Pig Flu or Pig Fluke?


 

On January 26, 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. Held in Strasbourg, France, the inquiry comes in response to a growing movement of insiders, experts, and elected officials who have spoken out against what they see as bad science and fear-mongering aimed at persuading governments to spend billions of dollars on hastily-tested 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 WHO’s Collaborating Center 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.

Last year the World Health Organization predicted that H1N1 could infect 2 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 H1N1 turned out to be a mild flu strain. The type-A influenza is confirmed to have taken around 14,000 lives worldwide, according to WHO numbers from January 22. The Centers for Disease Control and Prevention (CDC) said in December that confirmed U.S. deaths had reached 4,000 although, due to under-reporting, it estimates the true death toll could be as high as 16,500. This is less than half of what the CDC attributes to seasonal flu-related illness. In most of the northern hemisphere, swine flu has been on the decline for around three months. New transmissions are largely contained to North Africa and South Asia, according to WHO.

Throughout 2009, WHO and most domestic health agencies, such as the CDC, ignored mounting signs that swine flu wasn’t much of a killer and the result was that governments poured tens of billions of dollars into vaccines. The U.S. alone has spent $2 billion on the drugs and has allocated $7.5 billion in supplemental spending for H1N1 preparedness.

All this boded well for drug makers. H1N1 appeared in April 2009 and by June CSL Limited reported annual profits had risen 63 percent above what they were from June 2007 to June 2008. Likewise, in the third quarter of 2009—around the time H1N1 contracts picked up steam—GlaxoSmithKline, which had been plummeting, enjoyed a 30 percent jump in earnings to $2.19 billion. Roche, the maker of Tamiflu, saw second quarter profits of 12 times what they were in the second quarter of 2009. And so on.

Now that the disease has petered out ahead of schedule, countries are stuck with millions of unused doses. French and German governments have cancelled millions of orders of the vaccines. The CDC now says all Americans should 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 the disease appears to be over?

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."

Previously, WHO had offered scant response to allegations of corruption, but defended itself after the Council of Europe meeting was announced. At the hearing, WHO’s flu director, 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."

 

Inquiries into WHO misdoing will likely require digging deep into their statistical methods for data collection. However, it takes no expertise to see that health agencies’ data about H1N1 was wildly misleading. Besides poor guesses on how many would get it, a study released December 7 by the Harvard School of Public Health found that the CDC predicted 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 7 to 9 times, the study found. Another study, done by CDC and published in the New England Journal of Medicine on December 31, found that swine flu was far more difficult to transmit than it had initially claimed.

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 were supposed to be released January 29, but have yet to appear. Initial results are likely to be followed by more in-depth study and recommendations to European governments.

The PACE hearing is the latest in a series of investigations into 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 WHO’s ties to H1N1 drug makers. Similar critiques have been leveled at domestic health authorities, which generally took their cues on how to deal with swine flu from 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.

The larger question raised 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? Further, if drug-makers have become so powerful they can skew the data of purportedly independent health authorities, as the evidence seems to suggest, then how far-reaching is their influence?

If the European Council’s investigations conclude that 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 when a disease should truly qualify as a "pandemic," and how dangerous a disease must become before a global vaccination campaign is advised. Proving that the drug industry paid WHO officials to sell swine flu will be difficult to establish, but the clues that point to this corruption are not hard to follow.

Pandemic Or Just Plain Panic?

Swine flu took center stage in June 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. In May, a month after swine flu appeared, WHO rewrote the definition of "pandemic." Under the new meaning, a pandemic does not need to cause high numbers of death or illness. Then, a month after changing the definition, with just 144 people dead from H1N1, the flu was given 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.

While some doctors warned WHO’s new definition might spark ill-founded panic, others, like epidemiologist Tom Jefferson, called it a political move. 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 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."

Dr. Wodarg said at the Council of Europe’s meeting 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’s novelty as its primary reasons. Moving ahead, Fukuda said his organization "will definitely consider whether we can define things better." Some participants in the meeting wondered what the WHO is waiting for, since complaints have long 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 that in the future, hard science needs to drive pandemic definitions and media campaigns. "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’s hearing. Unfortunately, good data on H1N1 does not exist, not even for a retrospective. On July 10, 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 being reported were of the H1N1 strain—as little as 3 percent in California. In response to questions about the CBS story, CDC media spokesperson 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 who people 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 1 in 4 Americans, had gotten swine flu. But with no flu-strain tests to cross-check, virtually anything that looks like a bad cold could end up in that total.

