WHO and the pandemic flu “conspiracies”
BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c2912 (Published 04 June 2010) Cite this as: BMJ 2010;340:c2912
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An apocryphal saying states; "It is difficult to make predictions,
especially about the future". This is particularly true in relation to
the latest influenza H1N1 “pandemic”. While criticisms of WHO’s coyness
about full disclosure of the industry links of its chief influenza
advisers justifies criticism, we should not lose sight of the fact that
inadvertent wastefulness of human and financial resources for community-
wide emergency preparedness and response is the leitmotiv of public health
history. International migration laws no longer allow for mass
evacuation, a common public health approach adopted during the health
protection era.1 Even in our contemporary era, Rose extrapolates from
Framingham study data to suggest that if all men up to age 55 reduced
their cholesterol level by 10%, one in 50 could expect to avoid a heart
attack on average yet 49 out of 50 would consume statins and eat
differently every day for 40 years and perhaps get nothing from it.2
What is new about the influenza preparedness is not the waste of funds,
but the current influential stakeholders – priests, herbalists and opinion
leaders have been replaced by pharmaceutical industry executives and
researchers who have close research & financial links with them.
Furthermore, while wasteful practices associated with public health
preparedness in previous centuries tends to be fairly circumscribed to
specific communities, the 21st century avatar of public health is more
global. Hence the risk of wasteful spending is much higher. In relation
to cost, it is well known that disease outbreaks with patchy and irregular
distribution are poor value for global health interventions. We showed,
for example, that in patchy prison influenza outbreaks, it was less costly
to do nothing other than conservative treatment than to mass vaccinate
prisoners annually.3 Thus, those who consider WHO a prime candidate for
the “night of long knives” should take note of the public health framework
within which they were operating. Hindsight is always better than
foresight when it comes to implementing global infectious disease control
strategies.
References
1) Awofeso N. What is new about the ‘new public health’?. American
Journal of Public Health, 2004; 94: 705-9.
2) Rose G. Strategy of prevention: lessons from cardiovascular disease. Br
Med J 1981;282:1847–51.
3) Awofeso N., Rawlinson W. D. Influenza control in Australian prison
settings: cost-benefit analysis of major strategies. International
Journal of Prisoner Health, 2005; 1: 25-31.
Competing interests:
None declared
Competing interests: No competing interests
Dr Chan claims that "The bottom line, however, is that decisions to
raise the level of pandemic alert were based on clearly
defined...criteria. It is hard to bend these criteria, no matter what the
motive."
In that case, Dr Chan needs to explain why she has failed to follow
these clearly defined criteria.
The "clearly defined criteria" for the POST-PEAK PERIOD is that
"Levels of pandemic influenza in most countries with adequate surveillance
have dropped below peak levels." This will result in "Evaluation of
response; recovery; preparation for possible second wave."[1]
The "clearly defined criteria" for the POST-PANDEMIC PERIOD are,
"Levels of influenza have returned to the levels seen for seasonal
influenza in most countries with adequate surveillance."
In May, WHO produced a series of graphs proving beyond doubt that
the WHO criteria had been met for downgrading the 'pandemic' from Phase 6,
to at least the post peak phase or even the post-pandemic phase.
Can Dr Chan please explain the motive that lead to WHO bending its
own 'clearly defined criteria' by not down-grading the 'pandemic' alert in
February and again in June? [3, 4]
The absence of a rational explanation adds further weight to claims
of industry influence, and dilutes Dr Chan's 'perfectly clear' response.
[1] http://www.who.int/entity/csr/disease/influenza/PIPGuidance09.pdf
[2] WHO Influenza update 28 May 2010,
www.who.int/csr/disease/swineflu/Virologicaldata2010_05_28.pdf
[3]
http://www.who.int/csr/disease/swineflu/7th_meeting_ihr/en/index.html
[4]
http://www.who.int/csr/disease/swineflu/8th_meeting_ihr/en/index.html
Competing interests:
None declared
Competing interests: No competing interests
World Health Organization Director-General Margaret Chan [1] has
missed the point of Cohen and Carter’s article [2]. Chan’s claim that
commercial interests did not enter her decision making is not reassuring.
We know that WHO has long term relationships with industry [3,4],
relationships which conceive of industry as a “partner” [5]. The point is
not whether Chan herself feels to have been influenced or not; the point
is that transparent declarations of interest are crucial to let everybody
else—notably government officials, doctors, and the public—decide for
themselves. What Cohen and Carter show is that WHO chose not to disclose
financial conflicts of interest among experts that the Organization tapped
for guidance.
