In October 2002, 22 scientists, nine WHO secretariat members and two drug industry representatives, met in Geneva to draw up draft guidelines on the use of antivirals and vaccines for influenza. [1]


These formed the basis of advice issued to the world two years later. Included in this were three annexes, each drawn up by an eminent scientist present at the original meetings.



The WHO would be expected to examine any financial links these three scientists – and any others advising it - might have with pharmaceutical companies. It says it did, but it’s refusing to make public the details.




In 2004 this guidance was distributed[2] to nations as the definitive thinking on pandemic planning.


It was a stamp of approval that helped spark a worldwide rush for the drugs.


Around ten billion dollars have since been spent on Roche’s drug Tamiflu[3], and another $2bn on rival Relenza, made by GSK.  



Our investigation has learnt that Annex preparer[4] Professor Hayden was receiving funds from Roche until late 2004[5].


He’s made declarations of being a former consultant for the drug company; of being a member of Roche’s speaker’s bureau; and of receiving grants and research support.[6]


At a press conference last year, he spoke about his paid work from Roche and others up to 2004:


Professor Frederick Hayden

Speaking Nov 2009


I actually was an investigator and at one time a paid consultant for Roche and some other companies also including GSK and others that were involved in antiviral and drug or vaccine development.



As a scientist Professor Hayden routinely declares his ties with pharmaceutical companies – even if the WHO does not. He told us that he has always


striven to use my role as an advisor to these companies as an opportunity to help direct the development of more effective interventions for influenza and other respiratory viruses



Another scientist supporting antiviral stockpiling at the World Health Organisation in 2002 and 2004 was Professor Karl Nicholson, based at the U.K.’s University of Leicester.[7]



In 2003, we’ve learnt, Professor Nicholson declared previous funding from antiviral drug makers – details the WHO chose not to release.[8]



Up to 2001 he had been paid “ad hoc consultancy fees by Roche”


He received speaking fees and research funding from Roche and rival GSK.


And he’d been paid by GSK as a consultant to help develop their own antiviral, Relenza.


Professor Nicholson told us he received “no more than a few hundred pounds” for his work with Roche.



And he told us:


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.  [9]


The final authored annex in those 2004 guidelines was prepared by Professor Arnold Monto of the University of Michigan.


That same year he declared a “professional relationship” with, among others, Roche.[10]


Once again, despite Professor Monto openly declaring his pharmaceutical industry links elsewhere, the WHO chose not to make this information public. 



In a detailed email response to our questions, Professor Monto told us that the WHO:


have always impressed me as being keen to avoid situations where even an appearance of conflict can occur, especially in terms of funds or products accepted by the organization.”[11]


Dr Fiona Godlee

Editor, BMJ



It’s clear that all of those people have, at various times, declared these conflicts and it wouldn’t have taken really any work at all for the WHO to know about them, so one has to assume that the WHO did know, or was really making no effort to find out. And if they did know then I think it’s really odd and unacceptable that WHO should use these people as key contributors to the major international guidelines on the pandemic.



WHO’s rules in 2002 and 2004 required declarations to be filled out relating to possible conflicts going back three years. 


If there is a conflict, advisers are supposed either not to take part at all; to stay out of sensitive discussions; or to take part, but have their conflicts of interest disclosed.[12]



Deborah: So you don’t know if those specific individuals filled out declarations of interest forms?


Hartl: Declarations of interest were asked for from all participants yes.


Deborah: And do you know if those specific individuals signed a declaration of interest form?


Hartl: I’m not 100% sure but I believe they did, but I’m not 100% sure.







The WHO has told us that a Declaration of Interest statement exists, relating to the 2002 and 2004 antiviral and vaccine meetings.


But WHO Director General Margaret Chan’s office refuses to release to us any details of the Declarations.


Gregory Hartl

WHO spokesman





Hartl: We have to balance all the time the privacy of the individual vs the robustness of the guidelines//


DEB: If the declarations of interest were taken then arguably you could find out whether they did have conflicts of interest?


Hartl: I really…that’s something that I would have to investigate and get back to you on. I really can’t answer that at this point.



In its latest advice on influenza antivirals and vaccines, the WHO has published declarations of interest.


