne Bachelot was forced to a Paris court on January 4 over swine flu campaign irregularities - including ordering millions of 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.
For example, a study released December 7 by the Harvard School of Public Health found that the CDC predicted that H1N1 mortality rates would be 80 to 500 times higher than they turned out to be - with the WHO doing only slightly better. The CDC also overshot the likelihood that pig flu causes serious illness by seven to nine times, the study found. Another study, done by the CDC itself and published in the New England Journal of Medicine on December 31, found that swine flu was far more difficult to transmit that it had initially claimed.
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?
Should the European Council's investigations conclude that the WHO deliberately incited H1N1 paranoia to help drug makers, it could spark reform of how infectious diseases are handled. The paramount questions experts will try to address are how dangerous a disease must become before a global vaccination campaign is advised, and when a disease should truly qualify as a "pandemic".
Proof of direct corruption may be difficult for the Council to establish, but the string of clues which points to this corruption - as befits the trail of a wild pig - is not hard to follow.
Pandemic or Just Plain Panic?
Swine flu took center stage in June of 2009, when the WHO declared H1N1 the first "pandemic" in 42 years. It was this label that caught the eye of every health authority from Tampa to Timbuktu, and which revved drug company engines. But to do it, the WHO had to redefine the word.
One month after swine flu appeared in April, the 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, the 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 web site stated, "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.
On Tuesday, the WHO's Fukuda backed that assertion, saying, "Severe death has never been part of WHO's pandemic [definition] - in earlier discussions it is often pointed out that severity may be high, but it has also been pointed out that they can be very low."
Moving ahead, Fukuda said his organization "will definitely consider whether we can define things better." Some participants wondered why the WHO hasn't already come up with a better definition, since complaints about the change have poured in from all sides.
The Associated Press reported on May 19, 2009, "China, Britain, Japan and other countries urged the World Health Organization on Monday to be very cautious about declaring the arrival of a swine flu pandemic, fearing that a premature announcement could cause worldwide panic and confusion."
Peter Gross, an infectious disease specialist with the Hackensack University Medical Center in New Jersey wrote that the WHO's new definition was fuzzy and might incite ill-founded panic. His September editorial in the British Medical Journal echoed epidemiologist Tom Jefferson. Jefferson, formerly a general practitioner in the British Army, who has worked for the well-respected Cochrane Collaboration for 15 years, 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 one million. "And 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."
The opinion given by Dr. Wodarg at Tuesday's meeting is that the definition change was designed to boost vaccine sales. "There is no other explanation for what happened. Which reasons could lead to those [WHO] decisions? I don't find any other explanation. It's not for health. And who profits? Why else would you change the definition?"
Yet, the WHO stands by its decision to label H1N1 a pandemic, citing geographic spread and the virus' novelty as its primary reasons. Critics however, say the redefinition wasn't based on science.
Critics say what was needed was not a frightful label, but hard scientific data to show how many people were getting swine flu.
"Rational scientific independent advice should be supreme, but there was an imperative behind this which was a financial one. I think what we need is evidence from industry that is more science-based," said Paul Flynn, a parliamentary representative in the UK, who presented at the Council of Europe's hearing.
Hard scientific data on how many people were getting swine flu might have been derived through rigorous testing, 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.
Following that advice, in mid-2009, the CDC decided laboratory tests to confirm whether patients had H1N1 were no longer necessary, and advised doctors to save resources and stop conducting them. A CBS news investigation found "overwhelming" evidence that despite the inflammatory estimations of the CDC, very few flu cases could truly be attributed to H1N1.
In response to questions about the CBS story, CDC media spokesman Jeff Dimond said, "We, as a matter of policy, do not comment on stories by other publications."
As of July 24, the CDC has used a statistical multiplier to come up with its total count of H1N1 cases - meaning it inflates confirmed cases using estimates about the number of infected people who never go to the doctor or are never tested during visits. In mid-December, using this model, CDC approximated that as many as 80 million, or some one in four Americans had gotten swine flu. But with no flu-strain tests to crosscheck, virtually anything that looks like a bad cold could end up in that total.
The Sky Is Falling ... Again
Considering the WHO's and the CDC's abysmal track record foreseeing the severity of flu outbreaks, it's surprising so many doctors bought their story. But then, early on, it was natural to suspect a nightmare scenario: a repeat of the Spanish flu.
Swine flu looks a lot like Spanish flu, which began in pigs and killed between 40 and 100 million people from 1918 to 1919. H1N1 shows three of the key traits which made the Spanish flu so dangerous: our immune systems aren't used to the virus, which is a new mutation; the flu can be passed from human to human; and, it has triggered immune responses in young people, not just the vulnerable elderly, according to Dr. Dawn Motyka, a vaccination expert in Santa Cruz, California.
