A / H1N1: A pandemic bought by Roche and GlaxoSmithKline

A / H1N1: A pandemic bought by Roche and GlaxoSmithKline

Probably many of you know about the fake A / H1N1 flu pandemic. We at Corvelva talked about it in the article “Avian: An invented pandemic"But we had focused mainly on the drug Tamiflu and, of course, the manufacturer La Roche regarding the "pandemic of 2006, avian. Let's talk about the usual story, trit and retract, drug approved without studies, money, politics and regulatory bodies at least superficial.

Today we took the trouble to read all the documentation from the joint investigation of the British Medical Journal and Bureau of Investigative Journalism and we decided to write a new article entitled "A / H1N1: A pandemic bought by Roche and GlaxoSmithKline" slightly correcting the pull compared to the previous article.

As we said, the British Medical Journal and the Bureau of Investigative Journalism in June 2010 published this survey which raised particularly alarming facts. Leading scientists who advised the World Health Organization to plan a flu pandemic had done paid work for the pharmaceutical companies that were making money from the guide they were preparing. These conflicts of interest have never been publicly disclosed by WHO and WHO has filed investigations into its management of the A / H1N1 pandemic as "conspiracy theories".

It all started on June 11, 2009, when Dr. Margaret Chan, director general of the World Health Organization, made this statement:

"I conferred with the main flu experts, virologists and public health officials, in line with the procedures established in the International Health Regulations. I have asked for advice and assistance from an emergency committee set up for this purpose: based on the available evidence and on These expert assessments met the scientific criteria for a flu pandemic ... The world is now at the start of the 2009 flu pandemic. "

The BMJ / The Bureau survey reveals a system that struggles to manage the intrinsic conflict between the pharmaceutical industry, WHO and the global public health system, where everyone draws on the same pool of scientific experts. This investigation unearthed evidence that raises disturbing questions about how WHO managed conflicts of interest among scientists who recommended pandemic planning and the transparency of the science behind its advice to governments.

  • Was it appropriate for the WHO to get advice from experts who had stated financial and research ties to pharmaceutical companies that produced antivirals and flu vaccines?
  • Why was the important WHO guide drafted by an influenza expert who received payment for other jobs from Roche, manufacturers of Oseltamivir and GlaxoSmithKline, manufacturers of Zanamivir?
  • Why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those inside the WHO?

The only comment to the questions posed by the survey, by Dr Margaret Chan, director general of the World Health Organization, was "Conspiracies".


The beginnings

The avenues for criticism from the Council of Europe can be traced back to 1999, a crucial year in the world of flu. In April of that year, WHO, stimulated by the outbreak ofbird flu in 1997 in Hong Kong, began to organize for a feared pandemic. It has developed a key document, Pandemic influenza plan: the role of the WHO and guidelines for national and regional planning.

The first WHO pandemic influenza preparedness plan was clear on the risk scale that the world faced in 1999:

"It is impossible to predict when a pandemic could occur. A true influenza pandemic virus should have appeared that behaved as in 1918, even taking into account medical advances since then, unprecedented costs of illness and death would be expected"

R Snacken, J Wood, LR Haaheim, AP Kendal, GJ Ligthart and D Lavanchy participated in the drafting of this first document, in collaboration with the European Scientific Working Group on Influenza (ESWI). What this document does not reveal is that ESWI is funded entirely by Roche and other flu drug manufacturers, nor that René Snacken and Daniel Lavanchy participated in Roche sponsored events the previous year.

Dr Snacken worked for the Belgian ministry of public health when he wrote of studies regarding neuraminidase inhibitors for a Roche promotional booklet. And Dr. Lavanchy, meanwhile, despite being a WHO employee when he appeared in a Roche-sponsored symposium in 1998. His role at the time was in the WHO division of viral diseases.

In 1999 other members joined the European scientific working group on influenza, including Professor Karl Nicholson of Leicester University (United Kingdom) and Professor Abe Osterhaus of the Erasmus University in the Netherlands. These two scientists appear in Roche's marketing materials between 1998 and 2000. Both experts were also involved in a Roche-funded study of oseltamivir. It remains one of the main studies supporting the efficacy of oseltamivir and also a proven study that used pharmaceutical and undeclared funded ghostwriters.

The influence of the European scientific working group on influenza would continue for 10 years and requests for pandemic planning became more stringent. Founded in 1992, this multidisciplinary group of key influenza opinion leaders aims to combat epidemic and pandemic influenza and claims links with the WHO, the Robert Koch Institute and the European Center for Disease Prevention and Control. Despite its claims of scientific independence, its funding is 100% industrial and presents a potential conflict of interest. One if its role is to put pressure on politicians, as highlighted in a 2009 policy document.