We now know, for example, that Professor Arnold Monto has recently received between $3,000 and $10,000 in consultancy work for GSK. [13]


Professor Hayden, too, declares his work as an unpaid consultant for both companies, among others.[14]



The WHO recently described potential conflicts of interest as “inherent in any relationship”, but says that it protects against undue influence[15] 


Yet a new Council of Europe report into last year’s ‘swine flu’ pandemic also raises concerns about transparency at the WHO, and the risks of undue pharmaceutical company influence. 


Dr Fiona Godlee,

Editor, BMJ


There will be people who interact with industry - that’s perfectly acceptable. We need to have good interaction between industry and public health industry with clinical medicine. But to be paid consultants, to be people who are actually on the payroll, to be people who actually published or spoken at promotional events for the company – I think that really is way too far over onto the unacceptable side of things.






[1] WHO 2004 Guidelines – Annex 2 – List of participants 2-4th Oct 2002 

[2] WHO 2004 final guidelines“sent to all WHO regional advisors, who channel the information to country offices. Each country office will then share the information with that country’s Ministry of Health.” Note from WHO to Emma Slater 21/5/2010

[3] $9.8bn sales declared by Roche since Jan 2004 – current exchange rate

[4] Caution with title: cited as preparing the Annex. Nicholson informed Angus S in a phone interview that he had consulted widely with other panellists from an October 2002 symposium

[5] ‘at this time’ – Hayden indicated to C4 News in 2009 [unbroadcast] that he was working for Roche as a consultant late 2004/ early 2005 [timeline not clear]. We also have COIs for him from as late as 2007 declaring a Roche interest, which probably refer to three years earlier. He continues to advise Roche unpaid. In a telephone interview with Chris Woods 20/5/10 he stated that “according to my records my last payment [from Roche] was 2004”.

[6] ISDA financial disclosure 6-9th Oct 2005

[7] Nicholson’s phone conversation with Angus Stickler confirms he both made a slide presentation in 2002 in support of antivirals, and endorsed stockpiling

[8] Need to clarify with Nicholson when this applies to. COI Professor Karl Nicholson hereby declares the following potential conflicts of interest: (i) has been paid ad hoc consultancy fees by Hoffman La Roche Pharmaceuticals; (ii) has been paid ad hoc consultancy fees by Wyeth concerning clinical evaluation of live-attenuated, cold-adapted influenza vaccine; (iii) has received reimbursement (travel and hotel accommodation) for attending the international launch of zanamivir in Prague, November 1999, from GlaxoSmithKline; (iv) has received fees for speaking from both GlaxoSmithKline and Hoffman La Roche Pharmaceuticals; (v) has received fees for chairing a symposium from Wyeth; (vi) has received fees for research from (a) Chiron for work on avian influenza vaccines, (b) Aventis Pasteur for work on the epidemiology of RSV in the elderly and (c) Wyeth for work on the epidemiology of influenza in children; (vii) has received consultancy fees from Johnson & Johnson, who no longer have an interest in neuraminidase inhibitors; (viii) has received (prior to the last 3 years) consultancy fees from GlaxoSmithKline in relation to the clinical development of their neuraminidase inhibitor; (ix) his research group has received (prior to the last 3 years) funds for research from both GlaxoSmithKline and Hoffman La Roche to participate in multicentre clinical trials of neuraminidase inhibitors; and (x) was a founder member and Vice- Chairman of the European Scientific Working Group on Influenza (ESWI – a group of European scientists promoting the study of influenza); the group is supported by vaccine manufacturers and Hoffman La Roche and GlaxoSmithKline, but is scientifically independent of the sponsorship. He is no longer an ESWI member.   HTA November 2003


[9] Nicholson Right of Reply response

[10] In 2004, Monto declared a “professional relationship” with the following: Aventis: Investigator; Aventis Pasteur, Inc.: Research Support; Chiron: Consultant/Advisor; Lederle Pediatrics and Vaccines: Consultant/Advisor MedImmune: Consultant/Advisor, Investigator; Roche: Consultant/Advisor, Investigator;  Roche, Inc.: Grant recipient/Research support (42nd ANNUAL MEETING OF IDSA, SEPTEMBER 30 – OCTOBER 3, 2004 – BOSTON, Financial Disclosures


[11] Monto email to Woods 27/5/10

[12] Ibid

[13] WHO Rapid Advice Guidelines… August 2009; updated February 2010

[14] WHO Rapid Advice Guidelines… August 2009; updated February 2010

[15] WHO Pandemic (H1N1) Briefing Note 19 – 3rd Dec 2009


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