Despite apparent similarities between the two flu's, a cursory look at history should have made the medical community more skeptical.
Characteristics akin to Spanish flu also sparked vaccination campaigns during the last two flu pandemics in 1957 and 1968, but neither of these outbreaks turned out to be major killers. The 1976 US swine flu epidemic - which refers to a domestic disease that kills a relatively high number of people - killed just one person. The hurried vaccine rollout however, killed 30 and cost the government $500 million in today's money. It also led hundreds more people to contract the crippling Guillian-Barre syndrome.
The trend toward overestimated contagions continued with SARS, the 2002-2003 respiratory disease. Nail-biting projections led the world to spend $80 billion to stop an emergence that ultimately killed 800 people and made 8,000 sick. In 2005, avian, or bird flu, cost the US government a billion dollars in vaccines and billions more in preparation for future outbreaks. The WHO warned it could kill 150 million people, yet the Hitchcockesque ailment felled just 250 people worldwide.
Perhaps, doctors went along with the sloppily-conceived H1N1 vaccination campaign because they tend to see vaccines as the single greatest lifesaver in modern medicine. The general medical view is that administering vaccines is a wise precaution, especially when dealing with a disease that could mutate into a mass killer. But critics say this concern has to be balanced against the loss of public confidence in health authorities should a disease end up a blowout, the risk of side-effects in recipients of scantily tested drugs and the enormous cost of vaccines.
In retrospect, more doctors acknowledge that swine flu was oversold. The Intelligence firm Synovate released a survey of physicians on January 26, 2010, which found that 61 percent of all physicians in the UK, France, Germany, Italy, Spain, US, China, Taiwan and India felt the media over dramatized the H1N1 pandemic.
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."
Similar comments have come from other WHO insiders, such as William Aldis, a retired senior official who worked on the bird flu crisis. In a Huffington Post article from September 24, Aldis characterized the WHO's handling of swine flu in the following way:
"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."
Aldis 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.”
While the 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 the WHO's 2008-2009 budget, $958 million was supplied by the UN, while three times as much - $3.2 billion - came from voluntary donations.
The WHO reports that only around 1 percent of these voluntary contributions come from the private sector, but the real total of private influence may be obscured. For example, companies can donate to foundations or NGOs which support their interests, thereby concealing the source of their contributions. According to internal WHO emails received by the British Medical Journal and described in a February 17, 2007, article, Benedetto Saraceno, the director of the WHO's department of mental health and substance abuse, advised a patient group to accept money from GlaxoSmithKline and then pass it on to the WHO in order to mask the money's origins.
Dr. Wodarg told the Council of Europe Tuesday that there has been dissent ever since the shift toward public-private partnership began in earnest in 2001.
"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."
Journalist and author William Engdahl has made it his mission to focus on one WHO expert in particular, Dr. Albert Osterhaus. Osterhaus sat on the WHO's Strategic Advisory Group of Experts (SAGE), which made strategic decisions regarding swine flu. Osterhaus is linked to "every major virus panic of the past decade, from the mysterious SARS ... [to] publicizing dangers of what he claimed was H5N1 Avian Flu," and even to swine flu, Engdahl reported.
On October 16, Science magazine said this about Osterhaus:
"For the past 6 months, one could barely switch on the television in the Netherlands without seeing the face of famed virus hunter Albert Osterhaus talking about the swine flu pandemic. Or so it has seemed. Osterhaus, who runs an internationally renowned virus lab at Erasmus Medical Center, has been Mr. Flu. But last week, his reputation took a nosedive after it was alleged that he has been stoking pandemic fears to promote his own business interests in vaccine development."
A Science blog from November 3 said Osterhaus had emerged from the investigation unscathed.
Russian lawmaker, Igor Barinov, chairman of the Duma Health Committee, recently launched an investigation into corrupt relations between the WHO and the pharmaceutical industry. If the investigation confirms allegations against the WHO, Barinov said Russia should withdraw from the WHO.
A similar scheme for potential corruption is present at the CDC. On June 8, just a few days before the WHO declared swine flu a pandemic, the CDC was taken over by Dr. Thomas Frieden. Prior, Frieden had been the top health official in New York City and worked overseas for the WHO. In both capacities, he was an active proponent of mass vaccinations against tuberculosis. Under Frieden's direction, the CDC announced a hefty vaccine-based response to the virus and outlined a distribution effort that some doctors say constitutes the largest vaccine experiment ever on pregnant women.
The former CDC director, Dr. Julie Gerberding, was hired by Merck in December to serve as president of the vaccine department. While in charge of the CDC, Gerberding came under intense criticism for bonuses she gave to employees who worked closely with her. And during the Bush presidency, Gerberding oversaw a drastic, multi-year revamping process at the CDC in which dozens of the organization's most respected experts quit their jobs.
