May 17, 1999

The Honorable John L. Mica, Chairman

U.S. House of Representatives

Committee on Government Reform

Subcommittee on Criminal Justice, Drug Policy, & Human Resources

Washington, DC 20515


Dear Congressman Mica,

Thank you for the opportunity to discuss my findings on the association between hepatitis B vaccine and insulin dependent diabetes. I want to state that as a physician I have received the hepatitis B vaccine and believe it is a potentially useful tool for reducing the risk of hepatitis in certain high risks groups such as health care workers exposed to blood products. I am however opposed to universal hepatitis B immunization of the general public because the risks are greater than the benefit when the vaccine is given starting after 8 weeks of life.

The US government approves vaccines for marketing and makes universal immunization recommendations based on safety studies which typically follow patients for 30 days or less post immunization. Our research involves studying the risk of autoimmune induced diabetes in people immunized with certain vaccines and in control populations which do not receive the vaccines. Our results show that the risk of immunization with several recommended vaccines including the hepatitis B vaccine are likely to exceed the benefits of immunization in low risk groups and the adverse events may cost US citizens over $10 billion a year as I will discuss later.

Our research has focused on the effect of vaccines on insulin dependent diabetes (diabetes) , an autoimmune disease. An autoimmune disease is a condition where a person's immune system destroys their own tissue. The effect of vaccines on the development of diabetes are expected to reflect the effect of vaccines on other autoimmune diseases. Vaccines are immune stimulants and would thus be expected to increase the risk of autoimmune disease. We found that the incidence of diabetes rose 60% in New Zealand following a massive hepatitis B immunization program (1). The CDC initiated a study to verify our findings. Their preliminary data has been published and shows hepatitis B immunization when given starting after 8 weeks of age is associated with a 90% increase in the risk of diabetes (2), supporting our findings. The study also indicated immunization starting within 21 days of life was associated with a decreased risk of diabetes compared to immunization starting after 8 weeks of life, which also supports our findings (3).

Currently we are attempting to collect additional data on the hepatitis B vaccine as well as data on other vaccines. Our data shows the hemophilus vaccine is likely to cause diabetes (4) and we have confirmed a rise in diabetes in the US (5) and UK (6) following the introduction of the hemophilus vaccine.

The FDA can tract vaccine adverse events through both the VAERS system and the Large Link Database. The VAERS system relies on voluntary reporting of adverse events shortly after immunization. Our data on diabetes shows that vaccine induced diabetes may not occur for 3 or more years following immunization. The Large Link Database is thus an essential tool for monitoring adverse events.

Our data shows the risks of several vaccines are likely to exceed the benefits in low risk groups and cost US citizens over $10 billion a year. Our recently published data (4) shows that for every child that may have a prolonged benefit from the hemophilus vaccine, 2 to 3 children may develop vaccine induced diabetes. There is less accurate data to compare the risks and benefits of the hepatitis B vaccine. However, there are reportedly about 4,000 to 5,00 deaths each year attributed to hepatitis B. If we immunized every child after 8 weeks of life with the hepatitis B vaccine there may be an extra 4,000-5,000 cases of diabetes per year. All told we estimate that there are over 10,000 cases of vaccine induced diabetes in the US each year. On average each case may cost $1 million in lost productivity and medical expenses. The estimated liability cost of the vaccine induced diabetes is over $10 billion per year. The current cumulative liabilities to the US government and to manufacturers could exceed $250 billion.

US law prohibits the marketing of vaccines until they have demonstrated safety. We have proven the hepatitis B and other vaccines do not meet this standard yet they are on the market and children are being forced to receive them. I attribute this to the numerous conflicts of interests in those who are regulating vaccines and setting policy. Let me give you just one example.

I attended a meeting where a senior vaccine executive, and former federal employee, was repeatedly stating to the audience that his company's vaccine was proven to be safe. I discussed with a senior FDA employee who attended the meeting that I was disturbed by how the vaccine executive over stated the safety of his product and how I believed that US law prohibited manufacturers from making false claims about their products. The FDA employee agreed but stated it was so hard to enforce the laws. Later this former FDA employee began working for an vaccine manufacturer. Both his employer and the vaccine executive's employer have a financial interest in the hepatitis B vaccine.

Several changes need to be made to the current policy. Independent researchers representing parents need to have equal access to the large link database as those representing the interests of the established medical community. Manufacturers need to perform long term testing of their vaccines on the development of diabetes and other autoimmune diseases. Parents need to be informed of animal toxicity data (7) and epidemiology data linking vaccines to diabetes and that the age when the first dose is given may affect the risk of diabetes. In addition parents need to be informed that there are insufficient funds to cover expenses of many vaccine adverse events. Development of safer immunization technology should be given priority over the development of new vaccines.

Thank you for the opportunity to present our views and data on this important issue.



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

President and Chief Executive Officer




1. Classen JB. Diabetes epidemic follows hepatitis B immunization program. New Zealand Medical Journal 1996;109:195.

2. DeStefano F, Okoro C, Graffander P, Chen RT. The timing of hepatitis B immunization and risk of insulin dependent diabetes mellitus. Pharmacoepidemiology and Drug Safety 1997;6 S2:S60.

3. Classen DC, Classen JB. The timing of pediatric immunization and the risk of insulin-dependent diabetes mellitus. Infectious Diseases in Clinical Practice 1997;6:449-54.

4. Classen JB, Classen DC. Hemophilus vaccine and increased IDDM, causal relationship likely. BMJ 1999;eBMJ:

5. Dokheel TM. An epidemic of childhood diabetes in the United States. Diabetes Care 1993;16:1606-11.

6. 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;315:713-6.

7. Classen JB. The timing of immunization affects the development of diabetes in rodents. Autoimmunity 1996;24:137-45.