The Flu Vaccine Saga: The Latest Twist
Apples and Oranges Too
2005By F. Edward Yazbak, MD, FAAP REDFLAGSDAILY.COM
The following two statements are frequently heard:
Many have questioned the first statement and wondered how that figure of 30,000 a year was reached, particularly when it is well known that flu seasons, like the weather, are so variable every year.
Some rightfully believe the figure to be a “guesstimate” (1) and many do not believe it altogether.
In any case, regardless of where that magic figure came from, one thing is sure: In our world of vaccine hyperbole, that 30,000 figure will go up, up and away.
Quiche Gorge is a breath-taking deep gorge in Vermont. Beautiful and multi-colored hot air balloons often lift off from the bottom of the gorge and fascinate children, who from a distance, think that the balloons came right out of the ground.
Many of us cynics were just as fascinated with the 30,000 figure that seemed to come out of nowhere. Now, all what we have to do is watch it rise.
In its July-August (2004) issue, the American College of Physicians’ Observer carried the following statement: “Influenza is the sixth leading cause of death for older Americans and infects 5% to 10% of elderly Americans every year. The flu leads to 300,000 hospitalizations and kills 30,000 to 40,000 Americans every year.” (2)
On October 12, 2004, a California Health Service, presumably with information from the California Department of Health and the CDC was still quoting the “old figures”: “Influenza typically impacts 5 to 20% of the population during the flu season. For most, the illness resolves rapidly. However, each year 200,000 persons are hospitalized for flu complications and there are over 30,000 flu related deaths each year. Older adults and persons with significant chronic disease account for over 90% of these deaths”. (3)
Certainly when it comes to the HEALTH of the Nation, a small difference of 100,000 hospitalizations and 10,000 deaths is not a big deal.
The so-called “flu-related deaths” most often result from complications of the disease in people at risk or who have underlying medical conditions.
They are not just due to actual viral invasion.
Whether the so-called “flu-related deaths” were actually flu-related is another story altogether. According to the latest CDC Mortality and Morbidity Weekly Report – for the week ending February 12, 2005- only 12.8% of cultures submitted since October 3, 2004 were positive. Of these, 85% were Influenza A.
In other words, among the 73,000 sick individuals nationwide who were symptomatic enough to warrant a culture, only some 9,000 actually had the virus.
The fact that flu vaccination saved many lives, particularly among the elderly, was more readily accepted by the medical profession and the senior citizens themselves. And this acceptance made the job of the CDC much easier.
That is until a week ago, on February 15 to be exact, when a new study from the National Institute of Allergy and Infectious Diseases (NIAID) was published in the “Archives of Internal Medicine”. (4, 5, 6)
The fact that the number of influenza-related deaths among the elderly kept increasing while the flu vaccination coverage in that particular group was improving steadily and substantially -from about 20% in 1980 to around 65% in 2001- seemed to intrigue the lead author of the study, Lone Simonsen, Ph.D., a senior epidemiologist at the Institute.
With her team, Dr. Simonsen developed "a cyclical regression model" and carefully and methodically estimated influenza-related deaths - and all deaths - among the elderly in the United States during the 33 (Thirty Three) consecutive flu seasons spanning from 1968 to 2001.
The following findings were noted:
In an interview, Dr. Simonsen said that the dramatic increase in vaccination coverage should have led to a dramatic drop in flu deaths. "This is not what we found," she said. "Certainly if this intervention really does reduce winter deaths in the elderly by 50% we would expect to see it. So the mortality benefits are probably very much overestimated."
Dr. Simonsen then commented on the 1997-1998 flu season. The strains included in that season’s vaccine were totally different from those cultured in the fifty states and therefore the vaccination of over 60% of eligible elderly did not actually protect them. Yet there were approximately 5,000 fewer excess deaths in this age group than there were the following flu season, when the same percentage of people were vaccinated with the correct strains.
According to the NIAID study, “there are not enough influenza-related deaths to support the conclusion that vaccination can reduce total winter mortality among the U.S. elderly population by as much as half." This statement surprised everyone and irritated many.
The CDC, having recommended flu vaccination of the elderly for over thirty years, disagreed with the new study, reminded everyone that “36,000” people – mostly seniors- die each year of flu-related causes, declared that the best way to help the elderly was to vaccinate them and reassured everyone that there would not be any policy change.
