NZ flu expert linked to drug firms
In an expose in the 18 July 2010 issue of the Sunday Star Times Tony Wall describes how a leading virologist Dr Lance Jennings failed to disclose his ties to the drug companies who manufacture the anti-viral drugs Tamiflu and Relenza, and the H1N1 vaccine. The article can be accessed at:
www.stuff.co.nz/sunday-star-times/news/3929824/Flu-expert-linked-to-drug-firms
The WHO, H1N1 flu and the pharmaceutical industry
Questions are being raised at an international level about the World Health Organisation’s (WHO) handling of the H1N1 influenza pandemic. The issues relate to how the WHO managed the conflicts of interest among the scientists they engaged to advise them on their pandemic planning.
In a hard-hitting article that appeared in the British Medical Journal on 12 June 2010, an investigation by Deborah Cohen and Philip Carter reveals how key scientists advising the WHO on planning for an influenza pandemic had done paid work for pharmaceutical firms that stood to gain from the advice they gave. (1)
Stockpiles of flu drugs
This comes at a time when governments that took advice from WHO are counting the cost and unwinding their vaccine contracts as billions of dollars’ worth of stockpiled oseltamivir (Tamiflu) and zanamivir (Relenza) lie unused in warehouses round the world. Poland was one country that declined to join the panic buying of vaccines and antivirals triggered when WHO declared the pandemic. However, others like the UK and France are currently selling unused vaccine to other countries and sitting on huge stockpiles of unused Tamiflu.
Following allegations of industry influence, there have been an unprecedented number of reviews and inquiries, including the Council of Europe, European Parliament and even the WHO itself. At the beginning of June the results of an inquiry undertaken for the Council of Europe Parliamentary Assembly was published. The report was critical of the decision-making around the H1N1 influenza crisis pointing to its lack of transparency. The composition of the WHO’s emergency committee remains a secret known only to those within WHO. WHO has refused to supply any details on the key scientists involved, whether their conflicts of interest were declared and how they were managed.
Waste of health dollars
The report prepared for the Council of Europe “pointed to distortion of priorities of public health services, a waste of huge sums of public money, provocation of unjustified fear, and the creation of health risks through vaccines and medications which might not have been sufficiently tested before being authorised in fast-track procedures.” (1)
Communicating uncertainty
In commenting on the difficulty of communicating the concept and uncertainty of risk in a pandemic situation, one world expert said: “The problem is not so much that communication uncertainty is difficult, but that uncertainty was not communicated. There was no scientific basis for the WHO’s estimate of 2 billion for likely H1N1 cases, and we knew little about the benefits and harms of the vaccination. The WHO maintained this 2 billion estimate even after the winter season in Australia and New Zealand showed that only about one to two out of 1000 people were infected. Last but not least, it changed the very definition of a pandemic.”
Definition of pandemic changed
For years WHO has defined pandemics as outbreaks causing “enormous numbers of deaths and illness” but in May 2009 this phrase was removed from the definition. The WHO also dropped the requirement for a new subtype, meaning that many seasonal flu viruses could be classified as pandemic influenza. (2)
Tamiflu and Relenza
In 1999 two new drugs came onto the market. Tamiflu, manufactured by Roche, and Relenza, manufactured by GlaxoSmithKline, were two antiviral medications that competed for sales globally over the following decade. However, the US Food and Drug Administration (FDA) was far from convinced of the efficacy of Relenza, and the European Medicines Agency (EMEA) struggled with the paucity of data presented to them for both drugs. Added to that was the Cochrane Collaboration’s findings that the effectiveness of the drugs were impossible to evaluate.
Flu drugs not very effective
Part of the problem regarding the lack of effectiveness of the drugs was that people with flu take other medications to manage their symptoms and little benefit from antivirals shows up in such situations. One statistician working for the FDA on evaluating Relenza stated that it was no more effective than a placebo and didn’t reduce symptoms even by a day.
In commenting on the studies on Tamiflu, Pekka Kurki of the Finnish Medicines Agency stated that while the effects of Tamiflu were clear they were not very impressive.
“What was unclear and is still unclear is what the impact of Tamiflu on serious complications. Circulating influenza was very mild when Tamiflu was developed and therefore it is very difficult to say anything about serious complications. The data did not clearly show an effect on serious complications – it was not demonstrated by the RCTs (randomised controlled trials).”
WHO Emergency Committee
In 2009 WHO formed an Emergency Committee to advise it on the H1N1 pandemic. The identities of the 16 committee members remain a secret with the exception of committee chairperson Professor John MacKenzie. The secrecy of the committee has fuelled conspiracy theories, particularly around the activation of dormant pandemic vaccine contracts. As the authors of the BMJ article note: “A key question is whether the pharmaceutical companies, which had invested around $4 billion in developing a vaccine, had supporters inside the emergency committee, who then put pressure on WHO to declare a pandemic. It was the declaring of the pandemic that triggered the contracts.”