The group's political plan, for the period 2006-2010, explicitly specified that government representatives had to "take measures to encourage the pharmaceutical industry to plan vaccine / antiviral production capacity in advance" and also "encourage and support research and development of the pandemic vaccine" e "develop a policy for antiviral storage".

Barbara Mintzes, professor in the Department of Pharmacology and Therapy at the University of British Columbia, is currently part of a team working with Health Action International and WHO to develop model curricula for medical and pharmaceutical students on drug promotion and interactions with industry, including conflict of interest. Do you think caution is advised when working with medical bodies of this type. He said the group provided "well-founded information, acceptable information"; and also "networking / exchange with other stakeholders (for example, with the industry in order to establish pandemic vaccination and antiviral contracts)"Meanwhile, in Roche's marketing plan, it appeared as a goal "align Roche with credible third-party supporters".

In 1999 two new drugs came onto the market: oseltamivir from Roche; and zanamivir produced by what is now GlaxoSmithKline. And again in 1999 Professor Osterhaus published an article proposing the use of neuraminidase inhibitors in pandemics: "Finally, during a possible future influenza pandemic, given their wide reactivity towards the influenza virus neuraminidase subtypes and the expected lack of sufficient quantities of vaccine, the new antivirals will undoubtedly have an essential role to play in reducing the number of the victims ". However, he stated in the study that antivirals should not be seen as a substitute for vaccinations. "A close collaboration and consultation between, on the one hand, the companies that market flu vaccines and, on the other, those marketing antivirals will therefore be absolutely essential: it is important that a clear and uniform message is delivered indicating the complementary roles of the vaccines and antivirals ". Practically a preparatory promotion to oseltamivir and zanamivir.


Food and Drug Administration

While the excitement of these drugs fueled scientific symposia, the American Food and Drug Administration (FDA) was not entirely convinced. Since then the BMJ / Bureau has spoken to people from American and European pharmaceutical regulators, the FDA and the European Medicines Agency (EMEA), who said that both regulators have struggled with the scarcity of data presented for zanamivir. and oseltamivir during the licensing process.

In the United States, the FDA first approved zanamivir in 1999. Michael Elashoff, a former FDA employee, was the statistician who worked on zanamivir. He told BMJ how the FDA's advisory board initially rejected zanamivir because the drug lacked efficacy.

After Dr Elashoff's review (which had access to individual patient data and summary study reports) the FDA advisory committee voted not to approve zanamivir based on the fact that it was no more effective than placebo. His statements were:

"When I was reviewing the data, I tried to replicate the analyzes in their summary study reports. The problem was not the quality of the data, but the sensitivity analyzes showed even less effectiveness ... The safety analysis showed that there were problems, but the focus was on whether Glaxo had proven effective. "

There were flu experts on the FDA advisory board, and much of the discussion depended on the fact that a drug that looked so promising in previous studies was not working in larger studies in the United States. One hypothesis was that people in the United States were taking other drugs. factor that masked any effect of zanamivir. So zanamivir may have no effect on symptoms other than the basic medications people take when they have flu.

However, the FDA management decided to reverse the committee's recommendation and when Dr. Elashoff started working on the review of oseltamivir, the FDA management reassigned the oseltamivir review to someone else.


European Medicines Agency

In Europe, the EMEA was equally disturbed by the tests of oseltamivir. In early 2002, Roche applied for a European license to the EMEA and it was a lengthy process, with three meetings of the Committee for Medicinal Products for Human Use and the Expert Groups. Echoing the results of Cochrane Collaborations in 2009, Pekka Kurki, of the Finnish Medicines Agency, declared on oseltamivir:

"We discussed the same issues that are still discussed today: does it show clinically significant benefits in the treatment and prophylaxis of influenza and what was the extent of the benefits presented in the RCTs? Cochranes in 2009 are very similar in terms of the size of the effect in RCTs. The data show that the effects of Tamiflu were clear but not very impressive ... What was not clear and is not yet clear is the impact of Tamiflu on serious complications. Circulatory influence was very mild when Tamiflu was developed and therefore it is very difficult to say something about serious complications. The data did not clearly show an effect on serious complications - it was not demonstrated by RCTs. "

In documents obtained under the freedom of information legislation, two of the experts who provided opinions during the EMEA licensing process also participated in the production of Roche's marketing materials: Annike Linde and Rene Snacken. In the EMEA presentation of dr. Snacken of February 18, 2002, discussed the need for chemoprophylaxis and asked for the use of oseltamivir during a pandemic. He made his presentation as a representative of the Belgian Ministry of Public Health. At the time, dr. Snacken was also a "liaison officer" for the European scientific working group on influenza.

