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Congress Told Military Vaccines Linked to Diabetes, Anthrax Vaccine A Risk.

Washington, October 12, 1999: The Committee on Government Reform of the United States House of Representatives heard testimony today on the subject "Defense Vaccines: Force Protection or False Securities". The committee heard from Dr. J. Barthelow Classen about the increased risk of autoimmunity following immunization in the military and the link between vaccines and diabetes. The Committee on Government Reform chaired by Dan Burton held the meeting in part because of growing concern about the safety of the anthrax vaccine and its ability to induce autoimmune diseases.

Congess heard evidence that vaccination may be doubling the risk of diabetes in military personnel. Data was provided showing an increased risk of insulin diabetes in navy personnel compared to people in the general population. Men drafted into the Swedish military also have twice the risk of diabetes than expected. The anthrax vaccine may cause 1 in every 1,000 recipients to develop insulin dependent and as many as 1 in 200 may develop chronic adverse events from the vaccine.

Extensive research in animals and humans indicates vaccine induced diabetes is common and preventable. Research on childhood vaccines indicates immunization starting in the first month of life is associated with a decreased risk of diabetes while immunization starting after 2 months of life is associated with an increased risk of diabetes. The effect is not limited to a single vaccine but appears to occur with most if not all vaccines.

Classen proposes that public health officials be made accountable for adhering to laws which assure safety of vaccines. Manufacturers should be required to perform long term testing of their vaccines for the development of diabetes and other autoimmune diseases. Recipients and parents need to be informed of data linking vaccines to diabetes and that the age when the first dose is given may affect the risk of diabetes. Development of safer immunization technology should be given priority over the development of new vaccines.

 

Classen's Testimony

 

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

President and Chief Executive Officer

Classen Immunotherapies, Inc.

6517 Montrose Avenue

Baltimore, MD 21212 U.S.A.

Tel: (410) 377-4549 Fax: (410) 377-8526

E-mail: Classen@vaccines.net

 

October 12th, 1999

The Honorable Dan Burton, Chairman

U.S. House of Representatives

Committee on Government Reform

Washington, DC 20515

 

Dear Chairman Burton and committee members,

Thank you for the opportunity to present my views on this important issue. I oppose mandatory anthrax vaccination of military personnel based on safety concerns revealed by my own research. This vaccine has not under gone proper safety testing and along with other vaccines will increase the rate of autoimmune diseases including diabetes in military personnel. The anthrax vaccine will cause medical and financial hardships to its recipients. Currently many do not develop the vaccine induced autoimmune diseases until after leaving the military and are not properly compensated because they do not suspect that their disease is related to their military service or the military denies it is related.

My research involves studying the long term effect of vaccines on autoimmune diseases including diabetes. I began working with the anthrax vaccine over 8 years ago. The product I used was produced by the Michigan Department of Health which is the same product being given to US military personnel. During my studies with the vaccine I did an literature review of the vaccine which included retrieving documents on the vaccine from the FDA as part of the freedom of information act. Enclosed are four letters from the FDA/Public Health Service (Exhibits dated 2/6/1969; 2/10/1969; 9/30/1969; 11/2/1970) which clearly reveal that the anthrax vaccine was approved for marketing without the manufacturer performing a single controlled clinical trial. It is impossible to demonstrate safety and efficacy without performing a clinical trial and the FDA was aware of this but approved the vaccine for marketing anyway. I am not aware of any proper clinical trials with this anthrax vaccine being performed after marketing commenced so strong consideration should be made for removing the vaccine from the market until proper clinical trials are performed.

I studied the ability of the vaccine to stimulate the immune system in ways unrelated to its protective effects against anthrax. These experiments involved using the anthrax vaccine to alter the risk of autoimmune diabetes in the rodents. The data, which has been published in 2 separate papers (Autoimmunity, 24: 137-145, 1996; Autoimmunity, 27(3): 135-139, 1998), showed that even low doses of the anthrax vaccine caused significant stimulation of the immune system. I attribute this strong effect to the many different immunologically active molecules in the vaccine including the aluminum adjuvant. The vaccine is made from an unpurified filtrate from bacteria grown in culture media and thus contains many different molecules which can stimulate the immune system.

My published animal studies indicate that immune stimulatory effect of the anthrax vaccine is additive with other vaccines such as the diphtheria, tetanus and pertussis vaccine. The results of my studies indicated that immunization starting in the first month of life can prevent autoimmune disease including diabetes however immunization starting after 2 months increases the risk both in humans and animals. My work with anthrax vaccine involved giving it in the first month of life however, based on its similarity to other vaccines I have studied, it would be expected to increase the risk of autoimmunity including diabetes when given to adults. This conclusion is supported by a number of human population studies (Infectious Diseases in Clinical Practice, 6: 449-454, 1997). I have discontinued research on using the anthrax vaccine for preventing diabetes based on the risks of giving it to large number of people.

The risk of autoimmunity following immunization of military personnel has been suspected for years but few studies have been performed. Studies were done on Finnish military personnel after receiving vaccines during basic training (Acta Pathol. Microbiol. Scand. 56:478-479,1962; Proceedings of the Society for Experimental Biology and Medicine 124(1):229-233, 1967). The authors showed that many of the people receiving the vaccines developed an autoantibody called rheumatoid factor and were thus at increased risk for developing autoimmune arthritis. The authors state "it is suggested that among apparently healthy persons there are a few with varying degrees of a tendency to form rheumatoid factor in connection with antigen stimulation (Acta Pathol. Microbiol. Scand. 56:479,1962)." Supporting studies have indicated that 0.3% of military recruits develop arthritis acutely post immunization in boot camp however this figure may be low based on the rates of arthritis following single vaccines (Annals of the Rheumatic Diseases 52(12) 843-4, 1993).