This "we know best" culture seems to be prevalent at WHO. In December
2009, we published the latest update of our Cochrane review of
neuraminidase inhibitors alongside a six month BMJ-Channel 4 investigation
[6-8]. These articles cast serious doubts on most of the evidence of the
effects of oseltamivir (Tamiflu), called into question various government
pandemic preparedness planning assumptions, demonstrated evidence of very
substantial publication bias, revealed multiple inconsistencies across
different versions of the same dataset, discovered the presence of ghost
authors in some of the original published trials and at least one instance
of guest authorship of a key piece of evidence.
WHO dismissed the relevance of our review within hours of its
publication on BMJ.com: "This will not change our (Tamiflu) guidelines," a
WHO antivirals expert told the press [9]. The WHO spokesperson for H1N1
declared: "We need to make very clear that what Cochrane was looking at
was seasonal influenza, it was not H1N1" [10]. The 'we know best' ethos
seems to ignore the fact that oseltamivir is licensed for all types and
subtypes of influenza A and B (and the H1N1 virus is simply a new
influenza A virus).
These matters are not idle debate. Decisions made by WHO were
crucial in propelling the expenditure of public money to the tune of
billions. Cohen and Carter have done public health a great service in
helping restore accountability, and should be congratulated on their
courageous work.
Tom Jefferson and Peter Doshi
Cochrane Acute Respiratory Infections Group
References:
1. Chan M. WHO response to article on conflicts of interest. BMJ
Rapid Response [Internet]. 2010 Jun 8 [cited 2010 Jun 8];Available from:
http://www.bmj.com/cgi/eletters/340/jun03_4/c2912#236800
2. Cohen D, Carter P. WHO and the pandemic flu "conspiracies". BMJ.
2010 Jun 6;340(jun03_4):c2912.
3. World Health Organization. Global pandemic influenza action plan
to increase vaccine supply [Internet]. 2006 Sep;Available from:
http://www.who.int/entity/csr/resources/publications/influenza/CDS_EPR_G...
4. WHO Expert Working Group on R&D Financing. Report on EWG (draft)
[Internet]. 2009;Available from:
http://mirror.wikileaks.info/wiki/leak/ewg-ifpma-reports-comms/ewg-report-
draft-20-11-09.pdf
5. Fukuda K. Statement by Dr Keiji Fukuda on behalf of WHO at the
Council of Europe hearing on pandemic (H1N1) 2009 [Internet]. 2010 Jan 26
[cited 2010 Mar 24];Available from:
http://www.who.int/csr/disease/swineflu/coe_hearing/en/index.html
6. Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors
for preventing and treating influenza in healthy adults: systematic review
and meta-analysis. BMJ. 2009 Dec 8;339(dec07_2):b5106.
7. Doshi P. Neuraminidase inhibitors--the story behind the Cochrane
review. BMJ. 2009 Dec 8;339(dec07_2):b5164.
8. Cohen D. Complications: tracking down the data on oseltamivir.
BMJ. 2009 Dec 8;339(dec08_3):b5387.
9. CBS/AP. Experts Question Effectiveness of Tamiflu [Internet]. 2009
Dec 8 [cited 2009 Dec 8];Available from:
http://www.cbsnews.com/stories/2009/12/08/health/main5939496.shtml?tag=c...
10. Nebehay S. WHO backs findings on Tamiflu for seasonal flu
[Internet]. 2009 Dec 10 [cited 2009 Dec 11];Available from:
http://www.reuters.com/article/idUSGEE5BA0UY20091211?type=marketsNews
Competing interests:
We are co-authors of the relevant Cochrane review.
Competing interests: No competing interests
Following seeing my nephew regress into severe autism within days of
receiving the MMR jab nearly 15 years ago I have, over the last ten years
or so, become moderately interested in the subject of vaccines, their pro
and cons, and the rational and justification for their introduction.
Whilst I am not anti-vaccine per se I am, however, sceptical of the
fear instilling rhetoric used by governments and their advisers in order
to what I see as an ultimately counterproductive attempt to try and
rebuild public confidence in vaccines following the widespread controversy
over the safety of the MMR.
Is it mere coincidence, therefore, that, following the SARS and Bird
Flu scares, a medical novice such as myself was confidently aware as far
back as 2004 that the general public would be told sooner or later that
unless they trusted the experts they and their families were in mortal
danger of a 'Flying Pig Flu' unless they accepted mass vaccination, albeit
unnecessarily and with a risk adverse reaction in a minority of
recipients?
I am deeply concerned about this 'pandemic that never was' because it
would seem the next time I hear our governments and their advisers cry
wolf I may be far less inclined to believe them than I was when they told
us about Saddam's nonexistent WMD's.
Competing interests:
Not riding the gravy train.
Competing interests: No competing interests
In her editorial Dr. Godlee uncovers a series of conflicts of
interests that were not declared when decisions were taken concerning the
therapeutic and preventive actions to be adopted during tha swine flu
pandemics (1).