The Washington Post reported on August 31, 2004, that a number of CDC officials thought the restructuring plan was "part of a larger administration effort to politicize science." In one organizational shift, vaccine safety was moved out of the domain of the National Immunization Program.
Robert A. Keegan, a high-level official, circulated a memo among the CDC's top leaders in which he revealed that employees who disagreed with official data had been "cowed into silence," the Post reported on March 6, 2005. Margaret Scarlett, who spent 15 years in the Centers' AIDS program before leaving in 2001, was quoted as saying, "Political ideology is being substituted for science."
A possible source of monetary influence by drug makers is the CDC Foundation, a nonprofit organization, which raises money for the CDC's efforts through private donations.
Whatever the means, clearly the capacity and incentive for 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 the response to swine flu took full flight in the second and third quarters of 2009, these firms' earnings skyrocketed. But according to British MP, Paul Flynn, that was part of the 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 bioreactor to grow viruses, said Dr. Wodarg. These patents were key to drug industry profits, since companies can charge much more for patented drugs than unpatented ones, Wodarg said.
"If you have a patent you can monopolize ... and this is what industry did: Invented a fast way to produce vaccines and had it patented, which is much more expensive ... 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. It's the economic dimension of the problem which we have to have in mind as we consider how this all happened."
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 five days.
Wodarg has also voiced concern that the hastily developed vaccines are not entirely safe. He is a fierce opponent of adjuvanted vaccines, which contain a kind of immune booster shown to produce autoimmune responses in some children. Adjuvanted vaccines were sold in parts of Europe and Canada, but are 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.
Such incredible profits 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 wrote a book called "The Truth About the Drug Companies: How They Deceive Us and What to Do About It." She reported 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 percent comes out to a lot of money.
In 2002, just ten drug companies in the Fortune 500 made more profits than all the other 490 companies put together, according to Angell. Pfizer, GlaxoSmithKline and Merck alone made $287 billion in 2007, according to the 2008 Pharma Report by IMS, a market intelligence firm.
In the words of Alyaksandr Lukashenka, president of the eastern European country Belarus, who spoke on Radio Free Europe last December: "I know very well what is going on in this super-corrupt, gangster circle of medicine producers. Today, [pharmaceutical companies] squeal like swine; tomorrow, perhaps, they'll purr like cats or moo like cows."
Dud Vaccines for Dud Diseases?
Perhaps the most sinister thing about the swine flu fluke is not that the disease has turned out to be a dud, but that the drugs themselves may be duds as well.
The Atlantic magazine ran a piece last November entitled, "Does the Vaccine Matter?" which concluded that medical data showing flu vaccines don't work has been squashed.
The Atlantic piece cites a rigorous study done by the Group Health Research Center in Seattle, which found seasonal flu vaccines to be ineffective. The study was marginalized to a little-read journal, The Atlantic said.
The December issue of The Lancet cites a master study which reviewed all previous flu vaccine studies. The report found, in the final assessment, no evidence that flu vaccines prevent death in children 2 and under - and advises they not be vaccinated.
As Dr. Wodarg put it: "Our children are vaccinated unnecessarily with the new vaccine. Scientifically this is a very big error and they don't deserve our trust when they go on like this."
But perhaps the oddest study concerning flu shots was done in Canada. The paper is still under peer review, yet the results were apparently leaked. According to a September 30 article in The Globe and Mail, the study found that Canadians who received last year's seasonal flu vaccine were twice as likely to get swine flu this year.
Well-respected researchers Dr. Gaston de Serres of Laval University and Dr. Danuta Skowronski of the British Columbia Centre led the major study for Disease Control. Ethan Rubinstein, who leads the adult infectious diseases department at the University of Manitoba, said the study has "a large number of authors, all of them excellent and credible researchers," and added that the "solid" research drew on a huge sample size of around 12 million people.
Scientists have no idea how seasonal flu vaccines and H1N1 might be connected.
One frightening possibility is suggested by the work of one of the most extreme voices in the budding movement of people who question the motives behind the swine flu vaccination plan.
Austrian science journalist Jane Burgermeister is suing the drug company Baxter for allegedly sending out about 160 pounds of seasonal flu vaccines containing bird flu-contaminated vaccine. Baxter's intent, she claims, was to instigate a pandemic. Burgermeister, who formerly wrote for the British Medical Journal, Nature and The Scientist, was recently fired from her job as European correspondent of the Renewable Energy World web site. Burgermeister believes she lost her job due to the lawsuit.
H1N1 is composed of flu strains from flu viruses found in birds, humans and pigs from both the US and Europe. One leading theory is that the international pig trade enabled the crossing of strains, but according to a Virology Journal article from November 24, how the H1N1 formed remains a mystery to science. The new strain of swine flu emerged last April, with the first cases found in Mexico. However, it is now widely believed to have spawned at hog farms in the US, the Journal reported.