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 WHO scandal - major funding by Big Pharma
Mega Corruption Scandal At The WHO
By F. William Engdahl

WHO's 'Mr Flu' = Holland's Albert Osterhaus - has deep ties to pharma industry.

The UK Pharma Giant GlaxoSmithKline is at the heart of the WHO scandals of influence peddling.



The man with the nickname "Dr Flu", Professor Albert Osterhaus, of the Erasmus University in Rotterdam Holland has been named by Dutch media researchers as the person at the center of the worldwide Swine Flu H1N1 Influenza A 2009 pandemic hysteria. Not only is Osterhaus the connecting person in an international network that has been described as the Pharma Mafia, he is THE key advisor to WHO on influenza and is intimately positioned to personally profit from the billions of euros in vaccines allegedly aimed at H1N1.

Earlier this year the Second Chamber of the Netherlands Parliament undertook an investigation into alleged conflicts of interest and financial improprieties of the well-known Dr. Osterhaus. Outside of Holland and the Dutch media, the only note of the sensational investigation into Osterhaus' business affairs came in a tiny note in the respected British magazine, Science.

Osterhaus's credentials and expertise in his field were not in question. What is in question, according to a short report published by the journal Science, are his links to corporate interests that stand to potentially profit from the swine flu pandemic. Science carried the following brief note in its October 16 2009 issue about Osterhaus:

Quote:
" 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. As Science went to press, the Dutch House of Representatives had even slated an emergency debate about the matter."


On November 3, 2009 it appeared that Osterhaus emerged with at least the damage somewhat under control. An updated Science blog noted,

Quote:
"The House of Representatives of the Netherlands today rejected a motion asking the government to sever all ties with virologist Albert Osterhaus of Erasmus Medical Center in Rotterdam, who had been accused of conflicts of interest in his role as a government adviser. But Dutch health minister Ab Klink, meanwhile, announced a "Sunshine Act" compelling scientists to disclose their financial ties to companies."


The Minister, Ab Klink, reportedly a personal friend of Osterhaus, subsequently issued a statement on the ministry's website, claiming that Osterhaus was but one of many scientific advisers to the ministry on vaccines for H1N1, and that the Ministry "knew" about the financial interests of Osterhaus. Nothing out of the ordinary, merely pursuit of science and public health, so it seemed.

More careful investigation into the Osterhaus Affair suggests that the world-renowned Dutch Virologist may be at the very center of a multi-billion Euro pandemic fraud which has used human beings in effect as human guinea pigs with untested vaccines and in cases now emerging, resulting in deaths or severe bodily paralysis or injury.

The 'Bird Shit Hoax'

Albert Osterhaus is no small fish. He stands at the global nexus of every major virus panic of the past decade from the mysterious SARS deaths in HongKong, where current WHO Director Margaret Chan got her start in her career as a local health official. According to his official bio at the European Commission, Osterhaus was engaged in April 2003, at the height of the panic over SARS (Severe Acquired Respiratory Syndrome) in investigation of the Hong Kong outbreak of respiratory illnesses. The EU report states, "he again showed his skill at moving fast to tackle a serious problem. Within three weeks he had proved that the disease was caused by a newly discovered coronavirus that resides in civet cats, other carnivorous animals or bats."

Then Osterhaus moved on as SARS cases vanished from view, this time publicizing dangers of what he claimed was H5N1 Avian Flu. In 1997 he had already began (sic) sounding the alarm following the death in Hong Kong of a three-year-old who Osterhaus learned had had direct contact with birds. Osterhaus went into high gear lobbying across Holland and Europe claiming that a deadly new mutation of avian flu had jumped to humans and that drastic measures were required. He claimed to be the first scientist in the world to show that H5N1 could be transferred into humans.

In a BBC interview in October 2005 on the danger of Avian Flu, Osterhaus declared, "if the virus manages indeed to, to mutate itself in such a way that it can transmit from human to human, then we have a completely different situation, we might be at the start of the pandemic." He added, "there is a real chance that this virus could be trafficked by the birds all the way to Europe. There is a real risk, but nobody can estimate the risk at this moment, because we haven't done the experiments." It never did manage to mutate, but he was ready to "do the experiments," presumably for a hefty fee.

To bolster his frightening pandemic scenario, Osterhaus and his lab assistants in Rotterdam began assiduously assembling and freezing samples of, well, bird shit, in an attempt to build a more scientific argument. He claimed that at certain times of the year up to 30% of all European birds acted as carriers of the deadly avian virus, H5N1. He also claimed that farmers working with hens and chickens were then exposed. Osterhaus briefed journalists who dutifully noted his alarm. Politicians were alerted. He wrote papers proposing that the far away deaths in Asia from what he termed H5N1 were coming to Europe, presumably on the wings or in the innards of deadly sick infected birds. He claimed that migratory birds were carrying the deadly new disease as far west as Rügen and Ukraine. He conveniently ignored the fact that birds do not migrate east to west but rather north to south.

Osterhaus' Avian Flu alarm campaign really took off in 2003 when a Dutch veterinary doctor became ill and died. Osterhaus claimed the death was from H5N1. He convinced the Dutch government to order slaughter of millions of chickens. Yet no other infected persons died from the alleged H5N1. Osterhaus claimed that that was simply proof of the effectiveness of the preemptive slaughter campaign.

Osterhaus claimed that bird feces were the source, via air bombardment or droppings, onto populations and birds below. That was the vehicle for the spread of the deadly new Asian strain of H5N1 he insisted.

There was only one problem with the now voluminous frozen samples of diverse bird excrement he and his associated had collected and frozen at his institute. There was not one single confirmed example of H5N1 virus found in any of his samples. At a May 2006 Congress of the World Organization for Animal Health (OIE), Osterhaus and his Erasmus colleagues were forced to admit that in testing 100,000 samples of their assiduously saved bird feces, they had discovered not one single case of H5N1 virus.

At a WHO conference in Verona in 2008 titled "Avian influenza at the Human-Animal Interface," in a presentation to scientific colleagues undoubtedly less impressed by appeals to pandemic emotion than the non-scientific public, Osterhaus admitted that "A proper risk assessment of H5N1 as the cause of a new pandemic cannot be made with the currently available information." By then, however, his sights were already firmly on other possible pandemic triggers to focus his vaccination activities.

Swine Flu and WHO corruption

When no mass wave of human deaths from Avian Flu materialized and after Roche, maker of Tamiflu and GlaxoSmithKline had banked billions of dollars in profits from worldwide government stockpiling of their dangerous and reportedly ineffective antiviral drugs, Tamiflu by Roche, and Relenza by GlaxoSmithKline, Osterhaus and other WHO advisers turned to other greener pastures.

By April 2009 their search seemed rewarded as La Gloria, a small Mexican village in Veracruz, reported a case of a small child ill with what had been diagnosed as "Swine Flu" or H1N1. With indecent haste the propaganda apparatus of the World Health Organization in Geneva went into gear with statements from the director-general Dr Margaret Chan, about a possible danger of a global pandemic.

