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The Flu Vaccine and You:

what parents need to know about the new recommendations

By Richard Pitt

We like to think that the advice we get from health organizations and medical professionals is determined solely by unbiased concerns and supported by scientific evidence. However, as most of us are aware, other factors influence decisions regarding health policy. The most obvious of these is the economic and political influence of the drug companies, which has grown considerably in the last 20 years. Another factor is the psychological and social impacts of the events of September 11, 2001, which have helped to create in this country what many are now calling "a culture of fear."

Changing Recommendations

Only a few years ago, the flu vaccine was recommended mainly for elderly people, who were considered to be at risk for flu complications such as pneumonia. In 2002-2003, the flu vaccine was recommended for children who already had diseases such as asthma, and who were also considered more likely to suffer flu complications. By April of this year, both the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) recommended the flu vaccine for all children ages 6 through 23 months, as well as for household contacts and caregivers of all children younger than two years. In the fall of 2004, the flu vaccine will be added to the United States Recommended Childhood and Adolescent Immunization Schedule, which is approved by the Advisory Committee on Immunization Practices of the CDC, the AAP, and the American Academy of Family Physicians.

According to a September 24, 2003, report in USA Today, the CDC was already recommending that everyone get the vaccine in the fall of 2003 (in contrast to the CDC's official published material, which at that time did not recommend that healthy people under age 50 get the vaccine). Due to a rare abundance of the vaccine, it was possible for everybody to be vaccinated. The article stated that the flu kills an average of 36,000 people in the US each year-nearly twice the previous estimate-and that about 20 percent of the population will become infected and 114,000 will be hospitalized.

The routine application of the flu vaccine raises questions that are rarely asked in the medical community or by the public. What has changed in one year? Has a new and virulent flu virus suddenly taken hold? More important, have there been any long-term vaccine trials, especially on children? The answer to these questions is no. The truth is that most children, especially those being breastfed, are at small risk of getting the flu (as opposed to the common cold), and that if they do, they usually recover quickly, without complications.

In addition, injected flu vaccine still contains ethyl mercury in the form of the preservative thimerosal. There is alarming evidence of a possible connection between the mercury found in vaccines and the spiraling rate of autism in children. Because of concern about mercury in all vaccines, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) directed vaccine manufacturers to remove mercury from all childhood vaccines in 1999. In that same year, the American Academy of Pediatrics and the United States Public Health Service (USPS) issued a joint statement calling for the elimination of mercury content in childhood vaccines. Even the Institute of Medicine said, at its July 15, 2001, meeting, that the link between autism and thimerosal was "biologically plausible," and recommended that drug companies remove all mercury from vaccines and over-the-counter drugs. However, several vaccines still contain thimerosal, and neither the AAP nor the CDC will warn citizens to choose thimerosal-free flu vaccines in the fall.

In addition to the potential risks to children from mercury in vaccines, adults should be concerned about the risks they themselves accumulate by taking the vaccine each year. According to Hugh Fudenberg, MD, one of the world's leading immunogeneticists, if an individual had five flu shots between 1970 and 1980 (the years studied), his or her chances of getting Alzheimer's disease are ten times higher than a person who had one, two, or no shots. He explained that mercury and aluminum are found in every flu shot. The gradual buildup of mercury and aluminum in the brain causes cognitive dysfunction.

The Epidemic of 2003

Why was so much attention given to the flu in the winter of 2003-2004? Even a cursory study of the media reveals an explosion of concern that predates the actual epidemic, which everyone was predicting. The first big media interest in the flu was in November 2003, when five Colorado children died of the disease. That month, one could read something about the flu in most newspapers every day-often in a front-page lead story, many of which predicted a flu pandemic. An article in the San Francisco Chronicle (November 28, 2003) quoted experts who stated that a flu epidemic similar to the last serious one, in 1968-1969, which killed an estimated 34,000 in the US, was due to hit sometime soon. The article also cautioned about the possibility of a direct transmission of the flu from poultry to humans. The avian flu, which perhaps originated in China, was apparently not seen before 1997, but recent outbreaks have occurred in Hong Kong, Canada, and the Netherlands. The possibility of a serious flu pandemic is fueling concern in medical circles.1 That will no doubt lead to even more pressure on people to get vaccinated.

