The 2009 Flu Pandemic Scare Revisited

May 17, 2011
By

Journalist Helen Epstein in the latest New York Review of Books has produced a valuable look back at the 2009 H1N1 pandemic flu scare, leading Afghanistan to quarantine its only pig — only one of several absurdities costing the world economy billions of dollars in lost economic activity through reduced tourism, slain farm animals and unnecessary stockpiling of medical supplies. One group that benefited from the pandemic scare, however, was the global pharmaceutical industry, especially Hoffmann-LaRoche, which sells the marginally effective anti-influenza drug Tamiflu.

When the pandemic didn’t appear (global flu deaths in 2009 fell to less than 20,000 persons, making it one of the milder flu seasons on record), it left European and other governments with stockpiles of drugs and vaccines worth hundreds of millions of dollars. They began asking questions:

In March 2010, a Council of Europe report concluded that the H1N1 virus was known to be mild well before the WHO issued the pandemic “declaration” and expressed concern about the influence of powerful pharmaceutical companies over decision-making at the agency. A draft of the WHO’s response was released in March 2011. It calls for more “transparency” but concludes that “no critic of WHO has produced any direct evidence of commercial influence on decision-making.”

Epstein rebuts that finding. She cites the case of Roy Anderson, a prominent British epidemiologist and adviser to both the WHO and the UK government, who “gravely warned a BBC radio audience that only Relenza (a flu medicine made by GlaxoSmithKline) and Tamiflu would prevent a catastrophe on the scale of the 1918 influenza pandemic. At the time, Anderson was receiving £116,000 per year from GlaxoSmithKline.” She concludes:

During the ten years leading up to the pandemic declaration of 2009, scientists associated with the companies that were to profit from the WHO’s “pandemic preparedness” programs, including Roche and GlaxoSmithKline, were involved at virtually every stage of the development of those programs. The companies funded the documents giving guidance on preparing for the influenza pandemic, in which the WHO recommended the stockpiling of Tamiflu and Relenza. Consultants drafted parts of these documents and joined WHO officials in fund-raising for the Tamiflu stockpile. Industry-supported scientists were also on the committee that issued the “pandemic emergency declaration.” That announcement caused developing countries to request assistance from the WHO’s Tamiflu stockpile fund, and these requests contributed to a tripling of the drug’s sales in 2009. By declaring a pandemic and linking the response to Tamiflu stockpiling, the WHO could not have done a better job of promoting Roche’s interests.

The U.S. spent $3.2 billion in pandemic flu preparations in 2009, she writes. Perhaps it’s time for someone to investigate the Centers for Disease Control and Prevention decision-making during this period to see if similar conflicts of interest were involved here.

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4 Responses to The 2009 Flu Pandemic Scare Revisited