Chan made such irresponsible statements as declaring "a public health emergency of international concern." The further cases of outbreak at La Gloria Mexico were reported on one medical website as, "a 'strange' outbreak of acute respiratory infection, which led to bronchial pneumonia in some pediatric cases. According to a local resident, symptoms included fever, severe cough, and large amounts of phlegm."

Notably those were symptoms which would make sense in terms of the proximity of one of the world's largest pig industrial feeding concentrations at La Gloria owned by Smithfield Farms of the USA. Residents had picketed the Smithfield Farms site in Mexico for months complaining of severe respiratory problems from the fecal waste lagoons. That possible cause of the diseases in La Gloria apparently did not interest Osterhaus and his colleagues advising the WHO. The long-awaited "pandemic" that Osterhaus had predicted ever since his involvement with SARS in the Guandgong Province of China in 2003, was now finally at hand.

On June 11, 2009 Margaret Chan of WHO made the declaration of a Phase 6 "Pandemic Emergency" regarding the spread of H1N1 Influenza. Curiously in announcing it, she noted, "On present evidence, the overwhelming majority of patients experience mild symptoms and make a rapid and full recovery, often in the absence of any form of medical treatment." She then added, "Worldwide, the number of deaths is small; we do not expect to see a sudden and dramatic jump in the number of severe or fatal infections."

It later was learned that Chan acted, following heated debates inside WHO, on the advice of the scientific advisory group of WHO, or SAGE, the Strategic Advisory Group of Experts. One of the members of SAGE at the time and today was Dr. Albert "Mr Flu" Osterhaus.

Not only was Osterhaus in a key position to advocate the panic-inducing WHO "Pandemic emergency" declaration. He was also chairman of the leading private European Scientific Working group on Influenza (ESWI), which describes itself as a "multidisciplinary group of key opinion leaders in influenza [that] aims to combat the impact of epidemic and pandemic influenza." Osterhaus' ESWI is the vital link as they themselves describe it,
Quote:
"between the World Health Organization (WHO) in Geneva, the Robert Koch Institute in Berlin and the University of Connecticut, USA."


What is more significant about the ESWI is that its work is entirely financed by the same pharma mafia companies that make billions on the pandemic emergency as governments around the world are compelled to buy and stockpile vaccines on declaration of a WHO Pandemic. The funders of ESWI include H1N1 vaccine maker Novartis, Tamiflu distributor, Hofmann-La Roche, Baxter Vaccines, MedImmune, GlaxoSmithKline, Sanofi Pasteur and others.

Not to lose the point, the world-leading virologist, official adviser on H1N1 to the governments of the UK and Holland, Dr Albert Osterhaus, head of the Department of Virology at the Erasmus Medical College of Rotterdam, also sat on the WHO's elite SAGE and served as chairman at the same time of the pharma industry-sponsored ESWI, which in turn urged dramatic steps to vaccinate the world against the grave danger of a new Pandemic they insisted could rival the feared 1918 Spanish Flu pandemic.

The Wall Street bank, JP Morgan, estimated that in large part as a result of the WHO pandemic decision, the giant pharma firms that also finance Osterhaus' ESWI work, stand to reap some ¤7.5 to ¤10 billion in profits.

A fellow member of WHO's SAGE is Dr Frederick Hayden, of Britain's Wellcome Trust and reportedly a close friend of Osterhaus. Hayden also receives money for "advisory" services from Roche and GlaxoSmithKline among other pharma giants involved in producing products related to the H1N1 panic.

Chairman of WHO's SAGE is another British scientist, Prof. David Salisbury of the UK Department of Health. He also heads the WHO H1N1 Advisory Group. Salisbury is a robust defender of the pharma industry. He has been accused by UK health citizen health group One Click of covering up the proven links between vaccines and an explosive rise in infant autism as well as links between the vaccine Gardasil and palsy and even death.

Then on September 28, 2009 the same Salisbury stated, "There is a very clear view in the scientific community that there is no risk from the inclusion of Thiomersal." The vaccine being used for H1N1 in Britain is primarily produced by GlaxoSmithKlilne. It contains the mercury preservative Thiomersol. Because of growing evidence that Thiomersol in vaccines might be related to autism in children in the United States, in 1999 the American Academy of Pediatrics and the US Public Health Service called for it to be removed from vaccines.

Yet another SAGE member at WHO with intimate financial ties to the vaccine makers that benefit from SAGE's recommendations to WHO is Dr. Arnold Monto, a paid consultant to vaccine maker MedImmune, Glaxo and ViroPharma.

Even more, the meetings of the "independent" scientists of SAGE are attended by "observers" who include, yes, the very vaccine producers GlaxoSmithKline, Novartis, Baxter and company. One might ask if the SAGE are supposed to be the world's leading experts on flu and vaccines, why they would ask the vaccine makers to sit in.

In the past decade the WHO, in order to boost funds at its disposal entered into what it calls
Quote:
"public private partnerships."
Instead of receiving its funds solely from member United Nations governments as its original purpose had been, WHO today receives almost double its normal UN budget in the form of grants and financial support from private industry. The industry? The very drug and vaccine makers who benefit from decisions like the June 2009 H1N1 Pandemic emergency declaration. As the main financiers of the WHO bureaucracy, naturally the Pharma Mafia and their friends receive what has been called "open door red carpet treatment" in Geneva.

In an interview with Der Spiegel magazine in Germany, epidemiologist Dr. Tom Jefferson of the Cochrane Collaboration, an organization of independent scientists evaluating all flu related studies, noted the implications of the privatization of WHO and the commercialization of health:

Quote:
"one of the extraordinary features of this influenza -- and the whole influenza saga -- is that there are some people who make predictions year after year, and they get worse and worse. None of them so far have come about, and these people are still there making these predictions. For example, what happened with the bird flu, which was supposed to kill us all? Nothing. But that doesn't stop these people from always making their predictions. Sometimes you get the feeling that there is a whole industry almost waiting for a pandemic to occur.

SPIEGEL: Who do you mean? The World Health Organization (WHO)?

Jefferson: The WHO and public health officials, virologists and the pharmaceutical companies. They've built this machine around the impending pandemic. 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...


When asked if the WHO had deliberately declared the Pandemic Emergency in order to create a huge market for H1N1 vaccines and drugs, Jefferson replied,

Quote:
"Don't you think there's something noteworthy about the fact that the WHO has changed its definition of pandemic? The old definition was a new virus, which went around quickly, for which you didn't have immunity, and which created a high morbidity and mortality rate. Now the last two have been dropped, and that's how swine flu has been categorized as a pandemic."


Conveniently enough, the WHO published the new Pandemic definition in April 2009 just in time to allow WHO, on advice of SAGE and others like Albert "Dr Flu" Osterhaus and David Salisbury, to declare the mild cases of flu dubbed H1N1 Influenza A to be declared Pandemic Emergency.

