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British Medical Journal, 1999;318:193 ( 16 January )

Letters

Public should be told that vaccines may have long term adverse effects

EDITOR: Jefferson's editorial about vaccination and its adverse effects

mentions our research.1 We found that immunisation starting at birth was

associated with a decreased risk of insulin dependent diabetes, while

immunisation starting after age 2 months was associated with an

increased risk of diabetes in both rodents and humans.2 We initiated a

collaboration with Dr Jaakko Tuomilehto to study the effect of

Haemophilus influenzae type b vaccine on the incidence of diabetes.

Roughly 116 000 Finnish children were randomised to receive either four

doses of the vaccine, starting at 3 months of age, or one dose at 24

months of age.3 We calculated the incidence of insulin dependent

diabetes in both groups until age 10 and in a group that did not receive

the vaccinea cohort that included all 128 500 children born in Finland

in the 24 months before the study of the vaccine began.

A conference was held in Bethesda, land, in May 1998 to discuss our

data. At the conference we stated that the data on the vaccine support

our published findings that immunisation starting after the age of 2

months is associated with an increased risk of diabetes. Our analysis is

further supported by a similar rise in diabetes after immunisation with

H influenzae type b vaccine in the United States4 and United Kingdom.5

Furthermore, the increased risk of diabetes in the vaccinated group

exceeds the expected decreased risk of complications of H influenzae

meningitis.

Research into immunisation has been based on the theory that the

benefits of immunisation far outweigh the risks from delayed adverse

events and so long term safety studies do not need to be performed. When

looking at diabetes only one potential chronic adverse event we found

that the rise in the prevalence of diabetes may more than offset the

expected decline in long term complications of H influenzae meningitis.

Thus diabetes induced by vaccine should not be considered a rare

potential adverse event. The incidence of many other chronic

immunological diseases, including asthma, allergies, and immune mediated

cancers, has risen rapidly and may also be linked to immunisation.

We believe that the public should be fully informed that vaccines,

though effective in preventing infections, may have long term adverse

effects. An educated public will probably increasingly demand proper

safety studies before widespread immunisation. We believe that the

outcome of this decision will be the development of safer vaccine

technology.

Barthelow Classen, President. * .

Classen Immunotherapies, 6517 Montrose Avenue, Baltimore, MD 21212, USA

Classen@...

C Classen, Infectious disease physician. * .

Division of Infectious Diseases, LDS Hospital, Salt Lake City, UT, USA

* The methods used in this research are covered by patents owned by

Classen Immunotherapies. Classen holds shares in Classen

Immunotherapies; Classen owns no shares in the company, receives

no funding from it, and has no financial ties to it or to this research.

1.Jefferson T. Vaccination and its adverse effects: real or

perceived. BMJ 1998; 317:

159-160[Full Text]. (18 July.)

2.Classen DC, Classen JB. The timing of pediatric immunization and

the risk of insulin-dependent diabetes mellitus. Infect Dis Clin Pract

1997; 6: 449-454.

3.Eskola J, Kayhty H, Takala AK, Peltola H, Ronnberg PR, Kela E, et

al. A randomized, prospective field trial of a conjugated vaccine in the

protection of infants and young children against invasive Haemophilus

influenzae type b disease. N Engl J Med 1990; 323:

1381-1387[Medline].

4.Dokheel TM. An epidemic of childhood diabetes in the United States.

Diabetes Care 1993; 16: 1606-1611[Medline].

5.Gardner S, Bingley PJ, Sawtell PA, Weeks S, Gale EA. Rising

incidence of insulin dependent diabetes in children under 5 years in

Oxford region: time trend analysis. BMJ 1997; 315: 713-716[Abstract/Full

Text].

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