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Why the swine flu isn’t a major threat

Posted by medconsumers on September 24, 2009

For the last 15 years, physician and epidemiologist Tom Jefferson, MD, has made it his mission to conduct extensive reviews of all studies of seasonal influenza vaccines. With colleagues at the Cochrane Collaboration, Dr. Jefferson has co-authored over 10 Cochrane reviews to answer a wide range of questions such as: do these vaccines reduce the chance of getting influenza or reduce the risk of complications, hospitalizations and deaths in elderly people, children, healthy adults and asthmatics? Based in Rome, Italy, Dr. Jefferson has published extensively and is arguably the world’s leading authority on the quality of the evidence supporting seasonal influenza vaccines. As we head into winter, the U.S. media is reporting a new, more ominous viral threat that may well become a pandemic. It is, of course, the swine flu, now known as the H1N1 virus or the 2009 H1N1 virus. Dr. Jefferson is interviewed by Maryann Napoli.

MN: Thanks for sending me that September 16, 2009 letter from the Health Protection Service of Australia. It made me turn my attention to that part of the world. Now that winter is ending in the southern hemisphere, what has happened in Australia doesn’t appear to be a pandemic. There were 131 H1N1 deaths out of a population of nearly 22 million people. Is it fair to conclude that the H1N1 virus did not turn out to be a pandemic in Australia?

TJ: Yes, you may conclude that the H1N1 virus is not the threat that it has been portrayed to be.

MN:
And no H1N1 vaccine was available to Australians in time for their winter season.

TJ:
Yes, that’s right. But notice that I did not answer the second part of your initial question about whether Australia experienced a pandemic. That’s because the definition of pandemic has changed on the World Health Organization’s (WHO) website since May 2009. The earlier version defines pandemic as: “An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in epidemics worldwide with enormous numbers of deaths and illness [emphasis in the original document].” In the lookalike document that currently appears on the WHO Web site, the definition of pandemic has changed to: “A disease epidemic occurs when there are more cases of that disease than normal. A pandemic is a worldwide epidemic of a disease. An influenza pandemic may occur when a new influenza virus appears against which the human population has no immunity.”

MN: The phrase “enormous numbers of deaths and illness” is gone. And we now have a lower threshold for calling something a pandemic

TJ:
The definition we’re left with makes the difference between seasonal influenza and pandemic influenza a matter of debate.

MN: What do you think is going on?

TJ: I am wondering if this means that the world will always be in a pandemic. The world will always have to be doubly vaccinated and the world will always be spending a huge amount of money for vaccines, and of course, buying anti-viral drugs by the barrel load. Journalists and others have contacted WHO to find out why the change in definition, and they are always told that someone will get back to them, which never happens.

MN: What about funding? The WHO funded the osteoporosis meeting in 1993 where the definition of osteoporosis was expanded. Do you know whether the same thing may have happened here?

TJ:
No, I don’t, but when you look at the WHO pandemic preparedness document, which is 62 pages long, you see in the citation count only 2 references for hand washing, 3 for masks, 1 for gloves, 23 for vaccines and 18 for anti-viral drugs. What WHO should be pushing worldwide, especially for poor countries, are these public health interventions; instead, it’s pushing pharmacologic interventions. We now have clear evidence from our reviews that pharmaceutical industry-sponsored influenza vaccine studies have risen in importance and visibility, considerably more than non-pharmaceutical industry-sponsored studies. However, this is not explained either by size or quality of the studies which is the same. The likely, and very unpalatable, explanation for this finding is that the most prestigious scientific journals are more likely to print pharmaceutical industry-sponsored studies probably because of the money they make out of selling reprints of the studies and advertising space.

MN:
But Tom, many who read this will say, “Yes, maybe a lot of people are going to make money from our fear, but I’ll still get the vaccine.”

TJ:
First of all, it’s not “maybe” a lot of people are going to make money. Here’s a swine and bird flu stocks index, which tells you just how much money vaccine companies made in the last six months. So if you want to know how the pandemic is going, you can consult this Web site. I call it a “pandemiometer,” the barometer of the pandemic. Don’t forget to read the comments at the end of the page and the insights from the contributing pundits.

MN:
Don’t you mean that this Web site is a barometer of the fear of the pandemic?

TJ:
No, I think it is a reflection of what this pandemic really is: a commercial operation.
Why else would the Australian government plan to immunize millions of people after the epidemic with a partially evaluated vaccine?

MN:
The Food and Drug Administration recently announced approval for four new vaccines against the H1N1 virus. They come with the usual warnings for people with allergies to eggs and possible “unexpected or rare serious adverse events.” Do you have any other reservations about these vaccines?