Alongside the need for greater transparency and accountability in the decision-making processes there lies the need to count the cost of largely ineffective antiviral drugs and unnecessary vaccines. As epidemiologist Luc Bonneux and Professor Van Damme put it in a personal view published in the BMJ the week prior to the Cohen & Carter investigation:
“The decisions to stockpile antivirals and influenza vaccine to control avian flu (2005-6) and swine flu (2009) cost large amounts of money. Both epidemic threats were mostly iatrogenic pandemics of panic, which caused little human suffering, but the global plans to control them were largely a waste of money…
The core of health economics and health policy is that resources are scarce. If resources were infinite, all possible measures could be taken to fight disease, including prevention of all hypothetical possibilities. Because resources are limited, wise allocation saves lives. Money spent in stockpiling antivirals with hypothetical effectiveness against a hypothetical pandemic is not available for health care, or for education, or for any other important human need thought to be underfunded.” (3)
References
(1) Deborah Cohen and Philip Carter. “WHO and the pandemic flu conspir-acies.” BMJ 12 June 2010.
(2) Ron Law. “WHO and pandemic flu: There was also no subtype.” BMJ 29 June 2010.
(3) Luc Bonneux and Wim Van Damme. “Preventing iatrogenic pandemics of panic. Do it in a NICE way.” BMJ 9 June 2010.
AWHC Newsletter July 2010
The H1N1 Vaccine & Children
Despite predictions of an early return of Influenza A (H1N1) flu, as autumn fades into winter, New Zealand has yet to see the start of its seasonal flu season.
As reported in the March 2010 issue of the AWHC newsletter, the Ministry of Health embarked on an influenza campaign in February 2010 which saw a roll out of first the H1N1 (swine) flu vaccine, followed by the trivalent influenza vaccine that this year aims to protect against the H1N1 virus, as well as the Influenza A (H3N2) virus and the Influenza B/Brisbane virus.
Unlike flu vaccination campaigns in previous years, the MOH is especially targeting pregnant women, as well as children who are deemed to be in the at risk group. This includes Maori and Pacific children, children with chronic conditions including neurological conditions and respiratory conditions, eg asthma, as well as those who live in very poor areas.
Having recently upgraded the numbers of those who died in last years H1N1 flu epidemic from 20 to 35 (1), the Ministry is now rolling out a vaccination campaign without having produced information for pregnant women faced with deciding whether to have the vaccine, or for parents who are wondering whether to get their young children vaccinated.
The lack of information has been exacerbated by the reports from Australia of the death of a toddler from a febrile convulsion that occurred after the administration of the flu vaccine, and the hospitalisations of hundreds of other children who experienced a very high fever and convulsions.
As a result of the unexpectedly high incidence of febrile convulsions in young children Australia has decided to suspend its vaccination programme for all children under 5 years while they further consider their data. (2)
Some facts about these vaccines
New Zealand has now used up its stocks of FluVax, the flu vaccine linked to the incidence of high fever and convulsions in young children both here and in Australia. (3)(4)
There is, however, no clinical data to support or refute the theory that FluVax causes more severe reactions than any of the other flu vaccines currently in use. (4) In fact there is unlikely to be any difference between FluVax and the other two flu vaccines currently in use in NZ – Vaxigrip and InfluVac – as all three vaccines were manufactured to produce immunity to the same three strains of influenza. (3)
Fever is a known side effect of the influenza vaccine. It is particularly common in children under 3 years of age who are given the flu vaccine and can lead to febrile convulsions. (5)
Other common side effects of the flu vaccine include headache, inflammation of the nose, dizziness, vertigo, joint pain, muscle pain, sore throat, sweating, fever, chills, fatigue and malaise – similar to those of the flu. (6)
The studies that were published by CSL, the manufacturer of FluVax, earlier this year revealed that a third of children who received the lower dose of the vaccine developed a high fever and in about 15% of these children it was over 38.5 degrees. There were other side effects as well such as vomiting and malaise. (7)
People/children who have an allergy to eggs or egg protein should not have the flu vaccine as the vaccine virus is grown in hen’s eggs. (8)
It takes about two weeks to develop antibodies to the flu viruses in the seasonal flu vaccine after being vaccinated. (9)
Seasonal flu vaccines are only about 50% effective when given to an entire population. (7) For healthy adults under the age of 65 years the flu vaccine is about 80% effective. However, in people over the age of 65 years and in children the flu vaccine is relatively ineffective. (9) The flu vaccine is nowhere as near as good as any of the other vaccines in use (7) which means many of those who have been vaccinated may still get the flu.
