World Health Organization Scientists Linked to Swine Flu Vaccine Makers
Investigation Raises Questions About WHO's Handling of H1N1 Pandemic
By TODD NEALE, MedPage Today
—June 5, 2010
Scientists who advised the World Health Organization on its influenza policies and recommendations including the decision to proclaim the so-called swine flu a "pandemic" had close ties to companies that manufacture vaccines and antiviral medicines like Tamiflu, a fact that WHO did not publicly disclose.
The links between the advisors and the companies that make money from vaccines and flu treatments were detailed in a report published online by the British medical journal BMJ, which investigated the advisors' role in WHO's policy.
The report by Deborah Cohen, features editor of BMJ, and Philip Carter, a journalist with the Bureau of Investigative Journalism in London, acknowledged that flu experts do "need to work with industry to develop the best possible drugs for illnesses," but said that allowing industry experts to have a role in the formulation of public health policy was a slippery slope.
And worse, Cohen and Carter said, was the failure of WHO officials to disclose the conflicts of interest or even identify the members of its advisory committee.
In a statement, WHO's secretary-general Margaret Chan, MD, MPH, said the purpose of keeping the committee members anonymous "is to protect the integrity and independence of the members while doing this critical work but also to ensure transparency by publicly providing the names of the members as well as information about any interest declared by them at the appropriate time."
And in the U.S. a spokesperson for the Department of Health and Human Services defended WHO's handling of the pandemic.
"The WHO handled the outbreak in a very measured and appropriate manner," he said. "Their decisions were driven by the existing and evolving conditions at the time and what the best scientific information was telling us. It's very easy to look back through a 20-20 lens and essentially be an armchair quarterback."
Addressing the possibility of industry-influence on WHO's decisions, the spokesman said, "The WHO based its decisions on strong public health considerations and I don't think there was any indication from our perspective that their decisions were influenced by industry in any way."
The H1N1 pandemic, which will mark its one-year anniversary on June 11, "could, of course, have been far worse," Cohen and Carter wrote. "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."
And the medical journal wasn't the only entity going on record with a critical assessment of WHO. A report from the Council of Europe Parliamentary Assembly published on the same day the BMJ report was released called into question WHO's handling of the H1N1 pandemic.
An official Council of Europe inquiry led by Paul Flynn, a British member of parliament, concluded that the "Parliamentary Assembly is alarmed about the way in which the H1N1 influenza pandemic has been handled, not only by the World Health Organization (WHO), but also by the competent health authorities at the level of the European Union and at national level."
World Health Organization and H1N1 Flu
Flynn's team stopped short of saying that WHO had bungled the pandemic, but did conclude that some of WHO's actions led to the "waste of large sums of public money, and also unjustified scares and fears about health risks faced by the European public at large."
Infectious disease specialists contacted by ABC News/MedPage Today agreed that the lack of disclosure was troubling, but there was little criticism of the WHO's decision declare the worldwide H1N1 outbreak a pandemic, nor were there many knocks about WHO's handling of the pandemic.
"I do find these investigations troubling, when the only way WHO could be exonerated is if there had been tens of millions dead," said John Barry, a distinguished scholar at Tulane University and author of The Great Influenza. "And then we'd have investigations about how ineffective they were."
"While I agree WHO should have disclosed any relationship between advisors and industry," he continued, "based on what WHO actually did, I find it absurd to accuse them of having been influenced by the drug industry. Antivirals, though hardly a magic bullet, are the only drug option. And a recommendation to stockpile them was the only option."
John Bartlett, MD, founding director of the Center for Civilian Biodefense Strategies at Johns Hopkins, echoed those sentiments. That conflicts of interest are prevalent among influenza experts "is not at all surprising to me since the people in medicine who know most about flu are often conflicted because they also are advisors to pharma and often do the big trials that are funded by pharma."
Bartlett said he was not an authority on influenza, but added, "The colleagues I know who do this work often/usually have these connections, but that is usually good for better pharma and good for better WHO advice."
Addressing concerns that the pandemic was declared to profit pharmaceutical companies, Barry said that "if anything WHO was slow to make that call. And if you know anything about the history of the influenza virus, again it had no option. 1918 saw a very mild spring wave, quite comparable to what we experienced in 2009. It turned virulent months later."
"This is a classic case of 20-20 hindsight, with some witch hunting thrown in," Barry said.
Dr. John Treanor, a vaccine expert at the University of Rochester Medical Center, in Rochester, N.Y., agreed that WHO's preparations were justified.
"I think even the authors [of the BMJ report] would have to agree that there really was no choice here but to prepare for a pandemic," he said. "If there had been a severe pandemic and there had been no preparations, the outcome (and the outcry) would have been far worse."
