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12/28/2010 10:29:00 AM
Recent studies bolster earlier evidence: Flu shots not beneficial
Mercury in vaccines sparks debate about safety

Richard Moore
Investigative Reporter


Two recent studies published by the Cochrane Collaboration are supporting what earlier evidence has shown - and what some national public health officials have begun to acknowledge - there's no evidence flu shots work effectively, especially in reducing flu-related deaths among the elderly.

The Cochrane Collaboration describes itself as an international, non-profit, independent organization whose mission is to ensure the availability of up-to-date and accurate information about the effects of health-care interventions. It produces systematic reviews of such interventions and compiles scientific evidence, such as clinical trials and other studies, about their effects.

In an ongoing study published in 2009 and updated this year, entitled "Vaccines for preventing influenza in healthy adults," scientists said they found no plausible substantiation that the flu vaccine prevented death or hospitalization from flu-related complications and only marginally reduced the number of days of lost work attributed to the illness.

The study's goal, the researchers stated, was to "identify, retrieve and assess all studies evaluating the effects of vaccines against influenza in healthy adults."

The researchers, led by Dr. Tom Jefferson, a British epidemiologist and chief of the Vaccine Field Group at Cochrane, reviewed studies conducted between Jan. 1, 1966, and June 2010. The authors included 50 reports, of which 40 were clinical trials involving more than 70,000 people.

What they found was shocking. When the vaccination matched the viral strains actually circulating that season, with a high circulation - an uncommon occurrence - 4 percent of unvaccinated people developed symptoms compared with 1 percent of vaccinated people. In the more common years where vaccines did not match the circulating strain, two percent of unvaccinated people got the flu compared with 1 percent of those vaccinated.

In testimony earlier this year before the Parliamentary Assembly of the Council of Europe, Jefferson put those numbers in perspective.

"After reviewing more than 40 clinical trials, it is clear that the performance of the vaccines in healthy adults is nothing to get excited about," Jefferson said. "On average, perhaps one adult out of a 100 vaccinated will get influenza symptoms compared to two out of 100 in the unvaccinated group. To put it another way, we need to vaccinate 100 healthy adults to prevent one set of symptoms."

What's more, the study found no credible evidence the vaccines afforded any protection against complications such as pneumonia or death but did increase the potential side effects.

"Vaccination had a modest effect on time off work and had no effect on hospital admissions or complication rates," the researchers stated in the study. "Inactivated vaccines caused local harms and an estimated 1.6 additional cases of Guillain-Barré Syndrome per million vaccinations."

Those results, as bad as they were, might actually overstate the case for vaccine effectiveness, the researchers cautioned, because many of the studies - 15 of 36 trials with funding declarations - were industry initiatives.

Jefferson and his colleagues said they found a systematic tendency for prestigious medical journals to publish and cite industry-funded studies, while less publicized studies funded from public sources were significantly less likely to report conclusions favorable to the vaccines.

"Our results may be an optimistic estimate because company-sponsored influenza vaccine trials tend to produce results favorable to their products and some of the evidence comes from trials carried out in ideal viral circulation and matching conditions and because the harms evidence base is limited," the study stated.

So what about the efficacy of getting vaccinated?

The 2009 report determined there was no real scientific rationale to support routine flu shots for healthy adults.

"The results of this review seem to discourage the utilisation of vaccination against influenza in healthy adults as a routine public health measure," the study concluded. "As healthy adults have a low risk of complications due to respiratory disease, the use of the vaccine may be only advised as an individual protection measure against symptoms in specific cases."

The 2010 update, which reviewed additional studies, offered no change in that conclusion.

A major part of the problem, the researchers explained, is that while the flu vaccine might work against certain influenza strains, those represent only a small fraction of flu-like diseases - diseases for which the vaccine simply won't work.

