The Flu, Fear & Finance
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“Getting a flu vaccine is the single best way to prevent the flu.” While this statement comes directly from the Center for
Disease Control (CDC) website, recent research would suggest that the statement is unfounded. An independent
analysis of worldwide vaccine studies by the internationally renowned Cochrane Collaboration, published in the British
Medical Journal in 2006, concluded that there is little scientific proof that the influenza vaccine is safe or effective for
children and adults. The report concluded that too few clinical trials have been conducted to prove vaccine safety, and
current evidence indicates that use of the vaccine in children under 2 years had the same efficacy as placebo. In
healthy people under 65 vaccination did not affect hospital stay, time off work, or death from influenza and its
complications. [1]
Tom Jefferson, MD, and colleagues at the Cochrane Collaboration, also wrote to The Lancet reporting that the safety
of influenza vaccines given to babies and children is unknown. Incredibly, most of the trials they reviewed were not
designed to assess serious adverse reactions. Given that the CDC currently recommends flu vaccines for all healthy
children older than 6 months, this news is extremely disturbing.
If you go to the CDC website’s main flu page you will find they claim the flu is responsible for 36,000 deaths per year.
[2] However, if you go to CDC’s more comprehensive National Vital Statistics Report you will find that only 257 people
died of the flu in 2001 and 753 in 2002. [3]
A search of the Vaccine Adverse Event Reporting System (VAERS), a cooperative program of the CDC and the Food
and Drug Administration (FDA) collecting information about adverse events that occur after the administration of U.S.-
licensed vaccines, reveals 395 deaths between 1990 and August of this year following administration of the flu
vaccine. Forty-four of those deaths were in children 4 years old and younger. [4]
VAERS is a passive surveillance system and depends on voluntary reporting of serious health problems following
vaccination, even though safety provisions in the National Childhood Vaccine Injury Act of 1986 mandate that health
care providers report vaccine adverse events. There have been estimates that fewer than 10 percent, even as low as
1 to 4%, of adverse events which occur after prescription drug or vaccine use are ever reported to government
adverse event reporting systems. [5] [6] [7] [8]
According to the CDC 2004 National Vital Statistics Report, there were 18 deaths from the flu in children age 0-4
years. If those studies are indeed correct then the actual number of deaths in children age 0-4 years following flu
vaccine administration could be as high as 25 per year and 223 vaccine associated deaths per year in all age groups.
If that weren’t enough reason to avoid the flu vaccine, influenza virus strains mutate, necessitating a new vaccine each
year. Every year, the World Health Organization predicts which strains of the virus are most likely to be circulating the
following year so vaccine manufacturers can produce vaccines for administration that fall. In the 1994-1995 flu season,
the CDC reported that 43% of isolated influenza samples for the predominant virus were not similar to that in the
vaccine. Likewise, for another virus 87% of samples were not similar to that in the vaccine. For yet another, 76% of
isolated samples were not similar to that in the vaccine. [9].. During the 1992-1993 flu season 84% of the isolated
influenza samples for the predominant virus were not similar to that in the vaccine. [10]
Although influenza is associated with more disease, hospitalization, and death in "at risk" populations, no adequate
controlled studies exist which prove that influenza vaccine reduces the incidence of influenza in these groups. [11]
With all this information showing minimal effectiveness and definite risks, why does the CDC recommend we all get our
flu shots?
According to Glen Nowak, Ph.D., associate director for Communications of the CDC’s National Immunization Program,
the best “recipe” for a successful influenza season is for “medical experts and public health authorities to publicly (e.
g., via media) state concern and alarm (and predict dire outcomes)–and urge influenza vaccination.” This should
produce “significant media interest and attention” and “framing of the flu season in terms that motivate behavior (e.g.,
as ‘very severe,’ ‘more severe than last or past years,’ ‘deadly’).” [12] Prime example of the type of fear-mongering,
use of the media and manipulation of the general public that goes on in the CDC.
