Will the scandal about undeclared industry ties of experts who advised the World Health Organisation on pandemic influenza claim the scalp of the Director-General, Dr Margaret Chan?
Such a question might have seemed far-fetched even just a few months ago, but no less an authority than the editor of the BMJ, Dr Fiona Godlee, has suggested this may be possible, given the scale of the “public cost and private profit” involved in the influenza pandemic.
Following a series of revelations about the WHO’s failure to effectively and transparently manage experts’ conflicts of interests, Godlee said there had been called for Chan’s resignation.
“It may come to that,” Godlee wrote at Twitter.
The latest issue of the BMJ reports on an investigation, jointly conducted by the journal with the Bureau of Investigative Journalism, which found that some of the experts advising WHO on the pandemic had financial ties with drug companies that were producing antivirals and influenza vaccines.
As an example, WHO’s guidance on the use of antivirals in a pandemic was authored by an influenza expert who at the same time was receiving payments from Roche, the manufacturer of oseltamivir (Tamiflu), for consultancy work and lecturing.
Although most of the experts consulted by WHO made no secret of their industry ties in other settings, WHO itself has so far declined to explain to what extent it knew about these conflicts of interest or how it managed them. They were not declared in relevant WHO publications, and it appears the organisation did not follow its own 2003 guidelines for handling conflicts of interest.
The BMJ says the “lack of transparency” is compounded by the existence of a secret “emergency committee,” which advised Chan on when to declare the pandemic—a decision that triggered costly pre-established vaccine contracts around the world.
Apart from the name of the Australian scientist who chairs the committee, Professor John Mackenzie, who was quoted recently in this Reuters article, the committee members’ identities are kept secret. The WHO has, however, said it plans to release the names once the committee’s work is finished.
Meanwhile, the Council of Europe has also been extremely critical of the WHO, with an inquiry concluding that decision making around the influenza A/H1N1 crisis has been lacking in transparency.
The Guardian cites a UK MP, Paul Flynn, who sits on the Council’s health committee as saying: “The tentacles of drug company influence are in all levels in the decision-making process.” He also said there had been “distortion of priorities of public health services all over Europe, waste of huge sums of public money and provocation of unjustified fear.”
The BMJ says WHO’s response to such concerns had been “disappointing” and a “knee jerk defence”.
The BMJ notes that the WHO will not be the only body to come under scrutiny for its handling of the pandemic, and that coming months will see a spate of reports, from the European Commission, the European Parliament, and from national bodies including the French Senate, and the UK’s Cabinet Office.
So far as I’m aware we won’t be seeing any such reports released in Australia. Not because experts’ ties to industry are not an issue here. And not because we can be sure the policy making process has been squeaky clean.
It’s more that all of the reviews and debriefings that I’ve heard about have been conducted behind firmly closed doors. No accountability or reporting back to the public in full. I gather that another such process is to be held soon.
Even experts who have been involved in providing advice to government have many questions about how policies were devised, and who has been involved in what decisions.
Meanwhile, the crisis engulfing the WHO has far bigger ramifications than simply pandemic influenza. It raises broader questions for public health and medicine about the role of experts with industry ties.
As one influenza expert said to Croakey in the last few days: “Just declaring conflict of interest then going on with life normally (ie, conflicted) is not the appropriate path. Experts who are in the pay of Big Pharma should excuse themselves from discussions about spending public money, not declare potential conflicts of interest, then go on with influencing decisions. The problem is that these people are genuinely expert and governments and other bureaucracies such as WHO like to have access to their expertise. But their expertise may not be unbiased.”
Godlee put it another way on Twitter: “We need to create a world in which the best, most respected, most sought after experts are those who are NOT in the pay of industry.”
These are not only issues for the WHO, or for pandemic influenza policy…
To me, it seems interesting that when it comes to vaccines, which have been so vital in radically reducing and in the case of smallpox, eliminating infectious diseases, that the normal conventions of declaring CoIs seem to be forgotten. It’s as if people have assumed that the vaccine industry could not reasonably be considered a competing interest worthy of declaration — they are so very much part of the solution to disease control, total partners with public health etc: almost the idea that the interests of public health and the vaccine industry are co-extensive, and so the idea of interests being “competing” or “conflicting” could never arise.
Plainly this is not the case. However, the treatment of this issue raises interesting problems.
If I were a public health infectious disease expert, engagement with the vaccine industry in mutual pursuit of reducing disease, would seem natural. Vaccines have so often been the cornerstone of reducing disease, so a deliberate decision to not engage with them with advice, independent expert review, strategy planning, intelligence sharing etc would be like a dietitian trying year round to facilitate improved diet in the population while refusing to have anything to do with the food industry which supplies to 99.99% of the community the very items of diet that dietitians urge be consumed more.
Competing interests arise when the interaction between outside experts and industries are accompanied by some form of benefit to the expert. But when you agree to provide such input to a company who stands to profit from your expertise, why should it be done for free or indeed at your expense, as if you were assisting a charity or non-profit community group? If the industry wants me to attend a meeting of theirs where there are travel and accommodation expenses involved, why should I pay myself to assist them?
The risks of odium now associated with having and declaring competing interests have become such that it must be intimidating many researchers into refusing industry engagement. I myself have not done so for nearly a decade as I value my independence. But I don’t think this is a healthy development.
One of the BMJ pieces argues that “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.” Links would be taken to include travel support, speaking fees and payment for the preparation of expert advice.