"Over 200 viruses cause influenza and influenza-like illness which produce the same symptoms (fever, headache, aches and pains, cough and runny noses)," the authors wrote. "Without laboratory tests, doctors cannot tell the two illnesses apart. Both last for days and rarely lead to death or serious illness. At best, vaccines might be effective against only influenza A and B, which represent about 10% of all circulating viruses."

The elderly

The Cochrane Collaboration and Jefferson - along with lead author Dr. Roger Thomas of the University of Calgary - published another study in 2010, this one analyzing the effects of influenza vaccination for health-care workers who work with the elderly.

More precisely, the scientists stated, because health-care workers' influenza rates may be similar to the general public, and because they may transmit that influenza to patients, effective vaccination would likely reduce transmission rates.

To test that hypothesis, the study looked at four randomized controlled trials involving the vaccination of health-care workers and the subsequent repercussions for people over the age of 60 in long-term care facilities. Specifically, they measured laboratory proven influenza, lower respiratory tract infections, admissions to hospitals and deaths from pneumonia.

The study's conclusion? Vaccinating health-care workers who looked after the elderly in long-term care facilities had absolutely no impact among the elderly on the incidence of laboratory-proven influenza, pneumonia or deaths from pneumonia.

That, too, was a stirring conclusion because the elderly are an especially targeted population group in government flu vaccine campaigns, and the CDC has repeatedly said groups coming into frequent contact with the elderly pose an accelerated risk of spreading the disease unless they are vaccinated.

Not only did the results show no increase in risk because health-care workers were not vaccinated, but, the trials indicated, health-care workers themselves tended to dismiss the need for vaccination.

"Healthcare workers have lower rates of influenza vaccination than the elderly and surveys show that healthcare workers who do not get vaccinated do not perceive themselves at risk, doubt the efficacy of influenza vaccine, have concerns about side effects, and some do not perceive their patients to be at risk," the paper stated.

The bottom line?

The researchers said there was no evidence of vaccine stand-alone effectiveness, and they suggested other more traditional preventive methods might be effective to curb the spread of influenza.

"We conclude that there is no evidence that only vaccinating healthcare workers prevents laboratory-proven influenza, pneumonia, and death from pneumonia in elderly residents in long-term care facilities," the study stated. "Other interventions such as hand washing, masks, early detection of influenza with nasal swabs, anti-virals, quarantine, restricting visitors and asking healthcare workers with an influenza-like illness not to attend work might protect individuals over 60 in long-term care facilities and high quality randomised controlled trials testing combinations of these interventions are needed."

Earlier studies

The recent studies reinforce already published - but not highly publicized - analyses that flu shots are not effective enough, or at all, to warrant a mass vaccination policy, even among the elderly.

One such analysis did appear in The Washington Post in 2005, written by Steven Woloshin, Lisa Schwartz and Gilbert Welch, physician-researchers in the VA Outcomes Group in White River Junction, Vt., and faculty members at the Dartmouth Medical School.

In the piece, the authors observed that public health officials had run vaccine campaigns based on fear for years, though the statistics employed in those campaigns could not withstand logical scrutiny.

"A vaccination poster distributed by the U.S. Centers for Disease Control and Prevention (CDC), for example, emphasizes that '36,000 Americans die of flu-related illnesses each year,' implying that the vaccine could prevent many of these deaths," the authors wrote.

The problem was, officials had been using those same fatality numbers for years even as vaccination rates had skyrocketed. A reasonable person might wonder: Why hasn't the number of deaths gone down?

"By choosing to highlight the annual number of flu deaths, the CDC employed an attention-grabbing tactic often used by public health and disease advocacy groups," the authors wrote. "It's a tactic readers should be inoculated against if they want a clear picture of the risks they face."

In fact, they continued, it was very difficult to know how many people were actually dying from flu-related diseases because those diseases share symptoms with many diseases - a fact Jefferson and his researchers reiterated - and because people most likely to die a flu-related death are also at high risk for many other causes of death.