World Health Organization and H1N1 Flu Although some of the WHO's advisors received compensation from manufacturers of the same antivirals and vaccines recommended for use during the H1N1 pandemic, Treanor noted that there are few options available for combating influenza.
"You can tweak the plans how much antivirals, what kinds, where is the vaccine coming from, who should be vaccinated first, should you close schools, etc. but the basic elements are going to be the same," he said. "So I don't see the argument here as whether WHO made the right recommendation at the time, regardless of who was advising them they clearly did."
Arthur Reingold, MD, head of the division of epidemiology at the University of California Berkeley School of Public Health and head of the California Emerging Infections Program, said, "WHO would have received identical advice [regarding] the need to stockpile antiviral drugs and speed the development of vaccines from any competent expert in the field without industry ties."
But not all researchers were willing to give WHO a free pass on its handling of H1N1. Henry Miller, MD, a biotechnology expert at Stanford University's Hoover Institution, said WHO made a number of mistakes, and its declaration of a pandemic was one of them.
That said, Miller added, "the stockpiling of anti-flu medicines and the production of vaccine weren't among [WHO's mistakes]."
Cohen and Carter detailed WHO's pandemic influenza preparation starting in 1999, when a preparedness plan was drafted by six researchers in collaboration with the European Scientific Working Group on Influenza (ESWI). Over the next decade, according to their investigation, WHO failed to disclose industry ties among researchers advising the organization.
The document drafted in 1999 did not include information on conflicts of interest. Cohen and Carter pointed out that ESWI is funded entirely by Roche, which makes Tamiflu (oseltamivir) and that two of the authors of the document had participated in Roche-sponsored events in the previous year. Both were also involved in a randomized controlled trial of Tamiflu supported by the company.
In 2002, WHO called together flu experts to craft guidelines for the use of vaccines and antivirals during an influenza pandemic. The panel included representatives of Roche and Aventis Pasteur (now Sanofi-Pasteur), which makes flu vaccine, and three experts who had been named in marketing material for Tamiflu.
The resulting report, which advised stockpiling antivirals, was published in 2004, and the main author, Frederick Hayden, MD, of the University of Virginia in Charlottesville, confirmed that Roche was paying him for lectures and consulting when the report was produced and published.
Several additions to the report did not include information about conflicts of interest, according to Cohen and Carter.
"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," they wrote.
Compounding this lack of transparency is the fact that the 16 members of the emergency committee that has been advising WHO during the H1N1 pandemic have remained anonymous, at least officially. The chair is known to be John MacKenzie of Curtin University in Perth, Australia.
The BMJ investigation turned up another three members, including Arnold Monto, M.D., of the University of Michigan School of Public Health; John Wood, Ph.D., of the National Institute for Biological Standards and Control in the U.K.; and Masato Tashiro, M.D., Ph.D., director of the WHO collaborating center for surveillance and research on influenza in Tokyo.
Wood and Tashiro said they have no conflicts of interest, but Monto has received speaker's fees from GlaxoSmithKline, maker of another antiviral, Relenza (zanamivir).
According to the University of Rochester's Treanor, the important issue to consider is not whether WHO made the right decisions about the H1N1 pandemic because he believes they made the right recommendations at the time but "the much more tricky and generic question about how to appropriately separate the interests of the pharmaceutical industry from the interests of public health, while at the same time being able to take advantage of existing expertise on the issues, the bulk of which resides in individuals with some kind of ties to industry."
"In our current system of healthcare," Treanor said, "the responsibility for demonstrating that these interventions are safe and effective lies with the manufacturer. Hence, individuals with the greatest experience and insight into these interventions will almost always either be employees of industry or individuals paid by industry to conduct studies."
However, according to Philip Alcabes, associate professor of epidemiology at City University of New York Hunter College, investigations should go far beyond the question of whether potential links to drug companies went unpublicized.
"Even when nobody is directly in the pay of a corporation, policy decisions are too-often made by members of the Big Public Health party," said Alcabes. "H1N1 flu was a great example." When evaluating advice from a panel of experts, Treanor said it's important to consider the fact that researcher's will always view the products they do work on in a positive light, even if they weren't paid by industry.
"After all," Treanor said, "it's much more fun to be involved in the development of an effective product than one that doesn't work."
Finally, Dr. Donald A. Henderson, who served for three years as Director of the Office of Public Health Emergency Preparedness in the Bush administration and who is perhaps best known for his role in leading the effort to eradicate smallpox, brings the perspective of long experience to analysis of WHO's handling of H1N1.