In a relevant footnote, the Washington Post on December 8 in an article on the severity, or lack of same, of the world H1N1 "pandemic" reported that,
Quote:
"with the second wave of H1N1 infections having crested in the United States, leading epidemiologists are predicting that the pandemic could end up ranking as the mildest since modern medicine began documenting influenza outbreaks."


Russian Parliamentarian and chairman of the Duma Health Committee, Igor Barinow has called on the Russian Representative to WHO in Geneva to order an official investigation into the growing evidence of massive corruption of the WHO by the pharmaceutical industry.
Quote:
"There are grave accusations of corruption within the WHO," said Barinow. "An international commission of inquiry is urgently required."


Bibliography and footnotes for the research that went into this article can be found at the end of the article - see original source at the link below.

http://www.rense.com/general88/megawho.htm

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Wed Dec 09, 2009 8:10 am
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Post Re: WHO scandal - major funding by Big Pharma
Why does this not surprise me, thanks for posting Ruts

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Post Re: WHO scandal - major funding by Big Pharma
Swine Flu Gate: Is Virologist Albert Osterhaus the Ringleader?

Thursday, 03 December 2009 12:56

According to Russian, Danish and now Swedish newspapers, the Svenska Dagbladet, many of the "independent experts" who sit on important WHO committees and who were instrumental in the fake swine flu scare have financial links with the pharmaceutical industry that stand to make billions from the scam.

http://www.svd.se/nyheter/inrikes/artikel_3866171.svd

Albert Osterhaus, a professor for virologie at Erasmus University in The Netherlands, and a key advisor of WHO and EU, is under investigation for having concealed slush funds from pharmaceutical companies, according to Polskaweb.

Polskaweb reports a Dutch parliamentary committee of inquiry has been launched into the connection between the large sums of money paid by big pharma into Osterhaus' private bank accounts and his role in ratcheting up the swine flu scare to allow a pandemic level 6 declaration – something which, in turn, has allowed big pharma to reap huge profits through the sale of toxic pandemic vaccines.

snip

But Osterhaus appears to have financial links not just to Roche but also to GSK, Aventis and Baxter.

The Dutch investigation is being extended to health officials, politicans, doctors and journalists.

According to Polskaweb, big pharma has earned 40 billion dollars already from the swine flu scam.

snip

Danish journalists have also looked at the role of Dr. Frederick Hayden, an advisor of WHO and in charge of the special strategic group (LEGEND) which in July floated the plan of giving every person in the world two doses of the swine flu jab.

Hayden is allegedly on the payroll of Roche, RW Johnson, SmithKline Beecham and Glaxo Wellcome.

Other „experts“ who appear to be pushing junk science or even actively looking for virulent genes in the Swine Flu Gate, are John Oxford and Bruno Lina.

Both of these play leading roles in WHO and the EU.

con.

http://theflucase.com/index.php?option= ... 64&lang=en

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Post Re: WHO scandal - major funding by Big Pharma
Was the Threat of H1N1 Flu Exaggerated?
By Eben Harrell

By the summer of 2009, shortly after the H1N1 flu pandemic had first emerged, there was a waiting list for the first several million doses of the forthcoming new flu vaccine. At the head of the line, naturally, were the world's richest nations. "Again we see the advantage of affluence," said Margaret Chan, the head of the World Health Organization (WHO), at a news conference on July 14. "Again we see access denied by an inability to pay." Describing H1N1 as "entirely new and highly contagious," Chan scolded rich countries at the time for hoarding the "lion's share" of the global H1N1-vaccine supply.

Six months later, Chan's admonitions seem prescient. Rich countries' hoards have become massive surpluses, and many nations are now trying frantically to cancel pending orders of vaccines or transfer them to poorer nations. France, which had ordered enough of the vaccine to inoculate its entire population of 60 million, has so far used only 5 million doses and now wants to cancel 50 million doses and sell millions more. Similarly, the Netherlands has a 19 million–dose order for sale to other countries, while Germany is in talks with drug 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 of the vaccine they have received or have on order. The U.S., which has so far distributed 160 million of the 251 million doses it purchased to doctors, hospitals and other health care providers across the country, has yet to make a decision on whether it will have an overflow and what it will do with any surplus. (Watch TIME's video "Chicken Eggs and Antigens: How the H1N1 Vaccine Is Made.")

The excess in many countries occurred partly because health officials initially thought the vaccine would require two doses instead of one, and many countries signed contracts with manufacturers under that assumption; it turned out that a single dose was enough to build immunity. But the main reason for the surplus is simply that demand for the vaccine fell far short of what was originally expected. Now, after governments have spent billions of dollars on vaccines that were not needed — France alone spent $1.25 billion — some politicians and health professionals are looking to hold someone accountable.

"WHO advised us falsely. They raised a false alarm," says Dr. Wolfgang Wodarg, who served in Germany's parliament until September, faulting the U.N.'s global health agency for relying on an inadequate definition of a pandemic. (See what you need to know about the H1N1 vaccine.)

Wodarg notes that the agency declared the H1N1 pandemic based only on the new virus' transmissibility and did not take into consideration the severity of the strain. Wodarg blames the WHO for raising the alarm over a virus with little destructive potential, leading countries to embark on expensive mass-vaccination programs. He has organized a public parliamentary hearing on behalf of the Strasbourg-based human-rights group Council of Europe, titled "The Handling of the H1N1 Pandemic: More Transparency Needed?" The hearing, scheduled for Jan. 26, will explore the question of whether the WHO and governments overreacted to the threat of H1N1.

Keiji Fukuda, the WHO's special adviser on pandemic influenza, who will head a delegation to the Strasbourg hearing, counters that the WHO's definition of influenza pandemics has always been based on transmissibility and has never had anything to do with the lethality of a virus; it was no different with H1N1. In response to accusations of overreaction to what has amounted to a mild disease, Fukuda says that once the 2009 H1N1 pandemic had been declared, "WHO consistently made it clear that it could not predict the future course of the pandemic but consistently provided sober, balanced and scientifically supported information and guidance." (See how not to get H1N1 flu.)

Fukuda says also that claims that H1N1 is a mild pandemic are wrongheaded. "There have been over 14,000 deaths that have been laboratory-confirmed, many in young, previously healthy people. Who is going to tell their families that the virus is mild?" Fukuda wrote to TIME in an e-mail.

Indeed, it is not difficult to imagine an alternate scenario in which critics would now be accusing the agency of failing to warn countries properly of the H1N1 threat. Hugh Pennington, a microbiologist at the University of Aberdeen who has advised the British government on past public-health crises, says the WHO was obligated to raise the alarm as soon as H1N1's spread matched the medically accepted definition for a pandemic. He points out also that early news reports from Mexico and the U.S., where the virus first emerged, suggested a highly lethal disease. (See the top 10 medical breakthroughs of 2009.)