In addition, they stated, when it comes to measuring death prevention, most flu vaccine effectiveness data comes from observational studies in which scientists count the number of deaths among people who did or did not get the vaccine rather than from more scientifically rigorous randomized trials, which, the authors asserted, were considered the gold standard for medical evidence.

"Only five randomized trials have examined the effectiveness of the flu vaccine," they reported. "In these studies, patients were randomly assigned - a selection technique equivalent to the flip of a coin - to get either a flu vaccine or a placebo injection. But none of these studies looked at whether the vaccine prevents death. Instead, the scientists measured who developed a flu-like illness."

In the absence of randomized trials, the authors suggested looking at time trends in flu vaccine rates compared with flu-related deaths in the elderly as one way to gauge vaccine effectiveness.

The results were again shocking. While there was almost no change in the flu-related death rate among the elderly between 1980 and 1998, vaccination rates during that time jumped by 148 percent.

By 1998, the vaccination rate among the elderly had risen to 62 percent, up from approximately 25 percent in 1980, yet flu-related deaths stayed at about 200 per 100,000 of the elderly population.

That's still a small number. According to the CDC, 90 percent of flu-related deaths occur among people age 65 years and older, but the chance of a flu-related death for people in that age group is only about two in 1,000. Put another way, the chance of not dying from flu for those aged 65 and older is 998 out of 1,000

As for measuring the effectiveness of the flu vaccine in reducing the number of days lost from work, the authors of the 2005 Post piece reported findings similar to those of Jefferson.

"On average, there are about 0.16 fewer days lost from work per person vaccinated," the authors wrote. "Another way of saying this is that about 5 percent of those vaccinated avoid missing about three days of work because of the flu . . . The other 95 percent vaccinated got no benefit."

Earlier this year, a leading doctor in the mainstream medical community acknowledged what the studies had been reporting: Flu vaccines just don't work very well, especially among the elderly.

Michael Osterholm, the director of the University of Minnesota's Center for Infectious Disease Research and Policy, coughed up the admission at a national conference on vaccine research earlier this year, according to a Minnesota Public Radio report.

"These 36,000 deaths that we keep talking about with the flu, that we want to get people vaccinated for so they don't happen, really is not going to occur. And we have to be honest about that," MPR quoted Osterholm as saying.

Flu campaigns continues

Despite the growing body of evidence, the federal government, including the CDC, state health departments, various advocacy groups and private corporations and their nonprofit research arms all continue to push flu shots every season, as the attempt to vaccinate virtually everybody continues.

This year, for the first time, the CDC has recommended that everyone six months and older get vaccinated, including pregnant women. In previous years, the CDC stopped short of that all-inclusive goal, urging only certain at-risk groups to get the vaccine. According to the CDC website, "vaccination is the best protection against contracting the flu."

Large nonprofit companies such as the RAND Corporation provide artillery for the vaccination foot soldiers. Indeed, that company is recommending a redirection of research dollars from biomedical efforts to the study of social and behavioral sciences - in other words, they want to study the best methods to change the minds of those reluctant to be vaccinated.

"The H1N1 flu pandemic exposed the reluctance on the part of many Americans to be vaccinated against the flu, even during a time of crisis," said Katherine M. Harris, a senior economist at RAND, in November. "We need to better understand how to respond to this reluctance before we can be truly prepared for a future flu emergency."

The science that would clarify the best ways to inform and motivate the public is severely underdeveloped, RAND researchers said: "More resources should be channeled into understanding and improving the public's view of flu vaccines before the ongoing biomedical advances can be translated into effective action."

Among RAND's major contributors are Ortho-McNeil Janssen Scientific Affairs, Pfizer, GlaxoSmithKline, and Merck, all of which are researching or manufacturing flu vaccines, or supplying those manufacturers.

Safety of the vaccine

Meanwhile, while the discourse gets hotter about the vaccine's effectiveness, the debate about its safety continues to rage.