Henderson, who is now a professor of medicine and public health at the University of Pittsburgh, agreed that too much antivirals were stockpiled and too many vaccines produced, and when that happens the body politic demands "someone or some organization must be blamed -- in this case, WHO has been named, and its policy of using experts who may not have disclosed possible relationships with relevant pharmaceutical companies. However, WHO is not an authoritarian and all-knowledgeable body as witness the fact that a number of different countries (e.g. USA, U.K., Sweden, Canada and a number of others) convened their own expert committees and reached different conclusions as to how much vaccine and antiviral products they would buy and policies for their use.
"So, why is WHO singled out? Each national body and expert group is more comfortable ascribing mistakes in strategy or policy to someone else. WHO is a handy whipping post. I would characterize this focus on WHO as a 'cheap shot.'"
Reports accuse WHO of exaggerating H1N1 threat, possible ties to drug makers
By Rob Stein
Washington Post Staff Writer
Friday, June 4, 2010; 3:52 PM
European criticism of the World Health Organization's handling of the H1N1 pandemic intensified Friday with the release of two reports that accused the agency of exaggerating the threat posed by the virus and failing to disclose possible influence by the pharmaceutical industry on its recommendations for how countries should respond.
The WHO's response caused widespread, unnecessary fear and prompted countries around the world to waste millions of dollars, according to one report. At the same time, the Geneva-based arm of the United Nations relied on advice from experts with ties to drug makers in developing the guidelines it used to encourage countries to stockpile millions of doses of antiviral medications, according to the second report.
The reports outlined the drumbeat of criticism that has arisen, primarily in Europe, of how the world's leading health organization responded to the first influenza pandemic in more than four decades.
"For WHO, its credibility has been badly damaged," wrote Fiona Godlee, the editor of the BMJ, a prominent British medical journal, that published one of the reports. "WHO must act now to restore its credibility."
A spokesman for the WHO, along with several independent experts, however, strongly disputed the reports, saying they misrepresented the seriousness of the pandemic and the WHO's response, which was carefully formulated and necessary given the potential threat.
"The idea that we declared a pandemic when there wasn't a pandemic is both historically inaccurate and downright irresponsible," said WHO spokesman Gregory Hartl in a telephone interview. "There is no doubt that this was a pandemic. To insinuate that this was not a pandemic is very disrespectful to the people who died from it."
The first report, released in Paris, came from the Social, Health and Family Affairs Committee of the Parliamentary Assembly of the Council of Europe, which launched an investigation in response to allegations that the WHO's response to the pandemic was influenced by drug companies that make antiviral drugs and vaccines.
"The parliamentary assembly is alarmed about the way in which the H1N1 influenza pandemic has been handled, not only by the World Health Organization (WHO), but also by the competent health authorities at the level of the European Union and at national level," the 18-page draft report states.
"It is particularly troubled by some of the consequences of decisions taken and advice given leading to distortion of priorities of public health services across Europe, waste of large sums of public money, and also unjustified scares and fears about health risks faced by the European public at large," according to the report.
The second report, a joint investigation by the BMJ and the Bureau of Investigative Journalism, which is based in London, criticized 2004 guidelines the WHO developed based in part on the advice of three experts who received consulting fees from the two leading manufacturers of antiviral drugs used against the virus, Roche and GlaxoSmithKline.
"We are left wondering whether major public health organizations are able to effectively manage the conflicts of interest that are inherent in medical science," the report states.
Hartl dismissed those charges.
"WHO would say categorically that it believes that it has not been subject to undue conflict-of-interest. We know that some experts that come to our committees have contact with industry. It would be surprising if they didn't because the best experts are sought by all organizations," Hartl said. "We feel that the guidelines produced were certainly not subject to undue influence."
Several other experts also defended the agency.
"Twenty-twenty hindsight can always second guess the decisions of public health officials," said Jeffrey Levi, executive director of the Trust for America's Health, a private nonprofit group. "But this kind of condemnation of public health officials who made the most prudent decisions based on available knowledge could well backfire in future emergencies: I fear that public health officials will draw the lesson that they should wait for greater scientific certainty before responding in the future -- and we could pay for that overcaution with many lives lost."
In response to the criticism, the WHO has launched two investigations, including one by an independent panel of experts led by Harvey Fineberg, who heads the Institute of Medicine at the U.S. National Academy of Sciences.
"These reports raise questions about potential, inappropriate influences on WHO decision-making in the assessment and response to the 2009 H1N1 pandemic and, more generally, question practices employed by WHO to guard against conflict of interest among its expert advisers," Fineberg said in an e-mail. "These topics are among those that will be fully considered by our review committee."
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World Health Organization Scientists Linked to Swine Flu Vaccine Makers 