On December 6, a headline in the Chronicle read, "Their Vaccine is all Gone, the Two Makers of the Vaccine in the U.S. Say." The paper followed this article with a front-page headline on December 12: "Outbreak Stirs Frenzy in Flu Shots." On December 16, the Chronicle ran a smaller front-page article about new guidelines being implemented by the Catholic Church to help prevent the spread of flu. On December 20, an article on the inside pages told of emergency measures by the CDC to combat the flu.

This is but a small sampling of a single newspaper's flu coverage in the fall of 2003. No wonder so many people rushed to their doctors to get the vaccine, creating huge lines outside many clinics throughout the country.

By December, manufacturers had run out of the vaccine, after mass hysteria had broken out across the country in response to some well-publicized deaths attributed to the disease. The CDC was even thinking of importing more influenza vaccine.2 However, by January 2004, there was virtual silence about the flu, even though we were still in the middle of flu season. The massive media attention had evaporated, leaving us to wonder what had happened. One thing is sure: all the vaccine had been used. The heightened media coverage had been effective in getting people to purchase the vaccine. Questions remain, however: Was the vaccine effective? Was the flu actually more virulent than in previous years?

So far, the evidence suggests that the vaccine was not very effective, and that the outbreak was no worse than in most other years. While other deaths were attributed to the flu, there is no evidence that any more people died in the 2003-2004 flu season than in previous seasons. Also, when someone dies of a complication of a disease such as the flu, it is as much a reflection of the general weakness of the person's immune system and overall health as it is an indication of the virus's virulence. In addition, it is often not the flu itself that actually kills a person, but secondary bacterial infections, such as pneumonia, to which some persons are more susceptible.3

A 2001 report in the British medical journal The Lancet stated that the flu virus itself may not be the reason that so many die of infectious disease during winter.4 Another virus, commonly known as RSV, has been found to be more prevalent than the influenza A and B strains.

Effects of the Vaccine

Although one can read differing opinions of the flu vaccine's efficacy, it has been admitted, by the CDC and other experts, that the vaccine did not work well in the 2003-2004 season because the strain of flu virus differed from the strain from which the vaccine had been prepared.5, 6 Historically, the flu vaccine has been made from cultures of viruses taken in Asia from migrating ducks. (Over the years, an association has been established between bird and pig viruses and the following year's epidemics of human flu.) The vaccine is then prepared from the body fluids of chick embryos inoculated with a specific type or types of influenza virus. The strains of flu virus in the vaccine are inactivated with formaldehyde and preserved with thimerosal, the mercury derivative. The vaccine protects against only the three specific viral strains of flu included in any given year's vaccine.

Because the influenza vaccine is grown on hen eggs, the AAP recommends that children with actual or suspected allergic reactions to chicken or egg protein not be given the flu vaccine unless they undergo desensitization.

Given the unpredictability of matching each year's flu vaccine to the actual strain of flu virus that will later spread among the human population, it is highly questionable whether the vaccine is anything more than marginally effective. The CDC report on the 1994-1995 flu season stated that 87 percent of influenza A virus samples and 76 percent of influenza B virus samples were not similar to that year's vaccine.7 Although researchers today are more accurate in matching vaccine to virus, it is still a hit-or-miss affair that makes the vaccine's efficacy inherently unpredictable. According to "Recommendations for Influenza Immunization of Children," an AAP policy statement, "Protective efficacy against influenza illness confirmed by positive culture varies between 30 percent and 95 percent." 8-12

Risks of the Vaccine

The very people who traditionally have been encouraged to get the flu vaccine-the elderly and the immunocompromised (those with weak or impaired immune systems)-are those most likely to suffer from acute consequences of the vaccine's side effects. The CDC lists these effects as fever, fatigue, muscle aches, and headache. These symptoms, which sound remarkably similar to flu symptoms, are exactly what many people experience after taking the vaccine. More serious side effects have also been noted that specifically link the flu vaccine to Guillain-Barré syndrome (GBS), an autoimmune nervous-system reaction characterized by unstable gait and loss of sensation and muscle control.13