There are also severe breaches of conflicts of interest among the federal vaccine policy-makers. In August 1999, the
U.S. House of Representatives Committee on Government Reform initiated an investigation into federal vaccine policy
that focused on possible conflicts of interest on the part of federal policy-makers. The committee released a report
focusing on two influential advisory committees utilized by federal regulators to provide expert advice on vaccine
policy: the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the CDC’s Advisory
Committee on Immunizations Practices (ACIP). The VRBPAC advises the FDA on the licensing of new vaccines, and
the ACIP advises the CDC on guidelines to be issued to doctors and the states for the appropriate use of vaccines.
Members of the advisory committees are required to disclose any financial conflicts of interest and recluse themselves
from participating in decisions in which they have an interest. The committee’s investigation determined that conflict of
interest rules employed by the FDA and the CDC have been weak, enforcement has been lax, and advisory committee
members with substantial ties to pharmaceutical companies have been given waivers to participate in committee
proceedings. [13] Among the specific problems identified in the House committee staff report: The CDC routinely
grants waivers from conflict of interest rules to every member of its advisory committee. The chairman of the CDC’s
advisory committee owned 600 shares of stock in Merck, a pharmaceutical company with an active vaccine division.
Members of the CDC’s advisory committee often fill out incomplete financial disclosure statements, and are not
required to provide the missing information by CDC ethics officials. Four out of eight CDC advisory committee
members who voted to approve guidelines for the rotavirus vaccine in June 1998 had financial ties to pharmaceutical
companies that were developing different versions of the vaccine. 3 out of 5 FDA advisory committee members who
voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were
developing different versions of the vaccine. [13]
Conflicts of interest abound in both the FDA and CDC and there is an open door between the pharmaceutical
corporations and those organizations, meaning researchers and consultants often go back and forth between working
for the pharmaceutical industry and the CDC and FDA.
According to the 2003 Chiron annual report, the company made $332.4 million in sales on flu vaccine alone and had a
53% gross profit. Perhaps this has something to do with increasing media attention, commercials and
recommendations for everyone age 6 months old and older to receive a flu vaccine.
With little proof of effectiveness and safety, questionable marketing techniques by the CDC and rampant conflicts of
interest between those making vaccine policy and the pharmaceutical companies bringing in millions of taxpayers
money, perhaps it's time to rethink the perceived need for a flu vaccine this year or in the future.
References
1. BMJ 2006;333:912-915 (28 October) "Influenza vaccination: policy versus evidence"
2. http://www.cdc.gov/flu/keyfacts.htm (accessed October 2007)
3. http://www.cdc.gov/nchs/data/nvsr/nvsr52/nvsr52_13.pdf (accessed October 2007)
4. http://www.medalerts.org/ (accessed October 2007)
5. Scott, HD, Rosenbaum SE, et al. Rhode Island physicians’ recognition and reporting of adverse drug
reactions. RI Med J 1987; 70:311-316.
6. Rosenthal, S, Chen, R. The reporting sensitivities of two passive surveillance systems for vaccine adverse
events. Am J Public Health 1995; 85:1706-9.
7. Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. John’s Hopkins
Bloomburg School of Public Health. www.vaccinesafety.edu/VAERS.htm
8. Food and Drug Administration, Center for Drug Evaluation and Research. The clinical impact of adverse event
reporting. MedWatch. October 1996.
9. Update: influenza activity-worldwide, 1995. MMWR 9/9/95; 44(35): 644-45, 651-52.
10. Update: influenza activity-United States and worldwide, 1993. MMWR 10/1/93; 42(38): 752-55.
11. Fiebach, N, Beckett, W. prevention of respiratory infections in adults: influenza and pneumococcal vaccines.
Arch Intern Med. 1994: 154: 2545-57.
12. Nowak, G, “Planning for the 2004-05 Influenza Vaccination Season: A Communication Situation Analysis. http:
//www.ama-assn.org/ama1/pub/upload/mm/36/2004_flu_nowak.pdf (slides 27-30)
13. Conflicts of Interest in Vaccine Policy Making Majority Staff Report, Committee on Government Reform, U.S.
House of Representatives, June 15, 2000
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Steve Tullius, D.C.