Dr Linde, now a Swedish state epidemiologist, told BMJ / Bureau that she had received payments from Roche International for the various jobs she had been doing for the company until 2002. She later gave occasional lessons for Roche Sweden. All the money he received from Roche was given, says dr. Linde, at the Swedish Institute for Infectious Disease Control.


Develop guidelines

In October 2002, WHO convened a flu meeting at its headquarters in Geneva. Their aim was to develop WHO guidelines for the use of vaccines and antivirals during a flu pandemic.
This meeting was attended by representatives of Roche and Aventis Pasteur and three experts who lent their name to the marketing materials of oseltamivir (professors Karl Nicholson, Ab Osterhaus and Fred Hayden).

Two years later, WHO published a key report of that meeting, WHO guidelines on the use of vaccines and antivirals during 2004 flu pandemics. The specific guide on antivirals was written by Fred Hayden. Professor Hayden was paid by Roche for lessons and consultancy work for the company at the time the guide was produced and published. He also received payments from GlaxoSmithKline for consultancy and conferences until 2002.

The BMJ / Bureau survey also identified relevant and disclosable interests related to the other two authors of annexes to the 2004 WHO guidelines. Arnold Monto deals with the use of vaccines in pandemics. Between 2000 and 2004 - and at the time of writing the annex - dr. Monto has declared fees, consultancy fees and research support from Roche, consultancy fees and research support from GlaxoSmithKline and also seeks funding from ViroPharma. No conflict of interest statements were included in the annex he wrote for the WHO.

Professor Karl Nicholson is the author of the third attachment, Pandemic Influenza, according to the statements made by Professor Nicholson in the BMJ16 and Lancet in 2003, he had received travel and honor sponsorships from GlaxoSmithKline and Roche for consultations and interventions in international disease symposia respiratory and infectious. No declaration of conflict of interest was included in the annex he wrote for the WHO.

 Leaving aside the question of what statements the experts made to WHO, it remains a simple fact: WHO itself did not publicly disclose any of these conflicts of interest when it published the 2004 guidelines. It is not known whether the information about these conflicts of interest were privately disclosed to governments around the world when they were considering the advice contained in the guidelines.

At present, this situation is the worst possible outcome for the WHO, according to Professor Chris Del Mar, author of Cochrane Review and expert of the WHO strategic immunization group expert. We recall one of his statements:

"If it is shown that the authors of the WHO guidelines promoting the use of certain medicines were being paid at the same time by the manufacturers of those medicines for other jobs they were doing for those companies, they are reprehensible and should be sentenced in i strongest possible terms "


Emergency committee

These apparent inconsistencies in the WHO approach to transparency and conflict of interest management extend to the work of the Emergency Committee formed to advise the WHO Director-General on the pandemic. The identities of its 16 members are unknown outside the WHO. Since then, this secret committee has led the WHO pandemic policy, including deciding when to judge that the pandemic is over.

WHO says it must keep identities secret to protect scientists from being influenced or targeted by industry. In a call to the BMJ / The Bureau in March 2010, WHO spokesman Gregory Hartl explained: "Our general principle is that we want to protect the committee from external influences".

The committee recommended phase changes and temporary recommendations to the WHO Director-General. According to WHO, when the Emergency Committee met to discuss a possible switch to a pandemic declaration, the meeting also included members representing Australia, Canada, Chile, Japan, Mexico, Spain, the United Kingdom and the United States. . These national representatives were present to ensure full consideration of the views and possible reservations of the countries which should bear the initial weight of the economic and social repercussions.

WHO says that all members of the Emergency Committee sign a confidentiality agreement, provide a declaration of interest and agree to give their consultation time freely, without compensation. However, only one member of the committee has been publicly named: Professor John MacKenzie, who chairs him.

This is a worrying position: it suggests that WHO consider other advisory groups whose members are not anonymous - such as the strategic advisory group of experts on immunization - to be potentially subject to external influences, and does not allow to check the scientists selected for advise WHO and global governments on a major public health emergency.

The committee's secrecy has fueled conspiracy theories, in particular the activation of pandemic vaccination contracts outstanding. A key question is whether pharmaceutical companies, which had invested around $ 4 billion in the development of the swine flu vaccine, had supporters on the emergency committee, who then put pressure on the WHO to declare a pandemic.

The BMJ / The Bureau confirmed that dr. Monto, dr. John Wood and dr. Masato Tashiro are members of the emergency committee. Last year, according to figures released by GlaxoSmithKline in the United States, Professor Monto received $ 3000 from the company in the period between the second quarter and the last quarter of 2009. Dr. John Wood works for the British National Institute for Biological Standards and Control (NIBSC). Dr Wood, like dr. Tashiro has no conflicts of personal interest, but told BMJ / The Bureau that as part of their statutory role in developing standards for measuring biological drugs, to ensure accurate dosing and independent control testing, to ensure their safety and efficacy, the institute must work closely with the pharmaceutical industry.