In 1976, the US government mounted a mass vaccination program in which 45 million Americans received the swine flu vaccine. Statistical studies have confirmed a causal relationship between the vaccine and GBS. During that year, the rate of GBS in Ohio was 13.3 per 1,000,000 in vaccine recipients, compared to 2.6 per 1,000,000 in nonrecipients.14 These statistics left doctors reluctant to administer the flu vaccine, and diminished the trust that the public had in the flu vaccine campaign. More recently, an increased risk for GBS occurred in patients during the six weeks following the administration of flu vaccine in the 1992-1993 and 1993-1994 flu seasons.15

Since 2001, the CDC has recommended that all pregnant women receive the flu vaccine in their second or third trimester.16 This recommendation has been made despite the fact that the vaccine remains a Category C drug (one for which the risk to pregnant women and their fetuses is unknown). The vaccine's mercury content is a major factor in its potential impact on fetal brain development, but no adequate studies have been conducted to monitor the flu vaccine's safety for mother or fetus. According to the CDC, two groups are most vulnerable to thimerosal, or ethyl mercury: the fetus, and children ages 14 or younger.17 A 1999 article in the American Journal of Epidemiology stated in regard to ingested mercury, "The greatest susceptibility to methyl mercury neurotoxicity occurs during late gestation."18 Even the CDC Advisory Committee on Immunization Practices, despite its own recommendation, states, "additional data are needed to confirm the safety of vaccination during pregnancy."19

The FluMist Vaccine

The latest development in the flu vaccine campaign is FluMist, an intranasal vaccine administered via a spray directly into the recipient's nose. MedImmune/Wyeth, the manufacturer of FluMist, announced in August 2003 that it had signed an agreement with Wal-Mart, the world's largest retailer, making the vaccine available in all Wal-Mart pharmacies.20 An intense, $25 million advertising campaign in support of FluMist was launched in the last few months of 2003. Each FluMist dose costs around $70 retail, which MedImmune hoped would push its annual revenues to more than $1 billion.

This did not happen, despite the frenzy for flu vaccine this past winter. Although many insurance companies eventually agreed to cover the cost of FluMist after the traditional flu vaccine began to run out in November and December 2003, MedImmune/Wyeth reported FluMist sales of between $35 and $55 million, instead of the $120 to $140 million expected.21 As a result, MedImmune/Wyeth has donated 250,000 doses of FluMist to the CDC.22 It will be interesting to see how MedImmune/Wyeth pitches the vaccine to the public in 2004-2005, when fear of a pandemic will no doubt again hit the media.

The FluMist vaccine contains live (attenuated) influenza viruses that replicate themselves in the recipient's nasopharynx (nose and throat). A live vaccine carries specific risks that must be considered. Researchers have documented some of these risks, including the possibility of enhanced replication of the attenuated virus in individuals with compromised immune systems, and the possibility of bacterial superinfection (a reinfection or second infection) if the replicating live virus disrupts nasal membranes.23

In addition, the live virus can be spread from the vaccine recipient to other, nonvaccinated people for up to 21 days. A warning on the FluMist package insert states, "FluMist recipients should avoid close contact with immunocompromised individuals for at least 21 days." Therefore, those living with or coming into contact with people who have compromised immune systems should not take the FluMist vaccine. However, it is difficult to see how such contacts can be avoided. When you consider the numbers of people in the country whose immune systems have been compromised by conditions ranging from AIDS to cancer, allergies, and dependence on corticosteroid drugs, the list of vulnerable people becomes very long.

According to the FluMist package insert, a randomized, double-blind trial in healthy children 1 through 17 years of age was conducted through the Northern California Kaiser-Permanente Health Maintenance Organization to assess the rate of medically attended events within 42 days of vaccination. In an unplanned retrospective analysis, a statistically significant increase in asthma or reactive airway disease was observed for children 12 to 59 months of age after the first dose. Because of this finding, FluMist is currently not licensed by the FDA for children younger than five. The insert admits that further evaluation of safety data in this age group is needed.