Those who support vaccination say it's better to be safe rather than sorry, while detractors say the vaccine could pose serious health risks.

Vaccine detractors point to studies showing an increase in cases of Guillain-Barré Syndrome as one potential side effect, but mercury in the vaccines is a much bigger issue. While mercury has been removed from most vaccines, at least in larger amounts, it is still a substantive component of most flu vaccines.

The possibility of mercury poisoning is acute, critics say, especially in young children and for pregnant women.

For one thing, as The Lakeland Times reported earlier this year, the concentration of mercury in a multi-dose vaccine five-milliliter vial stands at 50,000 ppb (parts per billion). Consider that the EPA requires liquid waste exceeding 200 ppb of mercury to be disposed of in a special hazardous waste landfill, and that drinking water cannot exceed two ppb mercury.

Is it really safe to inject infants and pregnant women with levels of mercury 250 times higher than hazardous waste levels? critics ask.

Indeed, according to the CDC guidelines, the higher content mercury shots are offered to children six month of age or older.

It should be noted that the vaccines contain a different type of mercury - ethylmercury, as opposed to the methylmercury found in drinking water, fish and released through industrial processes - and vaccine proponents call ethylmercury the "not-so-bad" mercury because it does not bio-accumulate as rapidly.

Nonetheless, both are classified as neurotoxins, and some say ethylmercury should be considered as potent as methylmercury in developmental policymaking, in the interests of protecting public health.

That's because, they say, while ethylmercury is less acutely toxic than methylmercury, infants and young children may be more susceptible than adults, and no substantial studies exist to compare the potencies and impacts of ethylmercury and methylmercury in developmental circumstances.

Detractors also point to a confessed lack of knowledge by drug-makers themselves about the vaccines' effect on pregnant women.

For example, a July 2010 material safety data sheet for Fluvirin, one of the major vaccines available this year, does not contraindicate the vaccine for pregnant women, as it does for children under the age of four, but the sheet acknowledges that it is "not known whether Fluvirin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity."

The company does say the vaccine should be administered to pregnant women only when "clearly needed," but, if CDC recommendations are to be believed, the shot is "clearly needed" for all healthy pregnant women, and there are no alternative vaccines - the same warning appears on the other flu vaccine medical data sheets as well.

Interestingly, in other areas, the government is stepping up its warnings about mercury ingestion. For example, the Federal Trade Commission recently required compact fluorescent light bulb manufacturers to put mercury labeling on packaging, including information on proper handling and cleanup when a CFL breaks in the home, primarily due to the escape of trace amounts of mercury vapor.

Decisions, decisions

If one does decide to receive a flu vaccine, is it possible to obtain a mercury free vaccine?

It is, though it is not probable. According to the CDC, for 2010-11, six influenza vaccine manufacturers were projecting that as many as 160-165 million doses of influenza vaccine would be available; of those, approximately 74 million would be thimerosal (mercury)-free or preservative-free (trace thimerosal) influenza vaccine.

That is to say, less than half of the available vaccines will be mercury free, or what is considered to be mercury free.

And how do you know if your vaccine is really mercury free? According to Consumer Reports, single dose flu shots produced by CSL Limited and Sanofi Pasteur are mercury-free, as are all intranasal vaccines produced by MedImmune; the Novartis single-dose H1N1 flu vaccine has trace amounts of mercury.

In the end, getting a flu shot is a matter of personal choice but one that should be informed. As Woloshin, Schwartz and Welch wrote in The Washington Post, the health community has not always made information readily available.

"To promote vaccine use, many in the public health community have overstated the risk of flu-related death and the effectiveness of the vaccine in preventing it," they wrote. "While the flu vaccine may have some important benefit (less flu-related illness), we really do not know whether it reduces the risk of death."

That's not to suggest that people avoid the vaccines, they wrote; instead, they should weigh the potential risks and benefits.