TJ:
Yes, I do. I am aware of only one published study. It appeared recently in the online version [September 11, 2009] of the New England Journal of Medicine. I have four problems with this study, which was done in Australia. 1) It was tiny, only 240 adults. The authors made reassuring statements about Guillain–Barré syndrome, which is ridiculous because GBS occurs in one out of 750,000 to 1 million vaccinations, and this study only had 240 participants; 2) one third of these volunteers had side effects that resembled influenza-like illness (headaches, sore throats, etc.), so they were vaccinating to prevent symptoms that they were causing; 3) there was no placebo arm in the study [a group that was injected with an inert vaccine], yet there’s no ethical excuse for not having a placebo arm because these are experimental vaccines; and 4) the description of what additive substances [ingredients that boost the immune response] were in the vaccine was unclear. We know that there is thimerosal [mercury] in this H1N1 vaccine, but its manufacturer did not say whether there are additional substances like aluminum, which can be found in many other vaccines. We just don’t know. And they are advising this vaccine for pregnant women and children over six months of age!

MN:
Can you just back up and explain how vaccine studies determine whether a new vaccine should be approved?

TJ:
In all our reviews of the studies involving seasonal influenza vaccines, we always looked for real outcomes, i.e., cases of influenza, bronchitis, pneumonia. [In other vaccine studies like this new one from Australia], researchers look at the quantity and quality of antibodies [in the bloodstream] of the volunteers once they are injected with an experimental vaccine. If they produce a pre-set quantity considered to be “protective,” then it is assumed that once vaccinated, people will be protected. So the key question is how these laboratory markers relate to the protection of people. To answer the question we reviewed all influenza vaccines studies from 1948 to 2007. A straight answer is made difficult by the poor quality of these studies, but vaccines have performed very poorly especially in the elderly (for which they are universally recommended). So if this is the track record, why are researchers pursuing the same old tired and fruitless road?

MN:
Yes, you made that so clear when I interviewed you in 2006 after you published an extensive report in the British Medical Journal. What about that CDC-generated statistic that the media hauls out each year to scare us into getting vaccinated: 36,000 U.S. deaths each year from influenza? It never changes. And when you think of it, 36,000 out of 300 million Americans is miniscule.

TJ: We know that in the last 20 years in the U.S., the seasonal influenza-related mortality rate is flat, despite the fact that over the years a higher and higher number of people have been getting influenza vaccines.

MN:
Re the seasonal influenza vaccine which the CDC usually recommends for certain populations like children under age two and the elderly…

TJ:
There is no evidence whatsoever that seasonal influenza vaccines have any effect, especially in the elderly and young children. No evidence of reduced [number of] cases, deaths, complications.

MN:
Obviously, there’s no Cochrane review on the horizon for the H1NI virus.

TJ:
Of course not, there’s no data yet to review. There is no problem with the H1N1 virus. It’s no different from any other seasonal virus. In fact, it looks—from the Australian experience—like it’s going to be milder and it can be handled with public health measures, such as hand washing, masks.

At the end of this interview Dr. Jefferson was asked if he had any conflicts of interest to report about influenza vaccines. His response: “Yes: I am publicizing my work. But no, I have no financial conflicts.”

More articles written during and after the swine flu “pandemic” of 2009-2010:

“WHO & Pharma draw fire over H1N1 hype”

“Swine flu in the U.S.—final death count”

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19 Responses to “Why the swine flu isn’t a major threat”

  1. Karen Campbell said

    While saying the H1N1 vaccine is safe, producers of that vaccine have been granted immunity from lawsuits by the Canadian government. That idea is sure to “catch on”!

    • medconsumers said

      Here in the U.S., vaccine companies have already been granted immunity. In the wake of the 9/11 tragedy, Congress passed a federal law that allows vaccine companies to be protected from liability if anyone suffers a vaccine-related injury. Authorities need only declare a public health emergency for the protection to go into effect. A government fund will purportedly cover the injured people. Another legacy from the Bush era is the idea that it is the fear of lawsuits that deters pharmaceutical companies from joining the vaccine market. According to Public Citizen, the truth is that there is no economic incentive for them to do so and lawsuits are not a factor in the current shortage. See this press release for the 2004 report from Public Citizen entitled, “Flu Vaccine Shortage: Another Example of How Bush Dis-Torts the Truth About Lawsuits.”