Still, Pennington says there are lessons to be learned. He says the vaccine surplus in many cases can be ascribed in part to countries' own pre-existing pandemic-preparedness plans. Many such plans, which were put in place in the mid-2000s, were based on the worst-case-scenario assumption that the next pandemic virus would be some variation of the highly lethal H5N1 bird-flu virus, which has so far killed 263 people. The U.K.'s plan, for example, which was automatically enacted when the WHO declared the H1N1 pandemic, predicted between 50,000 and 750,000 deaths from a flu pandemic. So far, there have been 400 British deaths from H1N1.

As part of their plans, many governments lined up multibillion-dollar advance-purchase agreements with pharmaceutical companies to buy vaccines during a pandemic. When the WHO declared H1N1 as such, governments were locked into these contracts, if not legally then politically — amid news reports of a new and potentially lethal virus spreading around the globe, governments could not responsibly pass on the option for vaccine. In this context, governments may have felt the only prudent course was to err on the side of caution.

Pennington says that to avoid similar situations of oversupply in the future, governments may want to plan a range of responses for the next flu pandemic, based on a virus' severity. But such evaluations of deadliness of an emerging disease are much harder to carry out than one would hope — if not impossible. And delaying action in response to an unpredictable new virus could potentially mean an increase in preventable deaths. "I think all countries recognize the desirability of flexibility in implementing pandemic plans. But exercising flexibility is really hard especially when large and complicated events like pandemics are often very confusing, and the expectations of populations can swing dramatically over short periods of time," says Fukuda.

The current glut of vaccines in rich nations may at least prove useful to the 95 countries in the developing world that have no access to vaccines, 86 of which have written to the WHO requesting help obtaining supplies. The WHO already has 200 million doses for such countries, and the first doses of that stockpile arrived in Mongolia and Azerbaijan this month. These doses will be supplemented by bilateral deals: France, for example, plans to sell 2 million vaccine doses at cost to Egypt and 300,000 to Qatar, according to a report in the Parisien newspaper. :roll

It appears that even in developing nations, however, the need for vaccines is not overwhelming. Despite fears that H1N1 would hit developing nations hardest, the pandemic is unfolding in those countries "in a similar pattern" to that in the developed world, says Fukuda — which is to say with relatively few deaths. In fact, some developing countries, particularly in West Africa, are reporting lower rates of infection than in the developed world. "Based on the current H1N1 strain, there are higher health priorities in the developing world," says Sandra Mounier-Jack of the Communicable Diseases Policy Group at the London School of Hygiene and Tropical Medicine, citing illnesses such as HIV, tuberculosis and malaria.

Mounier-Jack's comment echoes the basic question that Wodarg and other critics of the WHO are aiming to pose at Tuesday's hearing: Given that other health problems were more deserving of the billions of dollars spent tackling H1N1, how do the WHO and governments explain their decisions?

The U.S. government, for its part, still wants to vaccinate as many people as possible against H1N1. Although it has indeed been a mild flu season so far, says Jeff Dimond, a spokesperson at the Centers for Disease Control and Prevention, "our message right now is that people should get vaccinated. We are aware that a third wave of infections is possible, so we aren't making any decision yet on whether we will use our full capacity of 251 million doses."

http://www.time.com/time/health/article/0,8599,1956608,00.html?xid=rss-topstories

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http://www.bmj.com/cgi/content/full/340/jun03_4/c2912

WHO and the pandemic flu "conspiracies"
Deborah Cohen, features editor, BMJ, Philip Carter, journalist, The Bureau of Investigative Journalism, London

dcohen@bmj.com

Key scientists advising the World Health Organization on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the guidance they were preparing. These conflicts of interest have never been publicly disclosed by WHO, and WHO has dismissed inquiries into its handling of the A/H1N1 pandemic as "conspiracy theories." Deborah Cohen and Philip Carter investigate

Next week marks the first anniversary of the official declaration of the influenza A/H1N1 pandemic. On 11 June 2009 Dr Margaret Chan, the director general of the World Health Organization, announced to the world’s media: "I have conferred with leading influenza experts, virologists, and public health officials. In line with procedures set out in the International Health Regulations, I have sought guidance and advice from an Emergency Committee established for this purpose. On the basis of available evidence, and these expert assessments of the evidence, the scientific criteria for an influenza pandemic have been met...The world is now at the start of the 2009 influenza pandemic."

It was the culmination of 10 years of pandemic preparedness planning for WHO—years of committee meetings with experts flown in from around the world and reams of draft documents offering guidance to governments. But one year on, governments that took advice from WHO are unwinding their vaccine contracts, and billions of dollars’ worth of stockpiled oseltamivir (Tamiflu) and zanamivir (Relenza)—bought from health budgets already under tight constraints—lie unused in warehouses around the world. :gah

A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments. Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines? Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir? And why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO? We are left wondering whether major public health organisations are able to effectively manage the conflicts of interest that are inherent in medical science. :censor

Already WHO’s handling of the pandemic has led to an unprecedented number of reviews and inquiries by organisations including the Council of Europe, European Parliament, and WHO itself, following allegations of industry influence. Dr Chan has dismissed these as "conspiracies," and earlier this year, during a speech at the Centers for Disease Control and Prevention in Atlanta, she said: "WHO anticipated close scrutiny of its decisions, but we did not anticipate that we would be accused, by some European politicians, of having declared a fake pandemic on the advice of experts with ties to the pharmaceutical industry and something personal to gain from increased industry profits."

The inquiry by British MP Paul Flynn for the Council of Europe Parliamentary Assembly—due to be published today—will be critical. It will say that decision making around the A/H1N1 crisis has been lacking in transparency. "Some of the outcomes of the pandemic, as illustrated in this report, have been dramatic: distortion of priorities of public health services all over Europe, waste of huge sums of public money, provocation of unjustified fear amongst Europeans, creation of health risks through vaccines and medications which might not have been sufficiently tested before being authorised in fast-track procedures, are all examples of these outcomes. These results need to be critically examined by public health authorities at all levels with a view to rebuilding public confidence in their decisions."

The investigation by the BMJ/The Bureau reveals a system struggling to manage the inherent conflict between the pharmaceutical industry, WHO, and the global public health system, which all draw on the same pool of scientific experts. Our investigation has identified key scientists involved in WHO pandemic planning who had declarable interests, some of whom are or have been funded by pharmaceutical firms that stood to gain from the guidance they were drafting. Yet these interests have never been publicly disclosed by WHO and, despite repeated requests from the BMJ/The Bureau, WHO has failed to provide any details about whether such conflicts were declared by the relevant experts and what, if anything, was done about them.

It is this lack of transparency over conflicts of interests—coupled with a documented changing of the definition of a pandemic and unanswered questions over the evidence base for therapeutic interventions1—that has led to the emergence of these conspiracies.

WHO says: "Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and a profit-driven industry. Similar considerations apply when experts advising the Organization have professional links with pharmaceutical companies. Numerous safeguards are in place to manage possible conflicts of interest or their perception."