In his testimony before the European Council, Jefferson was more straightforward.

"Another consequence is the idea that influenza-line illness ("flu") and its ravages can be prevented or minimised with influenza vaccine," he said. "Cochrane reviews show that vaccines could only affect at the most (i.e. if they had 100 percent efficacy) some 7-15 percent of the annual flu burden, since this is the proportion of people with the flu who truly have influenza."

The government's approach to influenza and vaccination, he said, was a fantasy.

"This 'specificity' of approach (go for influenza, disregard all other causes of the flu) is probably based on what I call availability creep (let's concentrate on influenza because that's the one we have specifics for)," he said. "But, if you think about it, it is a wonderful utopian policy against a syndrome as unspecific as this (just think of the role that other viruses play).

"In my opinion, the lack of logic in this thinking is stunning."

Richard Moore can be reached at rmmoore1@frontier.com.



Reader Comments

Posted: Saturday, February 12, 2011
Article comment by: Beatriz Schiller

Dear Richard Moore. I was interested in your articles about vaccines.For the first time in my life I took Fluvirin 2010-11 Vaccine 10/25/10. In December I had pneumonia, for the first time in my life. Can it be related? Please let me know if any other case like mine occurred. Thank you, Beatriz

Posted: Monday, January 3, 2011
Article comment by: David

I would like to add to Dr. Jefferson's comment---
Public health officials stupidity, arrogance, and the damage that they have caused is stunning as well.
These people have literally poisoned a generation of children
and adults---
They have injected unprecendented levels of heavy metals in the
population as well as other chemicals.
The reason why this is happening because the
idiot legislators
gave the vaccine manufacturers immunity from lawsuits.
If we could get just one
trial with a jury and
have the rules of discovery enforced,
all the dirty laundry of
the CDC and the drug companies would be revealed---


Posted: Friday, December 31, 2010
Article comment by: Judith Acosta

Thank you for your work!
It's amazing that the pharmaceutical companies have us so bamboozled.
Judith Acosta
www.wordsaremedicine.com


Posted: Friday, December 31, 2010
Article comment by: MARY HIRZEL

EXCELLENT coverage of this topic by any standard! Many thanks to Mr. Moore. If there were more journalists like Mr. Moore, our world might be in much better shape right now.

Posted: Friday, December 31, 2010
Article comment by: Anne McElroy Dachel

While health officials continue to pretend that the annual flu outbreak is a health care crisis, they ignore the fact that we are now a nation of the chronically ill and disabled. We are the most vaccinated people on earth and some of the sickest.
Anne Dachel
Age of Autism


Posted: Thursday, December 30, 2010
Article comment by: Megan Allen

Thank you for this report. Consumers deserve unbiased information to make informed decision, not scare tactics and blanket statements that "vaccines save lives". The ingredients being injected into our bodies from these vaccines are considered to be toxins, so unless the vaccine is proven overwhelmingly effective, I do not believe most people would chose to receive this chemical cocktail innoculation.

Posted: Wednesday, December 29, 2010
Article comment by: Green Your Life

Read "Vaccination I$ Not Immunization by Tim O'Shea which gives you a very well documented history of vaccines. www.thedoctorwithin.com

The only herd immunity is natural immunity.


Posted: Wednesday, December 29, 2010
Article comment by: Lisa

Hooray! Thank you for that article. I hope that everyone, whether they plan to get a flu shot or not, reads it. I'm from NJ, where flu vaccines are now mandatory for kids ages 6 to 59 months to attend preschool and daycare. Find out more at http://njvaccinationchoice.org

Posted: Wednesday, December 29, 2010
Article comment by: Lisa

Glad to see someone telling the truth about the flu shot. I almost died from a flu shot reaction in Oct 2005. It took 4 years to recover the feeling in my legs. The vaccine court agreed my damage was caused by the shot and settled with me this year.



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