  2. This report is very important as it clarifies the change in the trend from the WHO being a people’s watchdog for humans around the world, and now a spokes-group for the big businesses who have the ability to fund large campaigns for products that are not necessarily the best for humans. There are billions at stake in vaccine programs. What professional can go up against his/her company if everything is not correct with a product when billions are at stake? I have personally witnessed the cover-ups internally of bad product for the sake of the profits. We must be careful and evaluate each new product release with a certain amount of skepticism. Corporations must earn our trust, not be given carte blanche to the checkbooks.

  3. GeeOh said

    With regard to the following statement

    “We know that in the last 20 years in the U.S., the seasonal influenza-related mortality is flat, despite the fact that over the years a higher and higher number of people have been getting influenza vaccines.”

    I am wondering if this accounts for population growth. As more people are getting flu vaccinations as there are more people. The fact that flu mortality rates are flat shows the the flu vaccine is working.

    • medconsumers said

      Dr. Jefferson meant to use the word ‘rate’ in that sentence (I just checked with him). Use of the word ‘rate’ takes into account your concerns about the increase in population growth. Death rates are usually calculated as the number of deaths per 1,000 of the population per year. While you say that “the fact that mortality rates are flat shows the vaccine is working” – it actually suggests the opposite conclusion. No change in mortality rates is evidence that immunization is not effective in preventing fatal flu cases. Thank you for pointing out the omisson. It has been corrected. As for the 36,000 deaths, that CDC-generated statistic is purportedly the annual number of influenza-related deaths in the U.S. Here’s an excellent critique of that statistic. Four years old but still relevant.

  4. Andrew Ward said

    I salute Dr Jefferson for speaking up against the tide of vaccination fundamentalists and questioning the validity of the seasonal ‘flu vaccines. It has always been my suspicion that it does nothing, whilst at the same time affecting susceptible people in an adverse way. I have been in homeopathic practice for over 20 years and have certainly seen the detrimental effects of vaccines especially as the load increases year by year.
    By the way just to pick you all up on the REAL idea behind homeopathy – you cannot have a “homeopathic” remedy for the ‘flu. Its a misconception based on poor understanding of the principles of our science. A “homeopathic” remedy only becomes homeopathic ie active/effective when the symptoms, which it can produce in a proving on healthy volunteers, match those of the person suffering with the illness eg ‘flu. Therefore it is illogical and wrong to suggest that a “homeopathic” remedy can prevent ‘flu in an individual or a pandemic. You have to have symptoms in order to prescribe the correct remedy for a given illness. No symptoms No remedy. Homeopathy is a science of individualisation and yet everyone wants to use it in the same way as a vaccine for mass treatment. There is no evidence that it can prevent anything – it would not be logical. Yes it can successfully treat the ‘flu as was seen in the previous pandemics where the mortality rates were only around 1% as opposed to 30% with allopathic approaches.
    That is why Occilococcinum shows no effect in prevention of ‘flu.

  5. alex farguson said

    There is obviously a lot to know about this. I think you made some good points in Features also.

  6. Ed Smih said

    Tha the flu death rate has remained the same over the past twenty years despite ever increasing use of flu vaccine is a very interesting fact. While not a formal clinical study, I think this says it all …. flu vaccines don’t lower flu death rates. Over the past 25 years I’ve had one very mild case of flu … lasted about 2 days … and I’ve never had a flu shot, nor any other vaccines for the past 30 years. I use a natural foods diet and herbs instead.

  7. Raymond Richard Neutra MD said

    I agree with Dr Jefferson’s critique of our reflexive faith in technological ( and incidentally lucrative) as opposed to life-way- change solutions to the worlds problems. This goes back in public health to the arguments in the early 20th century about technology-based public health ( don’t bang your head against the hopeless task of social injustice, just vaccinate folks and stay out of politics) and the social-systems approach to public health. I have argued that it would have been CLEARLY cost beneficial to invest a million dollars a year to fostering family and neighborhood preparedness for home nursing, mutual aid and stocking-up to anticipate possible failures in food and water distribution from a pandemic or a California earthquake AS WELL AS preparing for the delivery of vaccines and anti virals.

    That being said, what alternative is Dr Jefferson proposing? Don’t offer vaccine until a randomized trial of 1 million vaccinated and 1 millon placebo vaccinated people have demonstrated some level of efficacy and less than a de minimis rate of adverse side effects? I am NOT asking this question in a reductio ad absurdum ploy to discredit his thoughtful comments, but we need to have a positive alternative to the current technological-fix fantasy world. There should be a probablistic decision analysis and an ethical analysis well in advance of the pandemic that should inform our approach, with anticipated pausing points to absorb unanticipated developments. We should be working on this, so that if there is a critique of the present approach, those of us who are not in the midst of the fray can come up with the outlines of a better alternative for next time ( and there will always be a next time).