Poor data
Internationally there is extremely poor data on the impact of the flu vaccine on children, particularly very young children. Professor Peter Collingnon, an infectious diseases physician and microbiologist in Australia, recommended that prospectively collected data on large numbers of people be collected, so parents can make an informed decision on whether to get their child vaccinated with the flu vaccine. (7)
Speaking on National Radio at the end of April, Professor Collingnon said he was very surprised that when it became apparent very early on that the mortality rate for H1N1/swine flu for the vast majority of people was much lower than ordinary seasonal influenza, health authorities around the world did not change their plans.
Given that a healthy adult under the age of 30 with no risk factors like heart or lung disease had less than a one in a million chance of dying from swine flu, it did not make sense to continue with plans to urgently manufacture a vaccine and then proceed to vaccinate whole populations. He is particularly concerned at the lack of data there is on seasonal flu vaccines, and suggested that before a new flu vaccine is rolled out to millions of people a pilot should be set up with around 20 GP practices with practice nurses. All those who get injected with the latest flu vaccine could be given a card to fill in, or in the case of children for their parents to fill in, and they are all followed up for a week or two. This would enable health authorities to obtain good information in a timely fashion on the first 5,000 to 10,000 people vaccinated with the latest flu vaccine, he said. (7)
It would also enable parents faced with difficult decisions around having the vaccine themselves or having their children vaccinated to make an informed choice.
References:
1.www.surv.esr.cri.nz/PDF_surveillance/Virology/FluWeekRpt/2010/FluWeekRpt201017.pdf 2.www.moh.govt.nz/moh.nsf/pagesmh/9164/$File/gp-fluvax-fax-apr2010.doc
3.Nikki Turner on National Radio’s Nine to Noon programme on 28 April 2010 – www.radionz.co.nz/national/programmes/ninetonoon/20100428
4.www.moh.govt.nz/moh.nsf/pagesmh/9164/$File/gp-fluvax-fax-apr2010.doc
5.www.immune.org.nz/site_resources/Professionals/Health_professional_notes_on_flu_vaccine_and_febrile_convulsions.pdf 6. “Early Protection Programme Information Pack.” Ministry of Health. January 2010.
7. Prof. Peter Collingnon on National Radio’s Nine to Noon programme on 28 April 2010 – www.radionz.co.nz/national/programmes/ninetonoon/20100428
8.www.influenza.org.nz/site_resources/Influenza/Influenza%202010/NISG_FLUKIT.pdf
9.www.moh.govt.nz/moh.nsf/indexmh/influenza-a-h1n1-2010-faqsseasonal
May 2010
Adverse reactions to the H1N1 Vaccine in Children
For a very informative interview with Professor Peter Collingnon from Western Australia on the adverse reactions – high fever, convulsions, and the death of one young child in Australia – to the H1N1 vaccine in children go to:
http://www.radionz.co.nz/national/programmes/ninetonoon/20100428
“Influenza vaccination: Policy vs evidence”
Public health analysis on the evidence for influenza vaccinations that appeared in the British Medical Journal in 2006 –
http://www.bmj.com/cgi/content/full/333/7574/912
H1N1 – SOME HISTORY & SOME CHOICES
Every year the onset of the colder temperatures of autumn and winter is accompanied by the appearance of the latest influenza virus. And every year about a million people around the world die as a result of getting infected. (1) The figure could actually be higher than this because neither China nor India reports flu statistics to the World Health Organisation (WHO). None of this makes the news let alone hits the headlines.
But in 2009 the first flu virus happened to be a kind of rerun of the first wave of the famous flu epidemic of 1918 – otherwise known as H1N1, one of many varieties of Influenza A. The 1918 flu was called the “Spanish flu,” because newspapers in neutral Spain were uncensored and were thus the first to report its arrival. Elsewhere in the western world, governments and their health systems conspired to reassure and mislead the public about the true nature of the disease. (2)
Humans to pigs
Given that this latest version of the 1918 flu virus first surfaced in Mexico the world dallied briefly with calling it the Mexican flu, but the Mexicans weren’t going to be lumbered with being blamed for the latest outbreak of Influenza A, and protested furiously. So it got stuck with being called swine flu because it was initially thought to have been picked up by humans from pigs. However medical research tells us it is far more likely to have been the other way round. It is also worth noting here that it is now believed that pigs caught the 1918 Spanish flu from humans. (3)
Following the 1968 flu epidemic (an H3N2 subtype) researchers discovered that influenza’s natural home is in ducks and waterfowl, not pigs. It is now known that at least three or four of the Influenza A epidemics to circle the globe in the last 110 years originated in the Guangdong region of southern China where huge numbers of pigs, domestic ducks and chickens and wild waterfowl live in traditional ecological intimacy.