The Sky is Falling…Again

Considering the WHO and CDC’s abysmal track record foreseeing the severity of flu outbreaks, it’s surprising so many doctors bought their story. For example, nail-biting projections about SARS, the 2002-2003 respiratory disease, led the world to spend $80 billion to stop an emergence that ultimately killed just 800 people and made 8,000 sick. In 2005, avian, or bird flu, cost the U.S. government a billion dollars in vaccines and billions more in preparation for future outbreaks. WHO warned it could kill 150 million people, yet the ailment felled just 250 people worldwide.

But swine flu was different, right? Well, early on at least, 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 flus, a cursory look at history should have made the medical community more skeptical. For instance, the 1976 U.S. 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.

Perhaps doctors went along with 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 over-sold. 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, U.S., China, Taiwan, and India felt the media over-dramatized the H1N1 pandemic.

Some critics of the WHO go so far as to say they promoted bad data to help drug makers get rich selling vaccines. This attack implies drug makers possess a network of influence within the decision-making structure of the WHO, and perhaps even within domestic health agencies like the CDC. 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 last September: "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 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.

At the Strasbourg inquiry, 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."

The WHO was initially set up to rely on funding from UN member countries, but 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. WHO reports that only around 1 percent of these voluntary contributions come from the private sector, but the total of private influence may be obscured. For example, companies can donate to foundations or NGOs which support their interests. According to internal WHO emails received by the British Medical Journal and described in a February 17, 2007 article, Benedetto Saraceno, the director of WHO’s department of mental health and substance abuse, advised a patient group to accept money from GlaxoSmithKline and then pass it on to WHO in order to mask the money’s origins.

Dr. Wolfgang Wodarg told the Council of Europe that there has been dissent ever since the shift towards this public-private partnership began in earnest in 2001. "[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…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 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," to swine flu, Engdahl reports.

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 so far emerged from the investigation unscathed.

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 to this, Frieden had been the top health official in New York City and worked overseas for WHO. In both capacities, he was an active proponent of mass vaccinations against tuberculosis. Under Frieden’s direction, 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.

Likewise, 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. During the Bush presidency, Gerberding oversaw a drastic, multi-year revamping process in which dozens of CDC’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 that raises money for the CDC’s efforts through private donations. Whether or not money is altering the WHO and CDC’s data, clearly the capacity and incentive of drug-makers to lean on science is enormous.

Pandemic Profit

At the root of the entire case against H1N1 and health authorities lie the drug-makers who stand to gain most from global vaccination campaigns. All U.S. 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, showing an ongoing relationship to the issue. As stated, when the response to swine flu took full flight in the second and third quarters of 2009, these firms’ earnings skyrocketed. According to British MP Paul Flynn that was part of drug-makers plan.

Prior to winning any contracts, drug-makers invested four billion dollars in preparations for swine flu, Flynn said at the Council of Europe’s hearing. 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. Wodarg. These patents are key to drug industry profits, since companies can charge much more for patented drugs than un-patented ones. "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 U.S., 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 and others have voiced concerns 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 U.S.

The private research group, Markets and Markets, estimated that the global H1N1 vaccine market will be worth over $7 billion a year by 2011. Could some of this potential profit have been invested to buy influence at health agencies?

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, that is exactly what has happened—not just with swine flu, but with drug-based medicine in general. "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 U.S. Congress, the FDA, academic medical centers, and the medical profession itself."

Angell reports in The Truth About the Drug Companies: How They Deceive Us and What to Do About It that the drug industry spent around 14 percent of sales profits on research and development in 2000, compared to the some 35 percent it spent on "marketing and administration." How its "marketing" expenditure breaks down is not public knowledge, but 35 percent comes to a lot of money. In 2002, 10 drug companies in the Fortune 500 mademore 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.

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 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 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 two 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."

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 Center for Disease Control led the major study. 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 Austrian science journalist Jane Burgermeister who is suing the drug company Baxter for allegedly sending out around 160 pounds of seasonal flu vaccines with 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 website. Burgermeister believes she lost her job due to the lawsuit.

H1N1 is composed of flu strains from viruses found in birds, humans, and pigs from both the U.S. 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 been spawned at hog farms in the U.S., the Journal reported.

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Niko Kyriakou is a freelance journalist for various outlets, including American Prospect Online, Tom Paine.com, UPI, Inter Press Service, and others.