    With regard to the definition of pandemic, the label should be crafted to trigger certain precautionary cost effective and just societal actions that decrease the case fatality and perhaps incidence of the disease in countries that have not yet been hit. If such societal actions are available ( and Jefferson agrees that there are some non-vaccine preparations such as those I mention in my powerpoint) then the definition of “pandemic” should not require wide spread death. In any case, pandemics of flu have a nasty history of changing case fatality as the virus mutates.

    Raymond Richard Neutra MD Dr.PH ( retired Chief, Div of Env and Occ Disease Control CA Dept PH)

    • medconsumers said

      Excellent points, especially the one about the time it takes to do a randomized trial. You’re correct, of course, but the way the latest vaccine is usually portrayed to the public each fall, many people assume it has been thoroughly tested and proven to reduce incidence, deaths and complications—all with no side effects beyond the occasional fever or skin reactions. The U.S. flu-related death rate hasn’t changed in 20 years, as Dr. Jefferson said in this interview, while noting that the seasonal vaccines don’t have much of track record. According to the Wall Street Journal (7/16/09), the U.S. government signed contracts with four companies worth a total of almost $1 billion to purchase ingredients used to make vaccines against the H1N1 virus. Let’s hope there’s careful, independent follow-up to see whether taxpayers got their money’s worth this time around.

  8. Alexis Bartlo said

    How do you reconcile this interviewee’s opinion with the following:

    http://www.huffingtonpost.com/larry-brilliant-md/love-in-the-time-of-swine_b_293971.html

    • medconsumers said

      What’s to reconcile? Dr. Larry Brilliant’s article for the Huffington Post does not address what we care about the most: the evidence for vaccine effectiveness and for calling something a pandemic.

    • jeannie said

      Is spite of his wonderful name, Larry Brilliant is an epidemiologist who took Tamiflu, on overpriced big pharma moneymaker that can reduce your flu by possibly as much as, oh, a whole day! Maybe! He took ibuprofen to reduce a fever which never got over 102 and which was his body’s attempt to eradicate the virus. And he managed to infect one of his children. Since Tom Jefferson is certainly also a great name, I think all the chips are in his pile on this one.

  9. […] dig deeper into the issues surrounding swine flu and vaccination, it’s worth having a read of this interview with Dr Tom Jefferson, a medically trained epidemiologist who has long experience as a reviewer for […]

  10. There are homeopathic remedies for flu. They all contain Oscillococcinum and are used extensively in Europe. The problem is how to let people know. There’s not enough profit in making these remedies to afford the advertising and lobbying that the pharmaceutical companies do. Could you mention Oscillococcinum in one of your newsletters? Also, Im surprised that they are still using thimerosol as a preservative in the vaccines. I thought that had been discontinued because of the mercury.
    Thank you for your information.

    • Sylvia is partially correct and partially wrong. There ARE homeopathic medicines for the flu, but they do NOT all contain “Oscillococcinum.” Oscillococcinum is just one of many homeopathic medicines for the flu, though it is the most researched medicine for the flu. In fact, four large studies have shown its efficacy in the TREATMENT of the flu, but there have also been three large studies that tested its efficacy in the PREVENTION of the flu (and all of these studies showed that it was not effective).

      The reference for this review of research is: Vickers AJ, Smith C, Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes (Cochrane Review) The Cochrane Library, Issue 4, 2005.

      Another study conducted on homeopathic medicines and the flu was with a homeopathic formula called GRIPP-HEEL (from Germany but available worldwide):

      Gripp-Heel(R) is a homeopathic formula preparation frequently used in the treatment of respiratory viral infections such as various types of influenza and the common cold. The antiviral activity of Gripp-Heel was studied in vitro on human pathogenic enveloped and nonenveloped RNA and DNA viruses (Glatthaar-Saalmuller, 2007).

      Reference: Glatthaar-Sallmuller, B. In vitro Evaluation of the Antiviral Effects of the Homeopathic Preparation Gripp-Heel on Selected Respiratory Viruses, Can J Phyiol Pharmaocl. 2007 Nov;85(11):1084-90.

      For further information on homeopathy and homeopathic research, consider exploring: http://www.homeopathic.com

  11. Margaret Farnsworth said

    The report jibs completely with the information coming from my MD homeopath. He has been warning his clients to avoid getting vaccinated for the same reasons you have just stated: no proof that they work. Thanks for the conformation. I have always avoided flu vaccinations, and while I’ve had a few flu episodes over my 81 years, I’ve always returned to good health with some newly acquired antibodies of my own body’s making.

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