To make things even more interesting, another smaller study on flu vaccination, this one from the Netherlands, was published in the same issue of Archives of Internal Medicine. It seemed to show that the flu vaccine was effective in decreasing the mortality rate among individuals under the age of 65 with underlying medical conditions.
In an interview, Eelko Hak, PhD, the lead author of the Dutch study said that patients and physicians should be convinced about the benefits of annual influenza vaccination and that “no opportunities should be missed to have all patients recommended for vaccination against influenza".
A spokesman for the American Academy of Family Physicians said the two studies are "a fascinating exercise in 'What is truth?". "What you see in the two papers is a difference between observational and statistical findings" he said. "Statistical studies like this one tend to underestimate vaccination benefits. The Dutch study probably tends to have some overestimation. The truth lies somewhere in between. My belief is that the Dutch paper is closer to the truth than the (NIAID) paper." He then added: "I find it hard to believe that the flu vaccine doesn't help. What often pushes older patients over the edge is influenza. The statistical study doesn't jibe with my experience."
In all likelihood, the CDC will also endorse the smaller clinical Dutch study because it shows that flu vaccination was effective -in the Netherlands.
What is exceedingly interesting is that in the past:
So how can we protect our elderly population from the flu?
Dr. Simonsen said that her findings suggested that a shift in strategy was indicated and that emphasis should be placed on vaccinating children who spread the flu virus around. She suggested that if 70 percent of schoolchildren were vaccinated, the elderly would be protected without the need for flu shots.
It will be interesting to see how the CDC will be able to convince parents to have their children vaccinated for the purpose of protecting some old people they don’t know - whose own vaccinations do not seem to be effective.
What we do know (7) is that in the fall of 2004, and in spite of a massive propaganda campaign to convince American parents that their children NEEDED a yearly flu vaccination:
As unbelievable as it is, the idea of vaccinating some individuals to protect others – is not new.
Years ago, the CDC recommended vaccinating toddlers - including boys who were at no risk at all- against rubella. The purpose was to protect them from having the disease and exposing their pregnant teachers who may not be immune, possibly because they were never vaccinated. A similar argument was used to encourage chicken pox vaccination of children in the mid nineties.
The vaccination / revaccination of susceptible health care workers against rubella were also obviously recommended - in order to protect pregnant patients. A1981 study revealed that the health workers were not so eager to comply: Only 50% of susceptible clinical employees in a large Medical Center showed up for their booster rubella vaccination and just ONE of eleven rubella-susceptible OB/GYN specialists was revaccinated. (8)
Because the presently-existing “recommendation”has yielded at best, a 30-36% flu vaccination rate among doctors and health care workers, some experts are now suggesting that such practice be REQUIRED.
At a meeting last summer, a vaccine expert stated that extensive data showed that the flu vaccine decreased costs and improved patient safety and public health.
"Voluntary programs don't work," he said. "Mandatory vaccines are the next step in programs that are already in place in most health care settings for workers." (2)
Will such a requirement be approved? Probably
Will doctors, who are aware that the available vaccine may or may not contain the appropriate virus trio, accept to be vaccinated yearly anyway - just to protect others? Probably not
Do stay tuned!
RE: The proposed suggestion that large-scale vaccination of children will protect the elderly population.
The Lancet, in its February 26, 2005 issue will be publishing “Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review” by T Jefferson, S Smith, V Demicheli, A Harnden, A Rivetti, C Di Pietrantonj ( Lancet 2005; 365: 773-80 )
The authors searched the available literature, reviewed 25 studies in detail and listed 40 references. They concluded: “. . . we recorded no convincing evidence that vaccines can reduce mortality, admissions, serious complications, and community transmission of influenza.”
Simonsen, L. et.al. Archives of Internal Medicine, Feb. 14, 2005; vol 165. pp 265-272 ( National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland )
Hak, E. et.al. Archives of Internal Medicine, Feb. 14, 2005; vol 165. pp 274-280. ( Julius Center for Health Sciences and Primary Health Care, University Medical Center Utrecht, Utrecht, Netherlands )
F. Edward Yazbak, MD, FAAP
Falmouth, Massachusetts, 02540 USA