If this dictum was followed, would it not mean that only those experts who were prepared to assist industries by dipping into their own pockets should be considered truly impartial? Or those who subscribed to the view that any engagement with industry was inherently corrupting of independence? These seem radical separatist policies which would likely see not only very few experts eligible to serve on such guideline committees. Its reductio would be a peculiar kind of hypocrisy whereby we all left industries to independently get on with developing breakthroughs and improvements in foods, pharmaceuticals, vaccines, consumer safety etc, and then promoted and advised use of the winners. Treated industry like unscrupulous pariahs, except when they produced the goods.
One resolution to this would be if institutions like universities could adopt a system whereby industries wishing to avail themselves of independent expertise could contribute to a central funding pool, administered and governed entirely by the universities and research institutes, with no governance role from industry. Requests for engagement could be made via the funding pool administration, and all payment and reimbursement likewise handled All payments and expenses would be via the pool, not directly through a company or industry body. Such an arrangement would seem likely to reduce the extent to which researchers might be tempted into the sorts of lacks of judgment that can arise from being too close to a company or industry, while at the same time acknowledging the importance of industry engagement.
I agree with Simon Chapman. It is important not to get too fundamentalist about this. Almost by definition, medical experts are likely to have been asked by relevant drug companies for advice, or to participate in an education session. Who else should drug companies get independent clinical advice from? Conversely, receiving regular retainer-type payments from a drug company or owning shares in the company should probably make an expert ineligible to give advice to government.
Simon Chapman (who I greatly respect) wrote:
“To me, it seems interesting that when it comes to vaccines, which have been so vital in radically reducing and in the case of smallpox, eliminating infectious diseases, that the normal conventions of declaring CoIs seem to be forgotten. It’s as if people have assumed that the vaccine industry could not reasonably be considered a competing interest worthy of declaration”
Please note: WHO requires that such CoIs be declared by every expert advisor, consultant, or committee member. Here is a link to a typical WHO “declaration of interest form”: http://tinyurl.com/WHO-CoI-form
I can’t find a generic one on line, but I have filled out dozens of them myself, and the example in the link above is representative.
What was problematic about the “declaration of interests” in the WHO emergency committee wasn’t that WHO didn’t know about the conflicts, potential conflicts, or appearances of conflicts – WHO did know. The problem was that WHO chose not to make the names of the committee members public — for what I consider unjustified reasons.
To its credit, WHO adhered to its own Outbreak Communication Guidelines ( http://tinyurl.com/WHO-OCGs ) regarding transparency: The guidelines state that “Announcing the limits of transparency publicly, and explaining why those limits are being set, is usually well tolerated provided the limits are justified.”
However, in this instance, the reason given for the limits of transparency — “Our decision not to make these names public was motivated by a desire to protect the experts from commercial or other influences” (Director General Margaret Chan, http://tinyurl.com/unjustified-reason ) — is a pathetic and insulting justification.
The world’s top influenza experts don’t need that kind of protection. They are constantly surrounded by opinions and people lobbying for many commercial and other interests (and not just overtly corporate interests — also governmental commercial interests: Ministries of Tourism and Travel, Ministries of Foreign Affairs, Ministries of Agriculture, etc.)
These experts are very experienced in coping with this, and they are fully qualified to carefully assess and analyze such opinions and lobbying.
Rather than being protected through anonymity, the committee experts only need to be required to declare instances of efforts to influence them, just as they are required to declare other past or current conflicts of interest, potential conflicts of interest, or situations which may appear to be conflicts of interest.
Slightly off beam, but may I recommend Peter Sandman’s Empathic Communication in High-Stress Situations? As you can see, he uses an instance of “critics are claiming you hyped swine flu in order to push vaccination”.
It strikes me that lack of empathy is likely to derail all the good work put into proposals for reform of our health care system. If, at the top of the tree, only material that fits into a single A4 of Executive Summary will cut through, a lot of people will be disappointed. Depersonalisation is useful to form focus, but sooner or later the major interests have to eyeball each other. It seems a deficiency of normal human behaviour may be driving the current disagreements over taxation reform.
Anyway, I know what empathy sounds like. Listen to the ABC Classic FM Morning Interview (Margaret Throsby) for June 10th with Jonathan Gillis (NSW State Medical Director for Organ and Tissue Donation). The first thing Gillis admits is that he just learned something new about himself.
Update: You can read Margaret Chan’s response to the BMJ here: http://bit.ly/9P0aTC
Simon – I may not agree with much of what you have to say, but you have as much right as anyone to express your point of view. But in the interests of transparency I wonder why you do not also explain that you probably can afford to refuse industry engagement because you have shared in millions of dollars worth of government grants over the past few years.
Update: Ray Moynihan has a comprehensive wrap of recent pandemic history here:
And more detailed response from the WHO: http://www.who.int/csr/disease/swineflu/notes/briefing_20100610/en/index.html
“I’d really appreciate your opinion on our latest xpill”. The glossy lipstick almost blinding, the low-cut dress revealing just a little too much bosom for the dignity of a public hospital, and the high heels commanding attention of patients, families and staff alike. “Would you mind coming to a meeting to tell us about it, we really value your opinion” – cutsie but sophisticated glasses enhance the fluttering eyelids.
She knows I’m a junior registrar. Perhaps she’s buttering me up in case one day I become a strikingly important professor of something?
I see your point Simon, but with a bit of insider knowledge of what “we value your expert opinion” really means, and with the addition of things like childhood varicella vaccine to the national immunization schedule, it’s hard not to be a little cynical about the relationship of governments, experts and big pharma.