The FluMist vaccine can be obtained only through a doctor, and, because of the risk of contagion due to this use of a live virus, can be administered only by a doctor or trained health professional. Children under 12 can be vaccinated only in a doctor's office or clinic. It is possible that the live virus used in FluMist could trigger the very flu epidemic the vaccine is intended to prevent, as a community's older and weaker members are the very ones who would be more susceptible. In short, the cure could be worse than the disease. By introducing a live vaccine into the bodies of thousands of people, FluMist could easily spread the virus to others and create a flu outbreak.

The AAP does not recommend the live flu vaccine for the following people: children younger than five, those with a history of allergic reaction to egg or chicken protein, and pregnant women. In addition, individuals receiving salicylates, or those with known or suspected immune deficiency, history of GBS, reactive airway disease or asthma, chronic pulmonary disorders or cardiac disorders, chronic metabolic disease, or renal dysfunction should not receive the live virus vaccine.

The FluMist vaccine is created using chicken kidney cells grown in "specific pathogen free eggs." However, there is a risk of contaminated avian (bird) retroviruses crossing over into human beings, with unknown consequences. Viruses crossing the species barrier has been an issue of serious concern for some time; other vaccines made with animal organs have been found to contain animal viruses.24 In fact, a vaccine is the most immediate way to transmit a virus from one species to another, breaching the species barrier that normally prevents cross-contamination. Cross-species transformations of viruses may be a factor in understanding the evolution of other diseases, such as AIDS. This concern has already been hotly disputed within the AIDS and medical communities.25, 26

The possible risks of the FluMist vaccine have yet to be seen. However, they seem grave enough to warrant serious consideration before FluMist is put into general use, especially considering the limited risks of the disease it is intended to prevent, and the historical ineffectiveness of flu vaccines.

Increasing Fear and its Exploitation

In the last five years, the pressure on people to take a flu vaccine has increased greatly. Only three years ago, flu vaccines were recommended only for elderly people and those with compromised immunities. Flu vaccines were next recommended for young children with problems such as asthma, then healthy children and adults, and then, in 2003, the entire US population. If you called Walgreens in November 2003, the first thing the recorded message told you was when you could get your flu vaccine. Costco put up signs at store entrances telling shoppers where they could get the vaccine. Employers advised their employees to get the vaccine to reduce the number of sick days taken; nurses actually came to some offices to administer the vaccine. Health insurance companies sent materials to their clients asking them to get vaccinated, especially people they considered to be at risk.

If all this activity reflected the latest in medical knowledge and research, you might imagine that it would be replicated in other countries. It is not. Flu phobia is unique to the US; European countries do not advocate blanket flu-vaccine policies. Such disparate health policies in different countries make one question the scientific rationale for such a massive health policy.

In the US, the influence of drug companies, with their connections to health-policy organizations such as the CDC and the FDA, is having a profound impact on health policy. The population is already susceptible to the influence of "experts" in the shadow of 9/11, and the fear of biological warfare can be exploited for economic and political reasons.

What we saw during the winter of 2003-2004 was an explosion of fear fueled by the media's insatiable desire for sensational news, a country already in the grips of post-9/11 fear, and a medical industry caught up in this fear and driven by economic and political agendas. It has been frightening to see how easily people can be convinced of the dangers of the flu, with precious little questioning by media and medical "experts."

NOTES

1. Editorial desk, "The Spread of Avian Influenza," New York Times (30 January 2004). Abstract: Editorial urges immediate infusion of Western expertise and money to prevent spread of avian influenza in Southeast Asia; expresses concern that virus will mutate and become transmittable from human to human rather than just from bird to bird and from bird to human; says most urgent task is to destroy all infected birds, compensating farmers for their losses.

2. Lawrence K. Altman, "US Considers Importing Influenza Vaccine," New York Times (10 Decem-ber 2003).

3. Centers for Disease Control, www.cdc.gov/flu/keyfacts.htm.

4. Eric Simoes, "Overlap between Respiratory Syncytial Virus (RSV) Infection and Influenza," The Lancet 358, no. 9291 (27 October 2001).