On the other hand, it could be argued that the precautionary principle has been
applied and this could be agreed, if the same caution would normally apply
in other medical fields such as the prevention of adverse drug reactions.
In fact, the causality relationship between drug administration and
adverse reaction has to be demonstrated beyond every reasonable doubt
before precautionary measures are taken.
Rofecoxib case taught that precautions can arrive very late only
after striking evidence of adverse effects (2). Instead, the swine flu
lesson is that a scientific review of available evidence has always to be
carried out, in order to avoid decisions taken on the basis of emotion or
interest.
References
1. Godlee F. Conflicts of interest and pandemic flu. BMJ 2010;340:c2047
2. Dieppe PA, Ebrahim S, Martin RM, Jüni P. Lessons from the withdrawal of
rofecoxib. BMJ. 2004 Oct 16;329(7471):867-8
Competing interests:
None declared
Competing interests: No competing interests
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.
You argue 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.
Competing interests:
I own 400 shares in CSL
Competing interests: No competing interests
There's an old saying--"just because you're paranoid doesn't mean
they're not
out to get you." It crossed my mind on reading Dr. Chan's dismissal as
"conspiracies" of the widespread concern that industry influenced WHO's handling
of
the H1N1 pandemic.
Maybe some people do see it as a conspiracy. But that, in and of
itself, does not
mean there was no such influence, or that people who are concerned about
its
potential are delusional.
Competing interests:
None declared
Competing interests: No competing interests
It was clear at the time, as it is now, that the decision to embark
on population wide vaccination was "based" on inadequate evidence of
efficacy and ignorance of adverse effects. Attempts to draw attention to
this were suppressed or castigated as sabotage of an attempt to protect
the world peoples. As an example, I sent a question to the BMJ's public
discussion with Liam Donaldson: What is the number of vaccinations needed
to prevent a) one case and b) one death? This was not addressed though the
presenter was keen to elucidate the emotional strain the Chief Medical
Officer was under. We still have had no answer after billions of pounds
have been spent. Nobody has been held responsible for this appalling
fiasco.
Competing interests:
None declared
Competing interests: No competing interests
In their well researched and written article, Cohen and Carter show a
lack of public disclosure on financial conflicts of interests has been a
problem. Another major issue is the difficulty for the general public to
know who are the individuals giving advice and thus what links they may
have to the Pharmaceutical industry. It is imperative that we have much
better disclosure in the public arena on all this issues. This is not only
for the involvement of individuals or companies with organizations such as
WHO, but also individuals’ involvement with governments. Billions of
dollars have been spent around the world by governments to purchase
influenza vaccines and antivirals. Many Pharmaceutical companies had very
high profit margins on these sales (1).
They however have one statement that I think is incorrect; “in
Australia and New Zealand showed that only about one to two out of 1000
people were infected.” I suspect their figure is derived by only using
laboratory confirmed cases (e.g. those PCR positive). However for each
laboratory diagnosed case there were likely to be another 100 people or
more with influenza infections but which was generally mild or even
asymptomatic. In New Zealand and in the US more than 10% of population
were likely infected (2,3).
In some groups (e.g. pregnant women) there was a much higher
complication rates than expected but overall the virulence of the virus
has been low. In most people with infection is has mild. This was evident
very early on in the epidemic and before governments needed to make
decisions on whole of population vaccination campaigns (4). The fact that
this infection has already infected a large proportion of the population
but was in general with only very mild for the vast majority, strengths
the argument of Cohen and Carter in asking why the important issue of
severity was not taken into account and the WHO definition for pandemic
influenza was changed only relatively recently to remove this important
and indispensible factor.
The unnecessary high level of fear generated about swine flu lead to
hasty decisions such as the vaccination of entire populations (4,5). This
was despite the lack of adequate data or studies to show whether more
benefits than harm would likely result from immunizing people with no risk
factors (6, 7, 8). In Australia considerable harm has occurred in very
young children who were vaccinated recently (9). About 1 in 110 of these
children had febrile convulsions. An increased risk for seizures in this
age group should have been predictable from the data already available (as
limited as it is) (6). In young children over 30% develop fevers after
receiving either seasonal or pandemic H1N1 vaccines (from multiple
different companies). One could have expected a predictable proportion of
young children with fever would develop a febrile seizure. It remains a
concern that a population campaign to vaccinate very young children for
the upcoming northern hemisphere winter will continue in America, Europe
and elsewhere despite this recent Australia experience. There are only
small and inadequately powered studies to identify safety problems in
children and there does not seem to be in place proactive early warning
systems (e.g. following the first few thousand children vaccinated) so
that if serious or frequent problems are identified, the vaccine roll out
can be quickly halted before millions of children receive the vaccine (6).