Another factor that has fuelled the conspiracy theories is the manner in which risk has been communicated. No one disputes the difficulty of communicating an uncertain situation or the concept of risk in a pandemic situation. But one world expert in risk communication, Gerd Gigerenzer, director of the Centre for Adaptive Behaviour and Cognition at the Max Planck Institute in Germany, told the BMJ/The Bureau: "The problem is not so much that communicating uncertainty is difficult, but that uncertainty was not communicated. There was no scientific basis for the WHO’s estimate of 2 billion for likely H1N1 cases, and we knew little about the benefits and harms of the vaccination. The WHO maintained this 2 billion estimate even after the winter season in Australia and New Zealand showed that only about one to two out of 1000 people were infected. Last but not least, it changed the very definition of a pandemic."

WHO for years had defined pandemics as outbreaks causing "enormous numbers of deaths and illness" but in early May 2009 it removed this phrase—describing a measure of severity—from the definition.2

The beginnings
The routes to the Council of Europe’s criticisms can be traced back to 1999, a pivotal year in the influenza world. In April that year WHO—spurred on by the 1997 chicken flu outbreak in Hong Kong—began to organise itself for a feared pandemic. It drew up a key document, Influenza Pandemic Plan: The Role of WHO and Guidelines for National and Regional Planning.

WHO’s first influenza pandemic preparedness plan was stark in the scale of the risk the world faced in 1999: "It is impossible to anticipate when a pandemic might occur. Should a true influenza pandemic virus again appear that behaved as in 1918, even taking into account the advances in medicine since then, unparalleled tolls of illness and death would be expected."

In the small print of that document it states: "R Snacken, J Wood, L R Haaheim, A P Kendal, G J Ligthart, and D Lavanchy prepared this document for the World Health Organization (WHO), in collaboration with the European Scientific Working Group on Influenza (ESWI)." What this document does not disclose is that ESWI is funded entirely by Roche and other influenza drug manufacturers. Nor does it disclose that René Snacken and Daniel Lavanchy were participating in Roche sponsored events the previous year, according to marketing material seen by the BMJ/The Bureau.

Dr Snacken was working for the Belgian ministry of public health when he wrote about studies involving neuraminidase inhibitors for a Roche promotional booklet. And Dr Lavanchy, meanwhile, was a WHO employee when he appeared at a Roche sponsored symposium in 1998. His role at that time was in the WHO Division of Viral Diseases. Dr Lavanchy has declined to comment.

In 1999 other members of the European Scientific Working Group on Influenza included Professor Karl Nicholson of Leicester University, UK, and Professor Abe Osterhaus of Erasmus University in the Netherlands. These two scientists are also identified in Roche marketing material seen by this investigation which was produced between 1998 and 2000. Professor Osterhaus told the BMJ that he had always been transparent about any work he has done with industry. Professor Nicholson similarly has consistently declared his connections with pharmaceutical companies, for example, in papers published in journals such as the BMJ and Lancet.

Both experts were also at that time engaged in a randomised controlled trial on oseltamivir supported by Roche. The trial was subsequently published in the Lancet in 2000.3 It remains one of the main studies supporting oseltamivir’s effectiveness—and one that was subsequently shown to have employed undeclared industry funded ghostwriters.1 :censor :rant :flame

The influence of the European Scientific Working Group on Influenza would continue as the decade wore on and the calls for pandemic planning became more strident. Founded in 1992, this "multidisciplinary group of key opinion leaders in influenza aims to combat the impact of epidemic and pandemic influenza" and claims links to WHO, the Robert Koch Institute, and the European Centre for Disease Prevention and Control, among others.4 Despite the group’s claims of scientific independence its 100% industry funding does present a potential conflict of interest. One if its roles is to lobby politicians, as highlighted in a 2009 policy document.5

At a pre-pandemic preparation workshop of the European Scientific Working Group on Influenza in January last year, Professor Osterhaus said: "I can tell you that ESWI is working on that idea [that is, convincing politicians] quite intensively. We have contact with MEPs [members of the European Parliament] and with national politicians. But it is they who have to decide at the end of the day, and they will only act at the request of their constituencies. If the latter are not prompted, nothing will happen."

The group’s policy plan for 2006-10 specifically stated that government representatives needed to "take measures to encourage the pharmaceutical industry to plan its vaccine/antivirals production capacity in advance" and also to "encourage and support research and development of pandemic vaccine" and to "develop a policy for antiviral stockpiling." It also added that government representatives needed to know that "influenza vaccination and use of antivirals is beneficial and safe." It said that the group provided "evidence based, palatable information"; and also "networking/exchange with other stakeholders (eg, with industry in order to establish pandemic vaccine and antivirals contracts)." In the meantime, in Roche’s own marketing plan, one goal was to "align Roche with credible third party advocates". They "leveraged these relationships by enlisting our third-party partners to serve as spokespeople and increase awareness of Tamiflu and its benefits."6

Barbara Mintzes, assistant professor in the Department of Pharmacology and Therapeutics at the University of British Columbia, is currently part of a group working with Health Action International and WHO developing model curricula for medical and pharmaceutical students on drug promotion and interactions with the industry, including conflicts of interest. She thinks that caution is advised when working with medical bodies of this sort.

"It is legitimate for WHO to work with industry at times. But I would have concerns about involvement with a group that looks like it is for independent academics that is actually mainly industry funded," she told the BMJ/The Bureau, adding: "The Institute of Medicine has raised concerns about the need to have a firewall with medical groups. To me this does not sound like an independent group, as it is mainly funded by manufacturers."

She also thinks that there is a difference between the conflict of interest in having a clinical trial funded by a company and the conflict of interest in being involved in marketing a drug—for example, on a paid speaker’s bureau or in marketing material. "Some academic medical departments, for example Stanford University, have banned staff from being involved in marketing or being on a paid speakers bureau," she said. ;)

The presence of leading influenza scientists at promotional events for oseltamivir reflected not just the concern of an impending pandemic, but the excitement over the potential of a new class of drugs—neuraminidase inhibitors—to offer treatment and protection against seasonal influenza.

In 1999 two new drugs first came to market: oseltamivir, from Roche; and zanamivir, manufactured by what is now GlaxoSmithKline. The two drugs would battle it out over the coming years, with oseltamivir—aided by its oral administration—trumping its rival in global sales as the decade wore on.

The potential was quickly grasped. Indeed, that year Professor Osterhaus published an article proposing the use of neuraminidase inhibitors in pandemics: "Finally, during a possible future influenza pandemic, in view of their broad reactivity against influenza virus neuraminidase subtypes and the expected lack of sufficient quantities of vaccine, the new antivirals will undoubtedly have an essential role to play in reducing the number of victims."7

However, he also warned that antivirals should not be seen as a replacement for vaccinations. "Close collaboration and consultation between, on the one hand, companies marketing influenza vaccines and, on the other, those marketing antivirals will therefore be absolutely essential. It is important that a clear and uniform message indicating the complementary roles of vaccines and antivirals is delivered."