Following the outbreak of the Hong Kong flu in 1997 (an H5N1 subtype) researchers began carefully isolating viruses from ducks in the live-poultry markets of the Guangdong city of Shantou. What they discovered overturned previously held beliefs about the evolution of influenza. (1)
Ducks to chickens and back again
As well as discovering a totally unexpected genetic diversity of almost 500 distinct strains of influenza, they found undeniable evidence that viruses were evolving from ducks to poultry and back again. The significance of the Shantou research was that it revealed that several sub-types of the influenza virus were travelling rapidly on the path towards a potential worldwide pandemic. (1)
However, there is a great deal more to this story than ducks and other waterfowl and their migrations. Ducks have evolved to live quite happily with their multiple avian flu viruses. It is what we humans have done that provides the shock horror elements of this story. Deforestation, agribusiness, the fast food industries, burgeoning mega slums, the behaviour of the pharmaceutical industry, and corrupt governments have all played a large part in creating the ecological conditions for what is about to happen. And there can be no doubt that there will be what some scientists have referred to as a viral apocalypse; it is just a matter of time.
Over-reacting?
It is in part this knowledge that lies behind the extraordinary measures that the Ministry of Health took in May, June and July 2009 following the latest outbreak of the H1N1 flu virus. While quarantining possible cases, closing schools, and offering expensive antiviral medication (the stocks of Tamiflu needed using up anyway as it was about to hit its use by date), served to delay its rapid spread throughout the country, health authorities were acutely aware that they didn’t know what was going to happen next.
In 1918 a second wave of infection followed that was far deadlier than the first. While the geographical origin of H1N1 is still not known (a Kansas army base, the trenches in France, and southern China are all proposed epicentres), in total it has been estimated that the 1918 flu pandemic resulted in the deaths of 50 to 100 million people worldwide. Some experts think the figure was much higher than this. Between 2 – 5% of the world’s population died.
The virus exacted most of its victims from those who were already compromised by war, famine, and diseases including cholera and malaria. Iran suffered the greatest relative mortality with the death of between 8 – 22% of its population. It has been calculated that around 20 million people died in India alone. (4)
Real immunity
It is now known that those who caught the initial mild strain of the first strain of the H1N1 flu and survived were immune from the second horribly lethal strain that followed.
So commonsense would suggest that those who got infected by the current wave of the H1N1 flu virus – and we have been told that it is so mild that many people who get infected do not know that they have it – are very likely to be immune should a more lethal variety follow in its wake. However, Dr Darren Hunt, Deputy Director of Public Health issued the following statement at the end of June:
No swine flu parties!
“Swine flu parties are definitely not part of the Ministry of Health’s public health advice. The idea of “swine flu parties” goes against the Ministry’s efforts to contain the influenza A (H1N1) swine flu virus. If people deliberately made themselves ill with this virus, this would have a huge impact on already-stretched health services. Deliberately infecting yourself with influenza A (H1N1) swine flu will put your health at risk. It is also hard to tell at this stage who will be worst affected by this virus.” (5)
History suggests otherwise. In 1918 there was a war on which helped spread the virus and there were no antibiotics. There was also no Tamiflu – but it apparently only shortens the illness by a day anyway. (5)
Many of the factors that contributed to the high death toll in 1918 are alive and well in the both the developed and developing worlds today. Extensive air travel ensures that any new Influenza A virus will spread quickly. Our overuse of antibiotics threatens to reduce their effectiveness. The Chinese government is as corrupt and secretive as ever as evidenced by the latest melamine in infant formula scandal, and its duplicity over the outbreak of the SARS virus in Guangdong in 2003.
While the Ministry of Health can be commended for keeping the public informed of what was happening and why they were taking the seemingly extreme measures that they were, it is not enough. The Ministry must tell us what they don’t know as well as what they do know. They must also allow us to make our own choices about how to deal with this.
References
1. Mike Davis “The Monster at our Door.” 2006.
2. John M. Barry “Pandemics: Avoiding the mistakes of 1918.” Nature Vol 459 21 May 2009.
3. Knobler S, Mack A, Mahmoud A, Lemon S, ed. “1: The Story of Influenza”. The Threat of Pandemic Influenza: Are We Ready? Workshop Summary (2005). Washington, D.C.: The National Academies Press. p. 75.
4. Niall Johnson and Juergen Mueller. “Updating the Accounts: Global Mortality of the 1818-1920 ‘Spanish’ Influenza Pandemic,” Bulletin of the History of Medicine Vol 76. 2002.
5. Dr Paul Trotman “The Pandemic Panic” Sunday Star Times 28 June 2009.
July 2009