The Flu, Fear and Finance
Steve Tullius, D.C.
“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