That article appeared in the European Scientific Working Group on Influenza’s bulletin of April 1999; Professor Osterhaus signs off with the affiliation of WHO National Influenza Centre Rotterdam, The Netherlands.

Other experts soon followed suit—recommending the role neuraminidase inhibitors could play in any future pandemic—in both the academic literature and in the general media.

Food and Drug Administration
While the excitement over these drugs fuelled scientific symposiums, the US Food and Drug Administration (FDA) was less than convinced. The BMJ/The Bureau has since spoken to people from within the American and European drug regulators, the FDA and the European Medicines Agency (EMEA), who said that both regulators struggled with the paucity of the data presented to them for zanamivir and oseltamivir, respectively, during the licensing process. At the end of last year, the BMJ called for access to raw data for key public health drugs after the Cochrane Collaboration found the effectiveness of the drugs impossible to evaluate.8 The group are continuing to negotiate access to what they say they need to fully assess the effectiveness of antivirals.

In the US, the FDA first approved zanamivir in 1999.9 Michael Elashoff, a former employee of the FDA, was the statistician working on the zanamivir account. He told the BMJ how the FDA advisory committee initially rejected zanamivir because the drug lacked efficacy. :shock:

After Dr Elashoff’s review (he had access to individual patient data and summary study reports) the FDA’s advisory committee voted by 13 to 4 not to approve zanamivir on the grounds that it was no more effective than placebo when the patients were on other drugs such as paracetamol. He said that it didn’t reduce symptoms even by a day.

"When I was reviewing the data, I tried to replicate the analyses in their summary study reports. The issue was not of data quality, but sensitivity analyses showed even less efficacy," he said. "The safety analysis showed there were safety concerns, but the focus was on if Glaxo had demonstrated efficacy." Dr Elashoff’s view was that zanamivir was no better than placebo—and it had side effects. And when the FDA medical reviewer made a presentation, her conclusion was that it could either be approved or not approved. It was a fairly borderline drug.

There were influenza experts on the FDA’s advisory committee and much of the discussion hinged on why a drug that looked so promising in earlier studies wasn’t working in the largest trials in the US. One hypothesis was that people in the US were taking other drugs for symptomatic relief that masked any effect of zanamivir. So zanamivir might have no impact on symptoms over and above the baseline medications that people take when they have influenza. :censor :rant

Two other trials—one in Europe and one in Australia— showed a bit more promise. But there was a very low rate of people taking other medications. "So in the context of not being allowed to take anything for symptomatic relief, there might be some effect of Relenza. But in the context of a typical flu, where you have to take other things to manage your symptoms, you wouldn’t notice any effect of Relenza over and above those other things," Dr Elashoff said. The advisory committee recommended that the drug should not be approved.

Nevertheless, FDA management decided to overturn the committee’s recommendation.

"They would feel better if there was something on the market in case of a pandemic. It wasn’t a scientific decision," Dr Elashoff said. :roll :doh

While Dr Elashoff was working on the zanamivir review, he was assigned the oseltamivir application. But when the review and the advisory committee decided not to recommend zanamivir, the FDA’s management reassigned the oseltamivir review to someone else. Dr Elashoff believes that the approval of zanamivir paved the way for oseltamivir, which was approved by the FDA later that year.

European Medicines Agency
In Europe the EMEA was similarly troubled by the evidence for oseltamivir. By early 2002 Roche had sought a European Union-wide licence from the EMEA. It was a lengthy process, taking three meetings of the Committee for Medicinal Products for Human Use as well as expert panels, according to one of the two rapporteurs, Pekka Kurki of the Finnish Medicines Agency. Echoing the Cochrane Collaborations’s 2009 findings6 Kurki told us: "We discussed the same issues that are still discussed today: does it show clinically significant benefits in treatment and prophylaxis of flu and what was the magnitude of the benefits presented in the RCTs? Our assessment and Cochrane’s in 2009 are very similar with regard to the effect size in RCTs. The data show that the effects of Tamiflu were clear but not very impressive.

"What was unclear and is still unclear is what is the impact of Tamiflu on serious complications. Circulating influenza was very mild when Tamiflu was developed and therefore it is very difficult to say anything about serious complications. The data did not clearly show an effect on serious complications—it was not demonstrated by the RCTs."

In documents obtained under the freedom of information legislation, two of the experts who provided opinions during the EMEA licensing process have also featured in Roche marketing material: Annike Linde and Rene Snacken. In Dr Snacken’s EMEA presentation dated 18 February 2002, he discussed the need for chemoprophylaxis and called for the use of oseltamivir during a pandemic. He made his presentation as a representative of the Belgian Ministry of Public Health. At the time Dr Snacken was also "liaison officer" for the European Scientific Working Group on Influenza. He also played a key role in the Belgian government during its pandemic planning, and he later became a senior expert at the Preparedness and Response Unit, European Centre for Disease Prevention and Control. We do not know what, if anything, he declared to the EMEA about his relationship with Roche.

Annike Linde has confirmed in an email that she has had connections with Roche over a number of years. She made a presentation to the EMEA on "influenza surveillance" in her capacity as a representative of the Swedish Institute for Infectious Disease. Again, it is not clear what, if anything, she declared to the EMEA concerning her previous relationship with Roche.

Dr Linde, now the Swedish state epidemiologist, has told the BMJ/The Bureau that she received payments from Roche International in respect of various pieces of work she did for the company until 2002. She has subsequently given occasional lectures for Roche Sweden. All money she has received from Roche was given, Dr Linde says, to the Swedish Institute for Infectious Disease Control.

We asked the scientists whether they declared their relationship with Roche at the time to the EMEA. Neither has answered that question entirely satisfactorily. Dr Snacken has not replied to repeated emails posing this question. Dr Linde responded by telling the BMJ/The Bureau: "We contribute with our expertise to the regulatory agencies when asked. When we do so, a declaration of interest, where e.g. participation at advisory meetings at Roche, is given and evaluated by the regulatory agency." The BMJ/The Bureau requested Linde and Snacken’s declaration of interest statements for the 2002 meeting from the EMEA under the freedom of information act. The EMEA was unable to provide statements for those particular people at that time.


Developing the guidelines
In October 2002 WHO convened a meeting of influenza experts at its Geneva headquarters. Their purpose was to develop WHO’s guidelines for the use of vaccines and antivirals during an influenza pandemic.

Included at this meeting were representatives from Roche and Aventis Pasteur and three experts who had lent their name to oseltamivir’s marketing material (Professors Karl Nicholson, Ab Osterhaus, and Fred Hayden).

