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The Flu Vaccine Saga: The Latest Twist

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The Flu Vaccine Saga: The Latest Twist

http://www.redflagsweekly.com/yazbak/2005_feb25.html

 

Apples and Oranges Too

By Red Flags Columnist, F. Edward Yazbak, MD, FAAP

Falmouth, Massachusetts, USA

tlautstudy

 

The following two statements are frequently heard:

 

* Flu kills some 30,000 Americans a year

* Flu vaccination saves many lives, particularly among the elderly.

 

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:

 

1. For people 85 and older, the mortality rate did not change

throughout the 33 yearly flu seasons

2. In those 65 to 74 years of age, the mortality rate remained the same

between 1980 and 2001

3. The “flu-related mortality” in the elderly remained always less than

10 percent of the total number of winter deaths.

 

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:

 

1. The CDC has systematically rejected the findings of small clinical

autism studies dealing with the MMR-autism connection

2. The CDC has always praised and encouraged large epidemiological

studies, such as the Peltola Group studies (Finland) that were supported by

the vaccine manufacturer.

3. The CDC funded a large epidemiological study in Denmark, though the

findings could hardly be relevant to the situation in the United States

where we administered more vaccines during the first year of life and added

thimerosal to some of them. Danish vaccines were thimerosal-free since 1991.

4. The CDC highly supported and often quoted an epidemiological study

by Kaye that was based on a similar concept as that of the NIAID Flu study.

Kaye had concluded that the MMR vaccination did not cause autism because

the prevalence of autism continued to rise even after a great majority of

children had been vaccinated for years.

 

*****

 

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:

 

* Less than 30% of children at high risk had been vaccinated

* Only half of the number of high-risk children vaccinated during the

previous season (2003-2004) had been revaccinated

* Almost 40% of parents of unvaccinated older children in the “high

risk” category remained unconvinced that vaccination against the flu was

necessary.

 

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!

 

Addendum

 

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.”

 

Now what?

 

------

 

References

 

1. http://www.redflagsweekly.com/conferences/vaccines/2004_oct07.php

2. http://www.acponline.org/journals/news/jul-aug04/vaccinations.htm

3.

http://www.cchealth.org/topics/flu/flu_vaccine_shortage_report_2004_10.php

4.

http://www.nj.com/news/ledger/index.ssf?/base/news-20/1108449730104020.xml

5.

http://webcenter.health.webmd.netscape.com/content/Article/100/105852.htm?printi\

ng=true

6. http://www.medicinenet.com/script/main/art.asp?articlekey=43510

7. http://www.redflagsweekly.com/yazbak/2005_feb17.php

8. Orenstein WA et.al.Rubella vaccine and susceptible hospital

employees. Poor hysician participation. JAMA 1981 Feb 20;245(7):711-3

 

Studies

 

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

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