Dear Members and Friends -
Thanks to David Ayoub, MD in Illinois for the following excellent, well-res earched and footnoted article on the "safety" of flu shots given to pregnan t women.
For those who want to view and print out his article on Tuberculosis and th e TB test, go to this link:
Pregnancy and the Myth of Influenza Vaccination - Is it safe, is it
effective, is it necessary?
On May 28th, 2004 the Advisory Committee on Immunization Practice (ACIP) of
the Centers for Disease Control (CDC) published its annual report (1) on t
heir recommendations for prevention and control of influenza. The fifty-one
page document is intended to provide the most updated scientific basis for
the safe and effective use of influenza vaccination. The purpose of this r
eport is to critically assess the CDC's current recommendations to include
pregnant women amongst those who should receive the influenza vaccine.
|Table 1. List of papers reporting adverse reactions to influenza vacc ination (12)|
|Category of reactions||# papers|
|General adverse reactions||13|
"Case reports and limited studies suggest that pregnancy may increase the risk for serious medical complications of influenza." (1), page 10The mercury concern. In July 1999, as a precautionary measure, the Public H ealth Service (including the CDC and FDA), the American Academy of Pediatri cs, and vaccine manufacturers agreed that thimerosal levels in vaccines sho uld be reduced or eliminated. Contradicting its own policy, the CDC then in creased mercury exposure to the fetus and infant by allowing the inoculatio n of pregnant women and young infants with the mercury-containing influenza vaccine.
Although the complete discussion of the mercury-autism association is beyon d the scope of this paper, some facts are pertinent (see reference 18 an ov erview). Few clinicians realize that most flu vaccines contain 25 microgram s of mercury per dose. Both the EPA and FDA's allowable daily exposure limi ts are 0.1 microgram per kg, meaning that recipients of a flu vaccine must weigh at least 550 pounds to meet federal exposure guidelines. Mercury, whi ch is used as a preservative in the form of thimerosal, is a known neurotox in and crosses both the placental and blood-brain barriers. A growing numbe r of experimental, epidemiological and biochemical research, has unequivoca lly shown that mercury is directly linked to the development of autism spec trum disorders and is significantly toxic to the gastrointestinal, immunolo gical, metabolic and neurobiological systems in children. The developing fe tus would receive a dose of mercury that exceeds the federal limits by seve ral hundred-fold. Furthermore, all federal guidelines are based upon studie s of exposure tolerances in adults, not the more vulnerable fetus. It is in explicable that the CDC is so certain that ethylmercury can be safely injec ted into children or child-bearing women with no concern of harm while the FDA and EPA have warned that oral ingestion of methylmercury can have delet erious effects on the unborn:
"Yet, some fish and shellfish contain higher levels of mercury that may har m an unborn baby or young child's developing nervous system. . . . Therefor e, the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are advising women who may become pregnant, pregnant women, nu rsing mothers, and young children to avoid some types of fish and eat fish and shellfish that are lower in mercury. . . While it is true that the prim ary danger from methylmercury in fish is to the developing nervous system o f the unborn child, it is prudent for nursing mothers and young children no t to eat these fish as well." (13)The CDC and FDA assure clinicians that thimerosal underwent safety testing.
"Prior to its introduction in the 1930's, data were available in several an imal species and humans providing evidence for its safety and effectiveness as a preservative. Since then, thimerosal has a long record of safe and ef fective use preventing bacterial and fungal contamination of vaccines, with no ill effects established other than minor local reactions like redness a nd swelling at the site of injection." (14)
"Prior to its introduction in the 1930's, data were available in several an imal species and humans providing evidence for its safety and effectiveness as a preservative (Powell and Jamieson 1931). Since then, thimerosal has b een the subject of several studies (see Bibliography) and has a long record of safe and effective use preventing bacterial and fungal contamination of vaccines, with no ill effects established other than minor local reactions at the site of injection." (15)
When the reference papers provided by the CDC and FDA are actually reviewed , however, a much different conclusion is reached. The Powell and Jamieson paper of 1931 reported that 88 of 170 rabbits died of mercury poisoning and fatal reactions were reported in rats. (16) Human trials referred to by Po well and Jamieson were more fully discussed in an earlier publication by th e actual physician who treated meningitis patients with intravenous mercury . Dr. K.C. Smithburn (17) reported that 22 patients received thimerosal in a group of meningitis patients whose overall mortality rate was 65%. Unfort unately, the subset that received thimerosal fared worse- none survived (18 ).
Review of all eight additional citations offered by the FDA as evidence of thimerosal's "long safety record", in fact, fall far short of providing any proof of safety.