5. "Flu Shot Unable to Combat Virus Strain," http://abcnews.go.com/wire/Living/ap20031215_870.html.

6. "Panel of Vaccine Experts Fear Flu Shot May Not Work Well in Combating This Year's Virus Strain," www.nvic.org/PressReleases/prfluvac cine.htm.

7. Randall Neustaedter, The Vaccine Guide (Berkeley, CA: North Atlantic Books, 2003): 159.

8. W. C. Gruber, L. H. Taber, W. P. Glezen et al., "Live Attenuated and Inactivated Influenza Vaccine in School-Age Children," Am J Dis Child 144 (1990): 595-600.

9. T. Heikkinen, O. Ruuskanen, M. Waris et al., "Influenza Vaccination in the Prevention of Acute Otitis Media in Children," Am J Dis Child 145 (1991): 445-448.

10. E. S. Hurwitz, M. Haber, A. Chang et al., "Studies of the 1996-1997 Inactivated Influenza Vaccine among Children Attending Day Care: Immunologic Response, Protection against Infection, and Clinical Effectiveness," J Infect Dis 182 (2000): 1218-1221.

11. K. M. Neuzil, W. D. Dupont, P. F. Wright et al., "Efficacy of Inactivated and Cold-Adapted Vaccines against Influenza A Infection, 1985 to 1990: The Pediatric Experience," Pediatric Infect Dis J 20 (2001): 733-740.

12. A. Hoberman, D. P. Greenberg, J. L. Paradise et al., "Effectiveness of Inactivated Influenza Vaccine in Preventing Acute Otitis Media in Young Children: A Randomized Controlled Trial," JAMA 290 (2003): 1608-1616.

13. T. Lasky et al., "Guillain-Barré Syndrome and the 1992-1993 and 1993-1994 Influenza Vaccines," New England Journal of Medicine 339 (1998): 1797-1802.

14. J. S. Marks and T. J. Halpin, "Guillain-Barré Syndrome in Recipients of a New Jersey Influenza Vaccine," JAMA 243, no. 42 (1980): 2490-2494.

15. See Note 13.

16. Centers for Disease Control, www.cdc.gov/nip/publications/VIS/vis-flu.txt.

17. Centers for Disease Control, www.cdc.gov/nip/vacsafe/concerns/thimerosal/faqs-thi merosal.htm.

18. P. Grandjean et al., "Methylmercury Exposure Biomarkers as Indicators of Neurotoxicity in Children Aged 7 Years," American Journal of Epidemiology 150, no. 3 (1999): 301-305.

19. Centers for Disease Control, "Prevention and Control of Influenza: Recommendatons of the Advisory Committee on Immunization Practices (ACIP)" MMWR (b) (RR04) (2001): 1-46.

20. "FluMist Available in Pharmacies This Fall," Dow Jones Business News (12 September 2003): http://biz.yahoo.com/djus/030910/00170000112.html.

21. "FluMist Vaccine Donated to Health Agencies," Reuters report (21 January 2004): http://biz.yahooo.com/rec/040121/health_flu_vac cine_1.html.

22. Ibid.

23. K. Subbarao, "As Good As the Real Thing," Journal of Pediatrics 136 (2000): 139-141.

24. S. G. Fisher et al., "Cancer Risk Associated with Simian Virus 40 Contaminated Polio Vaccine," Anticancer Research 19, no. 3B (1999): 2173-2180.

25. M. Essex and P. Kanki, "The Origins of the AIDS Virus," Scientific American 259 (1988): 64-71.

26. B. F. Elswood and R. B. Stricker, "Polio Vaccines and the Origin of AIDS," Medical Hypotheses 42 (1994): 347-354.

Article first published in Mothering Magazine - August 2004

For more information about vaccines, see the following article in a past issue of Mothering: "Show Us the Science," no. 105. www.mothering.com


Richard Pitt is a practitioner of homeopathic medicine in San Francisco. He is director of the Pacific Academy of Homeopathy, which offers a three-year professional training program in homeopathy. He also serves on the board of the California Health Freedom Coalition, the California Homeopathic Medical Society, and the Council for Homeopathic Certification.

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