Two years later the WHO published a key report from that meeting, WHO Guidelines on the Use of Vaccines and Antivirals during Influenza Pandemics 2004. The specific guidance on antivirals, Considerations for the Use of Antivirals During an Influenza Pandemic, was written by Fred Hayden. Professor Hayden has confirmed to the BMJ/The Bureau in an email that he was being paid by Roche for lectures and consultancy work for the company at the time the guidance was produced and published. He also told us in an email that he had received payments from GlaxoSmithKline for consultancy and lecturing until 2002. According to Prof Hayden: "DOI [declaration of interest] forms were filled out for the 2002 consultation."

The WHO guidance concluded that: "Based on their pandemic response goals and resources, countries should consider developing plans for ensuring the availability of antivirals. Countries that are considering the use of antivirals as part of their pandemic response will need to stockpile in advance, given that current supplies are very limited." Many countries around the world would adopt this guidance.

The previous year Professor Hayden was also one of the main authors of a Roche sponsored study that claimed what was to become one of oseltamivir’s main selling points—a claimed 60% reduction in hospitalisations from flu, which the Cochrane Collaboration was later unable to verify.8

Our investigation has also identified relevant and declarable interests relating to the two other named authors of annexes to WHO’s 2004 guidelines. Arnold Monto was the author of the annexe dealing with vaccine usage in pandemics. Between 2000 and 2004—and at the time of writing the annexe—Dr Monto has consistently and openly declared honorariums, consultancy fees, and research support from Roche, 10 11 12 consultancy fees and research support from GlaxoSmithKline 10 12 13 14; and also research funding from ViroPharma.15

No conflict of interest statement was included in the annex he wrote for WHO. When asked if he had signed a declaration of interest form for WHO, Dr Monto told the BMJ/The Bureau: "Conflict of Interest forms are requested before participation in any WHO meeting".

Professor Karl Nicholson is the author of the third annex, Pandemic Influenza. According to declarations made by Professor Nicholson in the BMJ16and Lancet in 2003,17 he had received travel sponsorship and honorariums from GlaxoSmithKline and Roche for consultancy work and speaking at international respiratory and infectious diseases symposiums. Before writing the annexe, he had also been paid and declared ad hoc consultancy fees by Wyeth, Chiron, and Berna Biotech.

Even though the previous year these declarations had been openly made in the Lancet and the BMJ, no conflict of interest statement was included in the annex he wrote for WHO. Professor Nicholson told the BMJ/The Bureau that he last had "financial relations" with Roche in 2001. When asked if he had signed a declaration of interest form for WHO, Prof Nicholson replied: "The WHO does require attendees of meetings, such as those held in 2002 and 2004, to complete declarations of interest."

Leaving aside the question of what declarations experts made to WHO, one simple fact remains: WHO itself did not publicly disclose any of these conflicts of interest when it published the 2004 guidance. It is not known whether information about these conflicts of interest was relayed privately to governments around the world when they were considering the advice contained in the guidelines.

The year before WHO issued the 2004 guidance, it published a set of rules on how WHO guidelines should be developed and how any conflicts of interest should be handled. This guidance included recommendations that people who had a conflict of interest should not take part in the discussion or the piece of work affected by that interest or, in certain circumstances, that the person with the conflict should not participate in the relevant discussion or work at all. The WHO rules make provision for the director general’s office to allow declarations of interest to be seen if the objectivity of a meeting has been called into question.18

The BMJ/The Bureau has asked WHO for the conflict of interest declarations for the Geneva 2002 meeting and those related to the guidance document itself. WHO told us that the query went directly up to Margaret Chan’s office. "WHO never publishes individual DOIs [declaration of interest], except after consultation with the Office of the Director-General. In this case, we put in a request on your behalf but it was not granted. In more recent years, many WHO committees have published summaries of relevant interests with their meeting reports."

In a BMJ interview (see film on bmj.com), WHO spokesperson Gregory Hartl reiterated the fact that Dr Margaret Chan, "is very committed personally to transparency." Yet her office has turned down repeated requests for declaration of interest statements and declines to comment on the allegations that authors of the guidelines had declarable interests.

Nevertheless, Prof Hayden told the BMJ/The Bureau: "I strongly support transparency in declarations of interest, in part because this allows those reading documents, particularly ones authored by specific individuals (eg, Annex 5) [the part he wrote], to make their own judgments about the possible relevance of any potential conflicts."

While experts need to work with industry to develop the best possible drugs for illnesses, questions remain about what level of involvement experts with industry ties should have in the formulation of public health policy decisions and guidelines. Professor Nicholson told the BMJ/The Bureau: "The WHO and decision makers must be informed of ongoing developments and research findings to ensure that they are as up to date as possible. Some of the most relevant expertise and information are held by companies or individuals with conflicts of interest. I understand the view that experts with conflicts of interest should not advise governments or organisations such as the WHO. But to exclude such people from discussions could deprive WHO and decision makers of important new information."

But not everyone agrees. Barbara Mintzes is unequivocal about what role they should play. "No one should be on a committee developing guidelines if they have links to companies that either produce a product—vaccine or drug—or a medical device or test for a disease. It would be preferable that there are no financial ties when it comes to making big decisions on public health—for example, stockpiling a drug—and that includes if they have a currently funded clinical trial," she said.

"Ideally, what you want are independent experts who are in the public sector to provide expertise on drugs and vaccines. But they can be hard to find. One solution is consult with the experts who are involved in industry, but not put them on any decision making committee. You need a firewall," she added.

Indeed, Professor Harvey Fineberg, president of the Institute of Medicine and chairman of the panel reviewing WHO’s management of the pandemic, takes a similarly hard line. His own institution went through a detailed review of how they interact with industry and experts with conflicts of interests last year.19 "Sometimes publication of conflict of interests is enough—for example with a journal. But if you are giving expert judgment to influence policy, revealing is not enough," he told the BMJ, referring to the Institute of Medicine’s policy.

WHO also says that it takes conflicts of interests seriously and has the mechanisms in place to deal with them. But what action does it take when a scientist declares a conflict of interest, and when does it judge a scientist to be too conflicted to play a leading role in the formulation of global health policy? Since WHO has not provided us with an answer to this question, we are left to guess.

As it stands, this situation is the worst possible outcome for WHO, according to Professor Chris Del Mar, a Cochrane Review author and expert on WHO’s Strategic Advisory Group of Experts on Immunization group. "If it proves to be the case that authors of WHO guidance which promoted the use of certain drugs were being paid at the same time by the makers of those drugs for other work they were doing for these companies that is reprehensible and should be condemned in the strongest possible terms."

WHO’s endorsement of oseltamivir was not lost on Roche. In an advert placed by the company for the drug in the main conference programme of the European Scientific Working Group on Influenza’s 2005 conference in Malta, it says: "Antivirals will initially be the principal medical intervention in a pandemic situation and Roche is working as a responsible partner with governments to assist in their pandemic planning." The source reference for this is the WHO Global Influenza Preparedness Plan.

Throughout the following years, WHO would appear to have been inconsistent in how it treated conflicts of interest. Updated pandemic plans would continue to be prepared by experts who openly had work funded and acted as consultants to manufacturers of vaccines and antivirals. WHO produced its global influenza preparedness plan in 2005, and in 2006 it constituted an interim Influenza Pandemic Task Force. No public declarations of interest have been made and to date no details have been provided by WHO in response to our requests.