  1. Vasiliy Vlassov on May 23, 2011 at 8:28 am

    WHO independence
    Vasiliy Vlassov, MD, Professor, First Moscow State Medical University, President, Society for Evidence Based Medicine, vlassov@cochrane.ru
    The evaluations of the decision making by WHO became available recently. They are not very different from the previously released national evaluations, repeating the mantra of successful preparedness for the pandemic and small failures in the informing the uneducated public. But there are some details which makes these evaluations worth attention.
    The first one is “Recommendations for Good Practice in Pandemic Preparedness identified through evaluation of the response to pandemic (H1N1) 2009” produced for EuroWHO by Univershity of Nottingham[1]. It looks strange. After we were witnesses during last years of the extensive criticism of the nontransparent WHO decision making and the ignoring the conflict of interest (COI) of WHO experts it appears frivolous to publish the report without disclosure of the COI of the authors. But EuroWHO appointed the group and did hide the COI of the members. Quick check of three leading authors from University of Nottingham found that Jonathan Nguyen-Van-Tam has heavy connection to vaccine industry. The list of member states visited in relation to this evaluation report for the Europe appears strange (authors called it random): Armenia, Bosnia and Herzegovina, Denmark, Germany, Portugal, Switzerland, and Uzbekistan. Two countries of the European region – Ukraine where experience with vaccination was the most dramatic and Poland, where decision making was probably most successful are literally not mentioned in the report. Packed with deep-minded statements like “strong leadership and government engagement in conducting (preparedness is essential)” the report is totally about more money for buying vaccines and more attention for input from vaccine producers.
    The second report arrived from the European Parliament[2]. It is different from EuroWHO document. Prepared by Parliamentary committee it starts from the point that changing the definition of the pandemic “triggered a false alarm worldwide, with that alarmism giving rise to inappropriate public health decisions and a disproportionate response among the public and administrations of the European Union and its Member States”. Exaggerated costs had arisen to EU members are a consequence of the dependence from WHO with its blind faith in the flu vaccine. “The Member States … accepted this maximum-level (pandemic) alert, triggering a raft of measures that were costly, pointless and disproportionate to the actual – and known – severity of H1N1 influenza.” Report calls for building the independent and evidence based power of European Centre for Disease Prevention and Control (EuroCDC), for “immediate clarifications on the effectiveness of the influenza vaccination strategies recommended in the EU, given the weight of evidence casting doubt on their effectiveness”, more transparency and open COI of experts who advise the EU institutions.
    The European Parliament goes further. It adopted the resolution [3] saying: “Members express its approval for the introduction of a procedure enabling the Member States to make group purchases of anti-viral vaccines and medicinal products on a voluntary basis. They recall that … liability for the quality, safety and efficacy concerning the authorized indications of a medicinal product rests with the manufacturer. They call for full application of this rule by Member States in all contracts for the procurement of vaccines. The resolution urges the WHO to revise the definition of a pandemic, taking into consideration not only its geographical spread but also its severity… Parliament takes the view that the (EuroCDC) has to exercise its powers as an independent agency to assess and communicate the severity of infection risk and be given adequate means for all its tasks. The resolution underscores the need for studies independent of the pharmaceutical companies on vaccines and antiviral medications, including with regard to the monitoring of vaccination coverage. … it is necessary to ensure that scientific experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality. They request the development of a European code of conduct relating to the exercise of the function of a scientific expert in any European authority in charge of safety and of the management and anticipation of risks.”
    Worth to note that liberals and democrats in Euro parliament made a step ahead – they called for the verification of the COI statements of the parliamentary Committee on Environment, Public Health and Food Safety who drafted the report. Idea was rejected. Still the COI disclose is thought to be a subject of the independent verification in the science world. But to have at least the simple check of COI statements in the Euro parliament is not a crazy idea, especially in times of the mistrust.
    It is of interest to compare some of the statements in evaluations. Evaluation of the Norway decision making [4] say: “The first press conference, on April 27th, gave too much emphasis on an unrealistic worst case scenario, and this had repercussions on public opinion throughout the pandemic.” EuroCDC wrote to the WHO Pandemic and IHR Review Committee that “In Europe, a significant number of people perceived that public health authorities exaggerated the extent of the threat from H1N1, and that the response was out of proportion to the threat.”[5] Feel the difference? EuroCDC director is worrying not about the misleading statement, but that European people may lost the trust in the vaccination programs, when “investment in pandemic vaccines was the right thing to do in 2009” and “personally, I am most concerned about public confidence in vaccine programmes”[6]
    The third document is the External review of pandemic response released as a draft from the Review Committee on the Functioning of the International Health Regulations (IHR) and on Pandemic Influenza A (H1N1) 2009[7]. This review committee was announced by Director General M. Chan as an external, but from the beginning it became scandalous. Two members of the committee soon had to retire because, as WHO explained, they were members of the committee which made decisions under review. In reality these people were tainted heavily by COI and need to be excluded. Chaired by Harvey Fineberg, president of the Institute of Medicine in Washington, the Review Committee had to be independent. In fact, committee had its sittings in WHO and was managed by WHO. Anyway, H. Fineberg said that the group’s members are “authorized and indeed required to exercise independent judgment”, but recommendations made to WHO wouldn’t be binding[8]. The potential COI of the review committee members were nor disclosed.
    The draft report is critical on a small scale. Committee’s chairman at his September 2010 press-conference [8] said that critics of the WHO are “firmly held and grounded in an interpretation of a body of evidence that is highly selected and highly refined and this gets into the whole philosophy of the Cochrane approach which is legitimate but in my mind limited… it represents an outlier of the scientific view and it’s not a widely held position that that is the extreme position which is to say fundamentally don’t use antivirals and don’t use vaccine. The implication is because you haven’t proved that they work by RCTs. That’s the argument and there’re many RCTs and writers of RCTs of vaccines that would take different view of their results …” So, later the Review Committee kept itself in doubt that RCT is the best tool to evaluate the efficacy of the intervention, and decided not to cover the question of the vaccine efficacy but promoted the necessity of the vaccine’s purchases.
    Report binds together the scientific problems and problems of decision making by WHO: “WHO’s web site has described the prospect of severe disease in a possible pandemic, which was understandable in the context of expectations about H5N1. But the reality of H1N1 was quite different. Because H1N1 caused illness that did not require hospitalization in the vast majority of cases, the question of severity of the pandemic and how to characterize it became a key challenge. As the H1N1 virus spread to several countries within days, the possibility of rapid containment, a tenet of planning in WHO’s multi-stage response, was never really feasible.” The report celebrates the importance of IHR, and recommends to have the enforcement sanctions to the countries not obedient to WHO recommendations.