Looking at the Big Picture
According to Dr. Nancy Cox of the CDC (19), only about 20% of the cases of "flu" are actually caused by the influenza virus. This means that, in theor y, only 20% of all cases of influenza-like illness are preventable by influ enza vaccination and only when there is a perfect antigenic match between t he vaccine strain and the circulating virus. In practice, immunity to influ enza may occur in as few as 50% of vaccinated individuals, even when the st rains match perfectly (1). Indeed, regarding the 2003-04 flu season, the CD C reported "only 3 to 14 percent of those who got vaccinated were protected against the flu" (20).
The CDC and media often cite the statistic that there are nearly 36,000 influenza deaths annually. However, upon closer inspection of data from the National Center for Health Statistics of the CDC, this is a misleading figure . For example, the report of preliminary statistics of death in 2002 (21) shows that only 753 cases of influenza-related deaths were reported compared with 65,231 cases of pneumonia-related deaths. When the CDC compiled the final data, influenza and pneumonia cases are combined, yielding a misleadin g representation of reported influenza cases. Therefore, pneumonia deaths related to factors such as immunosuppression therapy, AIDS, malnutrition and a variety of other predisposing medical conditions are combined with seasonal influenza statistics. The constant broadcast of "36,000 annual influenza deaths" is misleading and unethical by its apparent intended use of fear to promote vaccination.
Furthermore, several published papers contradict the efficacy of influenza vaccination in other high-risk groups. A well-designed, double-blinded, pla cebo-controlled study showed no benefit amongst vaccinated asthmatic childr en in flu prevention (22). Unvaccinated children actually had 33% fewer ast hmatic exacerbations than the influenza-vaccinated group. At least three ot her papers have confirmed these findings.
The ACIP also defended its recent addition of 6-24 month-old infants to the "high-risk" influenza category by citing another study of the Tennessee Me dicaid population. This likewise prevents the generalization of the study f indings to a larger, non-Medicare population. Indeed, a randomized study f rom Japan failed to demonstrate vaccination protection from influenza in he althy, 6-24 month-old children. (23)
Why is the CDC embracing marginal research and unsupported policy? It may come as a surprise to most physicians that the CDC has a built-in co nflict of interest with regards to its dual role in vaccine policy. One lim b of the CDC that oversees vaccine safety has a budget of approximately $30 million while the limb that promotes vaccine usage (ACIP and NIP) has a $1 billion budget. (24)
Furthermore, CDC and FDA policy decisions are made through physician adviso ry panels whose members may have financial relationships, often undisclosed , with the very pharmaceutical industry they serve to regulate. In a congre ssional hearing discussing potential conflicts of interests at the FDA (25) , investigators found that 60% of advisory members who voted to approve the ill-fated rotavirus vaccine had financial ties to the drug maker manufactu ring the same vaccine. The CDC faired no better, with 50% of their members also tied to rotavirus manufacturers. It is little wonder Dr. Paul Offit, o ne such conflicted patent holder of the rotavirus vaccine, recently stated on a CBS broadcast (26) that vaccines were "safer than vitamins". The veter an broadcast journalist failed to reveal that numerous injuries and deaths resulted in part from Dr. Offit's approval of a vaccine that would have eve ntually paid him millions of dollars. Dr. Offit was correct, however, in st ating to Dan Rather that "parents just need to trust experts and sometimes that's a politically hard thing to do". Dr Offit has contributed mightily t o the mounting public distrust of government healthcare officials.
The CDC and the FDA do not have exclusive rights in coddling industry. As r eported in JAMA (27), an investigation of doctors involved in co-authoring forty-four different Clinical Practice Guidelines (CPGs) concluded:
Is all this publicity about the flu vaccine shortage an elaborate sales str ategy? Evidence of such an unthinkable plan exists. The plan is fully disclosed in a slide communiqué entitled "Planning for the 2004-05 Influenza Vaccinat ion Season: A Communication Situation Analysis" (28). The core component of the program, "The Seven-Step Recipe for Generating Interest in, and Demand for, Flu (or any other) Vaccination," appears to be a precise plan to misl ead the general public in order to increase vaccination coverage rates. Lan guage within the presentation reveals their intent to use major news media to send scheduled, fear-based messages in an attempt to convince the unsusp ecting public that not only is the flu shot necessary, but to motivate them to demand it. This will amount to millions of dollars of free advertising for flu vaccine manufacturers. Here are the highlights of this astonishing presentation:
The analyses of available papers cited by ACIP that are specifically design ed to assess the safety and efficacy of influenza vaccination in pregnant w omen are of limited value. Not surprisingly, Medicaid patients seem to be h ospitalized with greater frequency than the non-Medicaid counterparts, but even those of lower socioeconomic status do not have a higher morbidity and mortality when considering maternal, obstetrical and fetal outcomes. Avail able research on non-Medicaid patients failed to demonstrate any benefit fr om immunization. The studies cited by the ACIP in their recent annual repor t on influenza control and prevention fail to support the recently expanded vaccination policy to include pregnant women. Safety testing is notably ab sent or deficient in both scope of adverse reactions assessed and in durati on of follow-up. Considering the rapid growth of autism and other related n eurodevelopmental disorders and mounting number of papers demonstrating the causal relationship to mercury-containing vaccine preservatives, influenza vaccines should not be administered to pregnant women, and perhaps other h igh-risk groups, especially young children.
