Dr TJ talking about the flu shot

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Two separate reviews of medical data on the effectiveness of vaccinating people to prevent influenza showed there were no benefits to being vaccinated for the flu.

Epidemiologist Dr. Tom Jefferson, who is with theCochrane Vaccines Field, participated in two different reviews of medical studies related to influenza vaccines. Both reviews were published by theCochrane Collaboration. Dr. Jefferson summarized the conclusions of the reviews in a podcast.

"... The reviews are very different in their content but not in their conclusions. Both ... highlight serious problems with the current evidence base.

... The implausible results of the studies are that the vaccines appear effective against those outcomes least likely to be caused by influenza viruses; such as influenza-like illness, hospitalization and death from all causes. In contrast they show only modest or no effect against influenza and hospitalization from pneumonia.

... our reviews include a number of studies funded by industry. An early systematic review of all influenza vaccine studies published between 1948 and 2007 found that industry-funded studies were published in more prestigious journals and were cited more than other studies but their methodological quality and size were the same as the other studies. Studies funded from public sources were significantly less likely to report conclusions favourable to the vaccines.

In conclusion we have no reliable evidence on the effects of influenza vaccines on the elderly and health care workers who work with the elderly. What we do have evidence of is widespread manipulation of conclusions and spurious notoriety of the studies."

While the doctors did not look at the outcome of the H1N1 vaccine, the conclusions reached imply, when extrapolated to the H1N1 vaccine, that many countries may have thrown away millions of dollars on the vaccine in 2009, when less money could have been spent promoting more effective preventative measures, such as hand-washing, wearing masks and wearing gloves.

In Vaccines for preventing influenza in the elderly, Doctors Jefferson, Di Pietrantonj, Al-Ansary, Ferroi, Thorning and Thomas reviewed 40 years worth of gathered records on influenza shots given to adults 65 years and older, which included 75 studies. The reviewers concluded more testing was required before anyone could say flu shots are effective.

"The available evidence is of poor quality and provides no guidance regarding the safety, efficacy or effectiveness of influenza vaccines for people aged 65 years or older. To resolve the uncertainty, an adequately powered publicly-funded randomised, placebo-controlled trial run over several seasons should be undertaken."

In the second review, called Influenza vaccination for healthcare workers who work with the elderly, Doctors Thomas, Jefferson and Lasserson looked at five available studies for the identified population group and concluded

"... there is no evidence that vaccinating HCWs prevents influenza in elderly residents in LTCFs. High quality RCTs are required to avoid risks of bias in methodology and conduct, and to test these interventions in combination."

A False Pandemic?

Recently, the Council of Europe held a panel discussion on the influence of pharmaceutical companies on the World Health Organization after Dr. Wolfgang Wodarg called the H1N1 pandemic a "false pandemic. Dr. Wodarg asserted

"... pharmaceutical companies have influenced scientists and official agencies, responsible for public health standards, to alarm governments worldwide. They have made them squander tight health care resources for inefficient vaccine strategies and needlessly exposed millions of healthy people to the risk of unknown side-effects of insufficiently tested vaccines."

A report is being prepared for the Council of Europe and is anticipated to be ready later this year.

Dr. Jefferson has been critical of the WHO's response to the H1N1 outbreak. In a 2009 interview withMaryann Napoli in 2009, Dr. Jefferson noted

"... in 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"

The WHO pre-approved nine different H1N1 vaccinations from a total of 17 submitted. The WHO has determined which companies the United Nations can purchase H1N1 vaccine from. Those pharmaceutical companies include Novartis, Sanofi Pasteur, MedImmune, GlaxoSmithKline, and CSL.

Follow the Money

It might be a sticky bit of business to prove that the WHO was influenced by pharmaceutical companies. However, it is readily evident that those pharmaceutical companies that had their H1N1 vaccines pre-approved by the WHO have benefitted.

Novartis has three different swine flu vaccines, and all were pre-approved by the WHO. Sales of its swine flu vaccines boosted company revenues by 8% in 2009.

Australia-based CSL is the only company in the Southern Hemisphere cleared by WHO to produce a swine flu vaccine, and the company experienced a 23% increase in 2009 profits, which the company attributed to sales of its swine flu vaccine.

MedImmune, a company owned by AstraZeneca, landed a contract from the United States for a swine flu vaccine in the same month the WHO declared the pandemic. The U.S. also awarded contracts to GlaxoSmithKline, Novartis and Sanofi Pasteur. AstraZeneca saw a 23% increase in its 2009 profits, which it also attributed to its swine flu vaccine. The company announced it is cutting 8,000 jobs this year.

Sanofi Pasteur said it's last quarter of 2009 saw a 10% increase in profits due to swine flu vaccine sales.

The biggest winner was GlaxoSmithKline, which reported a 66% increase in profits in the 4th quarter of 2009. The gain was attributed to sales of the swine flu vaccine. The Dutch government is trying to recoupsome of the money spent on the H1N1 vaccine by selling it back to GlaxoSmithKline.

Baxter, which produced a swine flu vaccine approved for use in Europe, but not pre-approved by the WHO, only netted a 1% increase in profits for its 4th quarter, 2009.

Lessons Learned

While the WHO has toned down its approach to the pandemic since last year, it has not declared thepandemic over. Because the pandemic is still sweeping through many countries, the WHO is coordinating the distribution of H1N1 vaccines.

Until the studies Dr. Jefferson and his colleagues have called for have been conducted by credible public agencies, people should be asking questions about recommendations for influenza vaccinations of all varieties. Consumers should question reports on the effectiveness of flu vaccines, such as one just issued by Baxter, just as they should be cautious about new recommendations on flu vaccinations. Smart consumers will ask who funded the study, and who will profit from the recommendation.

And then, just to be sure, perhaps the public should remain calm in the face of warnings about pandemics while Dr. Jefferson and his colleagues vet the credible studies that prove flu vaccines provide protection.