Additional questions about the H1N1 scandal

On 28 April, 2009, when I was asked by the French international news channel to participate in a debate on the then hot topic of “pandemic” flu, my first answer was to refuse due to my lack of relevant skill in virology or infectious diseases (not to speak of a reluctance to improvise live in English…) Having finally accepted the invitation on the basis that we would be discussing the matter from the perspective of vaccine development, I did not consider myself to be displaying any extraordinary expertise in pointing out the following matters straightaway [1]: 1. There have been “previous instances” of false alarms, such as avian flu (1’32); 2. “this precedent of avian flu casts important doubts on the credibility of health agencies, national or international” (5’45); 3. “the real question is: who may have an interest in spreading alarming news?” (6’00); 4. viral mutation has been a regular occurrence in the history of flu without triggering such media alarm: what has changed is simply the availability of vaccine and antiviral drugs, the efficacy and safety of which remain to be documented (9’50).

In the companion debate recorded in French on the same day [2], I added that: i. there was no evidence of a major virulence associated with the new virus and the 200 reported Mexican deaths needed to be confirmed (they were reduced to a total of seven the following day); ii. the precedent of 1918 was clearly not relevant; iii. the official information on this new epidemic was a “rhetoric of intimidation”; iv. the conflicts of interest of the involved experts should be taken into consideration.

Taking as read that this analysis – by a non-expert – has now largely been confirmed, esp. by the recent BMJ/The Bureau of Investigative Journalism’s inquiry, the first question that presents itself is: why did the health profession take so long to detect the trick?

A second question might be: why did it take so long to get the measure of how the WHO goes about its business? Is it clearly understood now that the scandal of the H1N1 pandemic was just a re-run of other, older stories (which go far beyond the vaccine sector)?

In 1997, in a widely circulated French journal [3], a Beecham’s business manager claimed: “We started increasing the awareness of the European Experts of the World Health Organization about hepatitis B in 1988 [emphasis added]. From then to 1991, we financed epidemiological studies on the subject to create a scientific consensus about hepatitis being a major public health problem. We were successful because in 1991, WHO published new recommendations about hepatitis B vaccination.” This speaks of exactly the same process as that which was uncovered by the BMJ/The Bureau of Investigative Journalism’s inquiry, namely: 1. WHO’s experts seem to need manufacturers’ salesmen to become “aware” of significant health problems; 2. recognition of “a major public health problem” involves commissioning epidemiological studies whose conclusions are apparently predetermined (“we financed epidemiological studies on the subject to create a scientific consensus”); 3. “new recommendations” are the main medium by which such commercial manipulations are effected, the long-term accuracy of which may be measured by the contrast between the initial skepticism of the BMA [4] and the views it expressed on the topic subsequently [5].

Moreover: exactly as in the case of the SAGE experts group, I have repeatedly pointed out regarding the benefit/risk ratio of the hepatitis B vaccination that the “WHO voice” was actually that of the Viral Hepatitis Prevention Board (VHPB), which was created, sponsored [6], and infiltrated by the manufacturers. Once again, in its “Technical consultation on the safety of hepatitis B vaccines” (Geneva, 28-30 Sept, 1998) – which (adding to unreliable epidemiological studies) was a major piece in the fight-back of manufacturers against growing evidence of vaccine hazards – the VHPB even did not try to make out that the manufacturers’ employees - some of them completely devoid of any expertise in the fields in question - had been invited as “observers”. They were simply listed as “participants” in the “technical consultation”, like all the other participants.

A third question is related to the role of the regulatory agencies like the EMEA or the FDA, which – in contrast to the WHO – have the regulatory power of decision. This should be an opportunity to ask how, during the development of a vaccine targeted against a disease as mild as the H1N1 flu, the recording of no fewer than seven deaths in about 2000 healthy persons receiving Pandemrix as a test drug was regarded as acceptable, or that the statistical power to detect adverse events with the new vaccines did not go beyond…1% of exposed subjects (there is a worrying consensus in certain quarters that a serious audit of EMEA processing should not take place [7]). Furthermore, this could be an opportunity to review the progressive drift in European legislation which now permits the development of a new flu vaccine simply to be treated as a type II variation, an incredible regulatory coup for manufacturers. And to understand the recent history of the development and registration of H1N1 vaccines as a precedent for other future regulatory situations that will be governed by the new European directive amending, as regards pharmacovigilance, Directive 2001/83/EC - a regulation which would be nothing short of a disgrace.

A last question arises from the following observation: in this recent story of swine flu, whose financial stakes for manufacturers the manufacturers did not even attempt to deny (see media on economy), nobody heard the manufacturers’ voices in the promotion of swine flu as a major threat to public health consisted entirely of national and international health or governmental agencies. This illustrates JK Galbraith’s recent thesis on The Predator State [8], namely that “deregulation” is not the law of jungle for the lobbies’ benefit, but the surrendering of the State’s power and prerogatives to those lobbies, whatever the cost to public health or finances (see, for example, in France, requisitioning in the desperate hope of liquidating the vaccine stocks).

Finally, the H1N1 scandal is a new opportunity to challenge the view that conflicts of interests do not threaten experts’ independence as their links to commercial enterprises are simply the price of their scientific excellence. I would make the following points. First, this self-serving claim of independence is contradicted by a heap of published data, in particular data related to the sometimes subtle determinants of the “funding effect”. Second, firms and lobbies have the power to select who they think deserve to be recognized as an “expert”; excellence of itself is by no means the determinant of this selection [9].

The attached histogram summarizes the evolution of my turnover from the time I was a respected (and well-off) consultant to the leaders of pharmaceutical industry who were my clients until today. The interesting detail is that between 2000 and 2006 I was commissioned as an expert by French Judges on a number of occasions in litigation involving pharmaceutical companies and some of my expert reports received wide media coverage. Another detail of potential relevance is that, on the whole, these reports were less favourable to the interests of my clients than the recommendations of “independent” experts regarding swine flu.

References

1. France 24 International News. Swine flu: unfounded panic? 28 April, 2009, http://www.france24.com/en/20090428-wbenfaceoff12h12m090428flv- girard-bader-swine-flu-media-panic-real

2. France 24. Grippe : des peurs irrationnelles ? 28 April, 2009, http://www.france24.com/fr/20090428-grippe-porcine-epidemie-oms

3. Labbé C, Le Taillanter M, Recacens O, et al. L’habile stratégie d’un labo. Sciences et Avenir, January 1997, p 27.

4. D Carnall. Shire Hall. Communication and the case for hepatitis B immunization. BMJ 1996; 313: 825

5. AJ Pollard. Hepatitis B vaccination. BMJ 2007;335:950 (10 November), doi:10.1136/bmj.39315.677396.BE

6. Anon. Good news on hepatitis B vaccination in Europe. Scrip 1997(2288):22.

7. M Girard. No H1N1 enquiry committee in the European Parliament; http://www.rolandsimion.org/spip.php?article139〈=en

8. JK Galbraith. The Predator State. New York, Free Press, 2008

9. Girard M. Expert mongering, Br Med J, 11 Aug. 2004.

Competing interests: Marc Girard is or has been consultant for pharmaceutical firms, including most of those currently involved in the H1N1 scandal