    The summary conclusion is that “WHO performed well in many ways during the pandemic, confronted systemic difficulties and demonstrated some shortcomings. The Committee found no evidence of malfeasance.” The possible misfeasance is not discussed, but shortcomings are found:
    “The absence of a consistent, measurable and understandable depiction of severity of the pandemic…
    Inadequately dispelling confusion about the definition of a pandemic. One online WHO document described pandemics as causing “enormous numbers of deaths and illness”, while the official definition of a pandemic was based only on the degree of spread…
    A pandemic phase structure that was needlessly complex. The multi-phase structure contains more stages than differentiated responses…
    Weekly requests for specific data were overwhelming to some countries… Country officials were not always convinced the data they submitted were being analysed and used…
    The decision to keep confidential the identities of Emergency Committee members… represented an understandable effort to protect the members from external pressures, this paradoxically fed suspicions that the Organization had something to hide…
    Lack of a sufficiently robust, systematic and open set of procedures for disclosing, recognizing and managing (COI) among expert advisers. In particular, potential COI among Emergency Committee (EC) members were not managed in a timely fashion by WHO. Five members of the EC and an Adviser to the Emergency Committee declared potential conflicts of interest. None of these were determined sufficiently important to merit the members’ exclusion from the EC. The relationships in question were published, along with the names of the members of the EC, when the pandemic was declared over on 10 August 2010. Before this information was published, however, assumptions about potential ties between EC members and industry led some to suspect wrongdoing. The Review Committee recognizes that WHO is taking steps to improve its management of COI…
    At a critical point of decision-making about the pandemic (moving from Phase 4 to 5), conferring with only a subset of the EC rather than inviting input from the full EC.
    The decision to diminish proactive communication with the media after declaring Phase 6 …was ill-advised.
    Failure to acknowledge legitimate reasons for some criticism, in particular, inconsistent descriptions of a pandemic, or the lack of timely disclosure of relationships potentially constituting a COI among experts who advised on plans and response to the pandemic. In such instances, WHO may have inadvertently contributed to confusion and suspicion…
    Despite the ultimate deployment of 78 million doses of pandemic influenza vaccine to 77 countries, numerous systemic difficulties impeded WHO’s ability to achieve a timely distribution of donated vaccines…
    Lack of a cohesive, overarching set of procedures and priorities for publishing consistent and timely technical guidance resulted in a multiplicity of technical units within the Organization individually generating an unmanageable number of documents.”
    Finally report clears WHO from accusations in any wrongdoing in relation to overstating of the severity of the epidemic as well as industry influence. “Some commentators accused WHO of rushing to announce Phase 6 and suggested the reason was to enrich vaccine manufacturers, some of whose advance-purchase agreements would be triggered by the declaration of Phase 6. Far from accelerating the declaration of Phase 6, WHO delayed declaration until evidence of sustained community spread in multiple regions of the world was undeniably occurring. As far as the Review Committee can determine, no critic of WHO has produced any direct evidence of commercial influence on decision-making. … In the Committee’s view, the inference by some critics that invisible commercial influences must account for WHO’s actions ignores the power of the core public health ethos to prevent disease and save lives.” The pathetic of the last phrase is notable, as well as the absence of any visible efforts of the Review Committee to clear the EC members. In September 2010 Review Committee chairman said that “We haven’t … yet looked at the individuals to answer the question: was this group (EC) well constituted if that’s what you mean, was it fairly constituted, was it correctly constituted: we have not yet done that.”[8] The final report shed no additional light on that.
    At the final session of the review committee [9] its chairman was asked about advanced purchases of vaccines and smart decision maing in Poland, where vaccines were not bought and swine flu incidence was the lowest. The answer was: “… there was great uncertainty as to how severe it would be, and that that uncertainty persisted through the time when purchase decisions had to be made… Now, it’s a little bit like saying; whether fire insurance was a good idea for your house. If you look back over the last year and your house did not burn down, do you then say, I was a fool for purchasing insurance?” This answer is completely ignoring the cost of the insurance. Answering to questions about possible decisions made for profits of the vaccine industry H. Fineberg repeated his statement that no proofs of malfeasance at WHO were found and that the ethos of public health is to prevent the life loss.
    I would say that it is an ethos of science and medicine as well as public health, which dictates the necessity of the open and straightforward criticism of the public organization, which makes decisions based on inappropriate criteria, in consultations with inappropriate people, and in a non-transparent fashion. If this critical lesson will not be learnt, we are destined to go to the other round of the scare and fear – this time by H2N2 virus and so on.
    References
    1. Jean-Gilles L, Hegermann-Lindencrone M, Brown CS, Hashim A, Shaw I, Nguyen-Van-Tam J. Recommendations for good practice in pandemic preparedness identified through evaluation of the response to pandemic (H1N1). University of Nottingham/WHO regional office for Europe 2009
    2. Draft report on the management of H1N1 influenza in 2009-2010 in the EU (2010/2153(INI)). European Parliament. Committee on the environment, public health and food safety. http://www.europarl.europa.eu/meetdocs/2009_2014/documents/envi/pr/835/835437/835437en.pdf (accessed 28 March, 2011).
    3. Evaluation of the management of H1N1 influenza in 2009-2010 in the EU. Ref. INI/2010/2153. http://www.europarl.europa.eu/oeil/FindByProcnum.do?lang=en&procnum=INI/2010/2153. (accessed 28 March, 2011).
    4. Directorate for civil protection and emergency preparedness: New influenza A(H1N1) 2009 – a review of the experiences in Norway. http://www.dsbinfo.no/DSBno/2010/Rapport/Pandemirapport/ (accessed 28 March, 2011).
    5. EuroCDC Written Evidence to WHO Pandemic and IHR Review Committee Meeting in Geneva, 28 September 2010 http://ecdc.europa.eu/en/press/news/Documents/20101004_Fineberg_written_evidence_pandemic.pdf (accessed 28 March, 2011)
    6. Sprenger M. Lessons learned from the 2010 pandemic. Oral evidence of ECDC director to Fineberg Committee, Geneva, 28 September 2010. http://ecdc.europa.eu/en/aboutus/organisation/Director%20Speeches/1009_Fineberg.pdf (accessed 28 March, 2011)
    7. Report of the Review Committee on the Functioning of the International Health Regulations (2005) and on Pandemic Influenza A (H1N1) 2009 Draft for discussion at the meeting of the Review Committee, 28 March 2011 http://www.who.int/ihr/preview_report_review_committee_mar2011_en.pdf (accessed 28 March, 2011)
    8. Transcript of press briefing with Dr H. Fineberg, Chair, International Health Regulations Review Committee
    29 September 201, held in WHO, Geneva.
    http://www.who.int/mediacentre/multimedia/pc_transcript_30_september_10_fineberg.pdf (accessed 28 March, 2011)
    9. Transcript of press briefing with Dr H. Fineberg, Chair, International Health Regulations Review Committee 28 March 2011. http://www.who.int/mediacentre/multimedia/pb_transcript_fineberg_20110328.pdf (accessed 5 April, 2011)