David M. Ayoub, MD
The Prairie Collaborative for Immunization Safety
1) Prevention and Control of Influenza. Recommendations of the Advisory Com mittee on Immunization Practices (ACIP). MMWR: 53(RR06); 1-40, 2004.
2) Irving WL, et. al., Influenza virus infection in the second and third tr imesters of pregnancy: a clinical and seroepidemiological study. British Jo urnal of Obstetrics and Gynaecology; 107:1282-1289, 2000.
3) Neuzil KM, et. a;., Impact of influenza on acute cardiopulmonary hospita lizations in pregnant women. Am J Epidemiol; 148:1094-102, 1998.
4) Neuzil KM, Reed GW, Mitchel EF, Griffin MR. Influenza morbidity increase s in late pregnancy. Abstracts of the IDSA, 34th Annual Meeting, 1996:48. ( FALL 1996)
5) Black, SB et. al., Effectiveness of the influenza vaccine during pregnan cy in preventing hospitalizations and outpatient visits for respiratory ill ness in pregnant women and their infants. Am J Perinatol; 21(6): 333-339, 2 004.
6) Heinonen OP, et. al., Immunization during pregnancy against poliomyeliti s and influenza in relation to childhood malignancy. Int J Epidemiol: 2; 22 9-35, 1973
7) press release, Institute of Medicine; Oct 22, 2002.
8) Sumaya and Gibbs. J Infect Dis. 1979 Aug; 140(2): 141-6.
9) Deinard and Ogburn. Am J Obstet Gynecol. 1981 Jun 1;140 (3):240-5.
10) Suspension of rotavirus vaccine after reports of intussusception -Unite d States, 1999. MMWR; 53(34): 786-789, 2004.
11) Safranek, et. al., Reassessment of the association between Guillain-Bar re syndrome and receipt of swine influenza vaccine in 1976-1977: results of a two-state study. Expert Neurology Group. Am J Epidem, 133; (9): 940-951, 1991.
16) Powell, HM and Jamieson, WA. Merthiolate as a germicide. Am J Hygiene; 13:296-310, 1931
17) Smithburn, KC. Meningococcic meningitis. A clinical study of one hundre d-forty-four epidemic cases. JAMA; Sept 13, 1930.
18) Mercury in Medicine - Taking Unnecessary risks. A report of the Subcomm ittee on Human Rights and Wellness, Committee on Government Reform, US Hous e of Representatives. May 2003, page 15.
19) B. Fisher, Flu vaccine: Missing the mark. NVIC Special Report, Spring, 2004. http://www.nvic.org
20) MMWR Jan 16, 2004
22) HJ Bueving, et. al., Influenza vaccination in children with asthma. Ran domized double-blind placebo-controlled trial. Am J Resp and Crit Care Med; 169: 488-493, 2004.
23) T Maeda, et. al., Failure of inactivated influenza A vaccine to protect children aged 6-24 months Ped Int; 46:122-125, 2004.
24) Congressman David Weldon, Chicago Illinois. May 28, 2004
25) Conflicts of Interest in Vaccine Policy Making. Majority Staff Report. Committee on Government Reform, U.S. House of Representatives, August 21, 2 000.
26) CBS 60-Minutes, "Saying 'No' to Immunizations" Dan Rather. October 20, 2004. http://www.cbsnews.com/stories/2004/10/20/60II/main650368.shtml
27) Relationships between authors of clinical practice guidelines and the p harmaceutical industry. JAMA; 287: 612-617, 2002.
The CDC must have felt the paper by Neuzil, et. al., was critical in est ablishing its policy to promote vaccinations amongst pregnant women. The re search was first cited in the Spring 1997 MMWR report by ACIP, only a few m onths after it was presented at a national meeting (4) and nearly a year pr ior to its acceptance for publication in the American Journal of Epidemiolo gy. It seems extraordinary that the CDC knew the paper would pass the peer- review process so far in advance of the publication date and risk citing it in this critical healthcare document. Perhaps the addition of one co-autho r, L Simonsen, an employee of the CDC, after the abstract was initially pre sented offered some level of assurance to the ACIP.
 In the April 12, 2002 MMWR, this same statement was followed by the ca veat "However, additional data are needed to confirm the safety of vaccinat ion during pregnancy." This comment was therefore dropped in the CDC's 2004 version of the document, yet no new safety data was cited.
 The topic of the eight papers cited by the FDA: eye drop preparations (4), nasal solutions (1), urine cytology preservatives (1). Two papers act ually offer better alternatives for preserving biological reagents than thi merosal.