Classen Immunotherapies, Inc.

6517 Montrose Avenue

Baltimore, MD 21212 U.S.A.

Tel: (410) 377-4549

Fax: (410) 377-8526


J. Barthelow Classen, M.D., M.B.A.


Health Alert: Vaccines Alter Diabetes Risk!


March 25th, 1996: Researchers at Classen Immunotherapies and the University of Utah announce the release of their data in the April issue of Diabetologia (Journal of the European Association for the Study of Diabetes) indicating that immunization alters the risk of developing insulin dependent diabetes (IDDM). The data demonstrates that administration at birth of a single dose of BCG vaccine, used in Europe to prevent tuberculosis, is associated with the prevention of up to 50 cases of diabetes/100,000 children immunized. This is the equivalent of both preventing 20,000 cases of diabetes in the US over 10 years and decreasing diabetes by 25% in many industrialized nations by the age of 15. Classen Immunotherapies' study was derived by reanalyzing an Swedish epidemiology study following over 400,000 immunized and unimmunized children for 12 years.


The data supports Classen Immunotherapies' earlier studies (patent application PCT/US 94/08825) showing that immunization at birth may reduce diabetes while immunization starting after 8 weeks may increase the risk of diabetes, presumably due to the timing of interferon release. The added effect of administering a dose of a vaccine starting at birth, as opposed to starting after 2 months, may result in a 50% reduction in diabetes by age 19. The discovery indicates that vaccine safety studies are dangerously flawed because they are not designed to detect the effect of vaccines on common autoimmune diseases such as insulin dependent diabetes. The data indicates that vaccines may be having an even greater impact on autoimmune diseases than on the serious infectious complications which they are designed to prevent. Classen Immunotherapies is the first to develop proprietary pediatric immunization methods to prevent diabetes.

Classen Immunotherapies' discovery raises strong doubts about the safety of vaccines and indicates that clinical trials are needed immediately to either confirm or disprove the effect of vaccines on diabetes. If confirmed, Classen Immunotherapies discoveries may revolutionize the vaccine field and lead to safer immunization practices. The benefit from changing immunization schedules may exceed the benefit from immunization against polio, due to the high incidence and cost of insulin dependent diabetes. An US citizen's life time risk of developing IDDM may reach 1:100 while the total US cost of this disease may exceed $30 billion annually. Safer vaccines could be on the market in a few years if government officials make vaccine safety a priority.