  2. Ronald A. Rader on May 23, 2011 at 8:40 am

    Yes, in hindsight, a lot of money was wasted on purchasing “pandemic” vaccines and drugs. But in many respects, considering the global nature of the threat, the response amounts spent could be considered inadequate (if there had been a real pandemic that year).

    With the threat seeming real and the course of the epidemic unpredictable at the time, one could just as well now call for investigations of inadequate preparation, including vaccine/drug spending, in case we (the world) had not lucked-out in 2009. If there had been a real pandemic, e.g., one with say just >10% mortality and just 20-40% of the world’s population infected (less severe than 1918 pandemic), there would now be accusations and investigations of inadequate spending, including on vaccines and drugs, with these political decisions perhaps now even considered crimes against humanity.

    So, from my perspective, it’s OK/good to investigate the vaccine/drug purchase decision-related processes, but there should be balance and consideration that things could have gone much worse and that the purchasing decisions made could well have been very inadequate (millions, 10s or 100s of millions could have died). For example, the U.S. and some other countries had enough vaccines and drugs to largely take care of their own populations, but the majority of countries and the world population had no such protection. So, any investigations should also consider, in this context, why was there such relatively wimpy/cheap/inadequate preparation and response by most countries?; what if 2009 had turned out to be a mild-medium genuine pandemic – where would the purchase decisions that were made have been wrong, inadequate, etc.? Is pandemic vaccine/drug spending like purchasing insurance, and was inadequate insurance purchased in 2009?

    Ronald A. Rader
    Former Editor, Antiviral Agents Bulletin (for 15 years, 1987-2003, the only periodical specializing in antiviral drug and vaccine development)

    • GoozNews on May 23, 2011 at 9:13 am

      That’s why it’s so important to have people without ties to vaccine or drug manufacturers making these decisions. Every borderline decision will be called into question when the people making those decisions have conflicts. In this case, detailed reviews by European authorities (see Dr. Vlassov’s long foot-noted article in this comments section) would appear to call your conclusions into question.

  3. Henry Lin MD on May 23, 2011 at 1:18 pm

    The availability of the H1N1 vaccine was too late. My previously healthy son,
    Trevor Ron Lin, died before the vaccine was available in our area.
    His sister and I became extremely ill & I was hospitalized as
    a previously fit active duty military serviceman. His mom
    & brother received oseltamivir & only had a mild illness.
    Do not let your statistics let you forget that each patient
    is important. We physicians should not fall into the trap that an
    “occasional” mortality is part of life.
    My son was denied Tamiflu by my ER colleagues since “statistically speaking,” that drug would not have made a difference. Trevor & I disagree. Do you?

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