We need more transparency, not only on conflicts of interest that may
be present, but also on the vaccine data to better judge the potential
harm that interventions might cause following the implementation of
experts’ advice to the WHO and Governments.
References
1. Harrison A. Australia's CSL profit up 63 pct on flu vaccine. Dow
Jones Newswires. August 19th 2009
http://www.google.com/hostednews/afp/article/ALeqM5ivnuEJD8PEh1phMBR9mNm...
2. Baker MG, Wilson N, Huang QS et al. Pandemic influenza A(H1N1)v in
New Zealand: the experience from April to August 2009. Euro Surveill.
2009;14(34):pii=19319.
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19319
3. Updated CDC Estimates of 2009 H1N1 Influenza Cases,
Hospitalizations and Deaths in the United States, April 2009 – April 10,
2010. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm
4. Collignon PJ. Swine flu - lessons learnt in Australia. Med J Aust.
2010;192:364-5.
http://www.mja.com.au/public/issues/192_07_050410/col10154_fm.html
5. Collignon P. H1N1 immunisation: too much too soon? Aust Prescr
2010;33:30-1
http://www.australianprescriber.com/magazine/33/2/30/1/
6. Collignon P, Doshi P and Jefferson T. Adverse events following
influenza vaccination in Australia--should we be surprised? (7 May 2010)
http://www.bmj.com/cgi/eletters/340/may04_2/c2419#235364
7. Jefferson T, Smith S, Demicheli V, Harnden A, Rivetti A. Safety of
influenza vaccines in children. Lancet. 2005 Sep 3;366(9488):803-804.
8. Jefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V.
Vaccines for preventing influenza in healthy children. Cochrane Database
Syst Rev. 2008 Apr 16;(2):CD004879.
http://www2.cochrane.org/reviews/en/ab004879.html
9. Bishop J. Seasonal flu vaccine remains suspended for young
children without risk factors. Press release. 1 June 2010. Australian
Government. Department of Health and Aging. Canberra.
http://www.health.gov.au/internet/main/publishing.nsf/Content/mr-yr10-dept
-dept010610.htm
Competing interests:
None declared
Competing interests: No competing interests
Missing in Action: WHO's Risk- Benefit Analysis
WHO has now published a formal response to the BMJ and other
"critics" on its website. (1)
WHO appears to acknowledge its failure to disclose conflicts of
interest by experts involved in writing its 2002-4 pandemic plan.
However, WHO speaks with forked tongue on the issue of dropping
pandemic severity from its definition. WHO states,
"WHO regards severity as an important feature of pandemics and a
critical factor when deciding on which actions to take. However, WHO has
not required a set level of severity as part of its criteria for declaring
a pandemic."
WHO's excuse is paradoxical, since by declaring a level 6 pandemic,
significant and expensive actions were triggered around the world.
Removing severity from the way pandemic levels were defined created a
definition that was both meaningless and misleading, in terms of the
response it generated.
Granted that Dr. Chan made her decision in the absence of commercial
interests. But what other factors induced her to declare a level 6
pandemic for what she admits was a fairly minor illness, and to retain
that definition even now?
WHO further states,
"The new H1N1 virus rapidly crowded out other circulating influenza
viruses and appears to have displaced the older H1N1 virus. This
phenomenon is distinctly seen during pandemics."
But if WHO and national experts recognized this phenomenon, why did
they continue to advise use of both seasonal and swine flu vaccines?
Shouldn't WHO have issued an advisory that only the swine flu vaccine was
necessary?
IN the US, more seasonal flu vaccinations were administered during
that 2009-10 flu season than ever before. CDC has built on this 'triumph'
and is recommending seasonal flu vaccinations for everyone aged over 6
months in the US for upcoming flu seasons.
Yet CDC acknowledged as of January 2010, "Very few seasonal influenza
viruses have been isolated and analyzed at CDC." (2) Over 99% were swine
H1N1 influenza.
Where is the risk-benefit analysis of WHO and CDC? CDC recommended
seasonal flu inoculations throughout last year's flu season, although it
soon became apparent that the vaccine had no efficacy against the only
circulating strain.
CDC has ignored the safety issue identified in Australia and
discussed by Collignan above (1/110 young children had a seizure post-
vaccination) for the 2010 seasonal flu vaccine, even though seasonal flu
vaccine has been withdrawn for under-5's in Australia.
It's past time for these "normative" public health organizations to
fully explain their decision-making processes to those of us on whom their
illogical policies are imposed, and who pay the costs (and their
salaries).
1.
http://www.who.int/csr/disease/swineflu/notes/briefing_20100610/en/index...
2. http://www.cdc.gov/flu/about/season/current-season.htm
Competing interests:
None declared
Competing interests: No competing interests