WHO’s stance that it does not publish declarations of interest from its experts is far from consistent. It is undermined, for example, by the position WHO adopts in relation to the Strategic Advisory Group of Experts on Immunization, its standing vaccine advisory body. Here, contrary to its approach to pandemic planning advisers, WHO does publish summaries of declarations of interest.


Emergency Committee
These seeming inconsistencies in WHO’s approach to transparency and its handling of conflicts of interest extend into the workings of the Emergency Committee formed last year to advise the director general on the pandemic. The identities of its 16 members are unknown outside WHO. This secret committee has guided WHO pandemic policy since then—including deciding when to judge that the pandemic is over.

WHO says it has to keep the identities secret to protect the scientists from being influenced or targeted by industry. In a phone call to the BMJ/The Bureau in March, WHO spokesperson Gregory Hartl explained: "Our general principle is we want to protect the committee from outside influences."

The committee advised the WHO director general on phase changes as well as temporary recommendations. According to WHO, When the Emergency Committee met to discuss a possible move to a declaration of a pandemic, the meeting additionally included members who represented Australia, Canada, Chile, Japan, Mexico, Spain, the UK, and the US, eight countries that experienced widespread outbreaks at the time. These national representatives were present to ensure full consideration of the views and possible reservations of the countries expected to bear the initial brunt of economic and social repercussions.

WHO says all members of the Emergency Committee sign a confidentiality agreement, provide a declaration of interests, and agree to give their consultative time freely, without compensation. However, only one member of the committee has been publicly named: Professor John MacKenzie, who chairs it.

This is a troubling stance: it suggests that WHO considers other advisory groups whose members are not anonymous —such as the Strategic Advisory Group of Experts on Immunization—to be potentially subject to outside influences, and it allows no scrutiny of the scientists selected to advise WHO and global governments on a major public health emergency.

Under the International Health Regulations framework, the membership of the Emergency Committee is drawn from a roster of about 160 experts covering a range of public health areas. This framework provides guidelines about how WHO deals with acute public health risks. The BMJ/The Bureau has identified approximately 15 scientists from the International Health Regulations roster with influenza expertise and has emailed them to ask if they were on the Emergency Committee. Under the framework at least some of these scientists are members of the Emergency Committee. Yet because of the confidentiality agreements they have signed, these scientists cannot acknowledge their membership of the committee, putting them in an invidious position.

David Salisbury, chair of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) committee at the time of the pandemic and a member of the International Health Regulations, says the secrecy has caused problems for his group. "It certainly caused problems for SAGE. Since all of the details of SAGE are in the public domain, there was a perception that it had been SAGE that had given advice about the changing of definitions or the pandemic levels—when we had not done so. SAGE members came in for unfair personal abuse by journalists," he told the BMJ/The Bureau.

"Given the importance of the advice, the transparency of the source of the advice was important. I believe it is necessary to keep confidential the source of advice if revealing details might put individuals at risk, for example when bioterrorism is being discussed. This does not seem to be the case for pandemic flu," he added.

The secrecy of the committee is also fuelling conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. A key question will be whether the pharmaceutical companies, which had invested around $4bn (£2.8bn, 3.3bn) in developing the swine flu vaccine, had supporters inside the emergency committee, who then put pressure on WHO to declare a pandemic. It was the declaring of the pandemic that triggered the contracts.

The BMJ/The Bureau can confirm that Dr Monto, Dr John Wood, and Dr Masato Tashiro are members of the Emergency Committee.

Although Dr Monto did not answer the question directly, his Infectious Disease Society of America biography states that he is a member.20

Last year, according to figures made public in the US by GlaxoSmithKline, Professor Monto received $3000 speakers fees from the company in the period between the second quarter and the last quarter of 2009. As a national official of the Japanese government, Dr Tashiro says that he must "have nothing concerning conflict of interest with private companies". Dr John Wood works for the UK National Institute for Biological Standards and Control (NIBSC). Dr Wood, like Dr Tashiro, has no personal conflict of interests but he told the BMJ/The Bureau that as part of its statutory role in developing standards for measurement of biological medicines to ensure accurate dosing and carrying out independent control testing to assure their safety and efficacy, the institute must work closely with the pharmaceutical industry. This is made clear on their website.

"The International Federation of Pharmaceutical Manufacturers and Associations has also made publicly available the nature of their close interaction with NIBSC and similar organisations in order to develop influenza vaccines," he said.21

Those who said that they were not on the committee include David Salisbury, Alan Hampson, Albert Osterhaus, Donato Greco, and Howard Njoo. Maria Zambon, from the UK’s Health Protection Agency told the BMJ: "I undertake various advisory roles to WHO. Declaration of interest statements are prepared before undertaking such roles.

"The HPA Centre for Infection, as part of its role in national infectious disease surveillance, provision of specialist and reference microbiology and vaccine efficacy monitoring, works closely with vaccine manufacturers and biotechnology companies."


International Health Regulations review
WHO’s own review into the operation of the International Health Regulations and WHO’s handling of the pandemic is now being conducted by Harvey Feinberg, president of the US Institute of Medicine, and will report its findings next year. Dr Chan and Professor Feinberg have both made clear the need for a thorough investigation. But questions are already arising about how independent the review will turn out to be. According to the International Health Regulations list in our possession, some 13 of the 29 members of the review panel are members of the International Health Regulations itself and one is the chair of the Emergency Committee. To critics that might suggest a somewhat incestuous approach.

Professor Mintzes does not agree with WHO’s explanation that secrecy was needed to protect against the influence of outside interest on decision making. "I can’t understand why the WHO kept this secret. It should be public in terms of accountability like the expert advisory committees. If the rationale of secret membership is not to be unduly influenced, there are other ways of dealing with this through strong conflict of interest provisions," she said.

She also believes that the very nature of allowing a trigger point for vaccine contracts opens the system up unnecessarily to exploitation. "It seems a problem that this declaration might trigger contracts to be realised. There should be safeguards in place to make sure those with an interest in vaccine manufacturers can’t exploit the situation. The WHO will have to look long and hard at this in future," she said.

The number of victims of H1N1 fell far short of even the more conservative predictions by the WHO. It could, of course, have been far worse.. Planning for the worst while hoping for the best remains a sensible approach. But our investigation has revealed damaging issues. If these are not addressed, H1N1 may yet claim its biggest victim—the credibility of the WHO and the trust in the global public health system. :censor

Cite this as: BMJ 2010;340:c2912




--------------------------------------------------------------------------------
Competing interests: PC declares no competing interests. DC has been paid expenses by WHO for giving talks at two conferences.

_________________
The test of our progress is not whether we add more to the abundance of those who have much; it is whether we provide enough for those who have too little. - FDR


Mon Jun 07, 2010 12:03 pm
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