Moral

Private companies, Roche and GlaxoSmithKline, funded most of the experts who had to advise WHO on drafting guidelines for pandemics. The result has been at least two pandemics, one invented in 2006 and one purchased in 2009. WHO has advised / imposed on many states the purchase of antiviral drugs and vaccines with the result of guaranteeing huge profits for two companies, Roche and GlaxoSmithKline. . The various states have found themselves with huge reserves of unused vaccines and antivirals. No pandemic.


References

  1. https://www.bmj.com/content/340/bmj.c2912
  2. Cohen D. Complications: tracking down the data on oseltamivir. BMJ 2009; 339: b [Free Full Text] 

  3. Doshi P. Calibrated response to emerging infections. BMJ 2009; 339: b [Free Full Text] 

  4. Nicholson KG, Aoki FY, Osterhaus AD, Trottier S, Carewicz O, Mercier CH, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomized controlled trial. Lancet 2000; 355: 1845-50. [CrossRef] [Web of Science] [Medline] 

  5. European Scientific Working Group on Influenza. About ESWI. www.eswi.org/who-are-we/about-eswi. 

  6. European Scientific Working Group on Influenza. Revised policy plan 2006-2010. www.eswi.org/userfiles/files/ESWI%20policy%20plan%202006-2010.doc. 

  7. Holmes Report. Tamiflu launch media campaign. www.holmesreport.com/story.cfm?edit_id=71&typeid=4. 

  8. Osterhaus A, de Jong J. Prophylactic role. www.eswi.org/modulefiles/publications/pdfs/no-10-december-1998.pdf. 

  9. 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; 339: b [Abstract / Free Full Text] 

  10. US Food and Drug Administration. FDA approved drugs for influenza. www.fda.gov/drugs/drugsafety/informationbydrugclass/ucmhtm#ApprovedDrugs. 

  11. Monto AS, Gravenstein S, Elliott M, Colopy M, Schweinle J. Clinical signs and symptoms predicting influenza infection. ArchInternal With 2000; 160: 3243-7 [Abstract / Free Full Text] 

  12. Monto AS, Rotthoff J, Teich E, Herlocher ML, Truscon R, Yen HL, et al. Detection and control of influenza outbreaks in well-vaccinated nursing home populations. wink infected Dis 2004; 39: 459-64. [CrossRef] [Web of Science] [Medline] 

  13. Herlocher ML, Truscon R, Elias S, Yen HL, Roberts NA, Ohmit SE, et al. Influenza viruses resistant to the antiviral drug oseltamivir: transmission studies in ferrets. J infected Dis 2004; 190: 1627-30. [CrossRef] [Web of Science] [Medline] 

  14. Monto AS, Pichichero ME, Blanckenberg SJ, Ruuskanen O, Cooper C, Fleming DM, et al. Zanamivir prophylaxis: an effective strategy for the prevention of influenza types A and B within households. J infected Dis 2002; 186: 1582-8. [CrossRef] [Web of Science] [Medline] 

  15. Herlocher ML, Truscon R, Fenton R, Klimov A, Elias S, Ohmit SE, et al. Assessment of development of resistance to antivirals in the ferret model of influenza virus infection. J infected Dis 2003; 188: 1355-61 [CrossRef] [Web of Science] [Medline] 

  16. Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Internal With 2003; 163: 487-94. [Abstract / Free Full Text] 

  17. Cooper NJ, Sutton AJ, Abrams KR, Wailoo A, Turner D, Nicholson KG. Effectiveness of neuraminidase inhibitors in treatment and prevention of influenza A and B: systematic review and meta-analyzes of randomized controlled trials. BMJ 2003; 326: 1235. [Abstract / Free Full Text] 

  18. Nicholson KG, Wood JM, Zambon M. Influenza. Lancet 2003; 362: 1733-45. [CrossRef] [Web of Science] [Medline] 

  19. World Health Organization. Guidelines for WHO guidelines. World Health Organization, 2003. 

  20. National Academies. Policy and procedures on committee composition and balance and conflicts of interest for committees used in the development of reports. www.nationalacademies.org/coi/index.html. 

  21. Infectious Disease Society of America. Congratulations to the 2009 Society Award Recipients. www.idsociety.org/Content.aspx?id=15497. 

  22. International Federation of Pharmaceutical Manufacturers and Associations Influenza Vaccine Supply International Task Force. WHO influenza virus surveillance system and influenza vaccine production. 2008. www.ifpma.org/Influenza/content/pdfs/WHO_IGM/06_2008_WHO_Influenza_Virus_Surveillance_System.pdf. 

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