I have done some preliminary work in military populations looking for an increased risk of diabetes following immunization, unfortunately the military lacks a sufficient infrastructure to properly evaluate the risk of immunization. Several papers have been published indicating that there is a very high risk of insulin dependent diabetes in the navy (American J. Epidemiology 138:984-987, 1993) and diabetes in the air force (Aviation, Space, and Environmental Medicine 66: 1175-1178). The risk seems to increase with the time in the military. The paper on insulin dependent diabetes in the navy shows that those under 20 who enter the military have a similar rate of diabetes to those of similar age in the general US public (Diabetes Care 16:841-842, 1993) but those in their 30s, and who presumably have been in the military for several years, the rate of diabetes exceeds the age specific rate in the general population. Data from Sweden also suggests that the military vaccines may be leading to an increased risk of diabetes. In Sweden traditionally almost all men, but not women were drafted and received vaccines. The incidence of diabetes in Sweden is about the same in men and women prior to the age of the draft, 18. However, the incidence of diabetes is about twice as high in men then women between the age of 20 and 35 (International Journal of Epidemiology 21:352-358, 1992). By contrast in the US navy between the ages of 17 to 34 white women have a 25% higher rate of insulin dependent diabetes then white men. These data support a causal relationship of vaccines on diabetes in the military.

My data indicates that a single vaccine such as the anthrax vaccine may cause one case of insulin diabetes per 1,000 people immunized (Infectious Diseases in Clinical Practice, 6: 449-454, 1997). The delay between vaccination and the development of diabetes may be delayed 3 to 10 years or more. Immunization of 2.5 million recruits may cause 2,500 people to develop insulin dependent diabetes. Insulin dependent diabetes is just one potential adverse event and the cumulative long term rate of chronic adverse events may be 5 times as high or 1 chronic adverse event per 200 persons immunized.

I am greatly concerned about the safety of the anthrax vaccine and other vaccines. It is clear to me that the government's immunization policies, both the military and civilian, are driven by politics and not by science. I can give numerous examples where employees of the US Public Health Service lack a commitment to medical science and instead appear to be furthering their careers by acting as propaganda officers to support political agendas. In one case I can demonstrate that employees of a foreign government, who were funded and working closely with the US Public Health Service, submitted false data to a major medical journal. The true data indicated the vaccine was dangerous however the false data that was submitted indicated there was no risk. An employee of the NIH who manages large vaccine grants jointly published an misleading letter about the subject with one of these foreign civil servants. As you are aware it is illegal to falsify data from research funded by the US government.

In May employees of the US Public Health Service assured Congressman Mica's subcommittee that the hepatitis B vaccine was safe. Weeks later the US Public Health Service changed its hepatitis B immunization policy because there was too much mercury in the vaccine. It is hard to imagine they did not know a problem existed when they tried to convince Congressman Mica that the vaccine was safe. Employees of the CDC did preliminary studies which supported my data that the hepatitis B vaccine was linked to an increased risk of diabetes. In a follow up study they changed the study design by adding unorthodox mathematical coefficients "fudge factors" to substantially reduce the true risk of diabetes associated with vaccination and now their data would make it appear that the vaccine is safe. Even their new data however indicates those receiving the hepatitis B vaccine starting after 2 months of life may be at a 50% increased risk of diabetes compared to those receiving it at birth. The real tragedy is that our research indicates that technology is available to make vaccines much safer but public health officials are hindering the development of safer technology by denying there are safety problems with existing products. These actions are also preventing individuals from receiving the compensation they are entitled to.

I have several recommendations. First, there is a need to hire a special prosecutor to determine if public health officials are following the laws enacted to ensure vaccines are safe and if public health officials along with manufacturers are misleading the public about the safety of these products. France investigated the actions of its public health officials and found they had not followed the law in ensuring the safety of biological products. After the imprisonment of several public health officials in France, government employees have taken a leadership position in vaccine safety as demonstrated by their discontinuing school age hepatitis B vaccination.

Proper safety studies looking at the long term effects of vaccines on diabetes and other autoimmune diseases need to be done before the anthrax or any other vaccine is promoted for wide spread use. The public needs to be warned about the increased risk of diabetes and other autoimmune diseases associated with vaccines. Private citizens need access to government database so they can perform independent safety studies on vaccines. Successful enactment of these changes will allow improvements in vaccination which could lead to over a 50% reduction in insulin dependent diabetes and other autoimmune diseases.

In closing I am opposed to mass immunization of with the anthrax vaccine because of the inevitable rise in autoimmune diseases as a result of immune stimulation with this vaccine and secondly the questionable efficacy. Thank you for the opportunity to speak.

                                                    Sincerely,

 

                                                    John B Classen, MD

 

Data  Published in Clinical Practice of Alternative Medicine Winter 2001

 

American troops are heavily immunized and we attempted to determine if immunization of military personnel is associated with an increased risk of IDDM.

Medline was searched to locate publications on the incidence of IDDM in civilians aged 18-35 and people in the military in western industrialized nations. Key words used in the Medline search were diabetes, insulin and incidence. References of papers found were used to find additional texts. We prospectively planned to include only papers on Caucasian populations from Western Europe countries, United States, Canada, Australia, and New Zealand because we felt the standards of living and medical care of the Caucasian populations in these countries were similar and our previous studies had revealed an effect in children living in these countries. We limited our search to papers containing incidence data primarily from 1975 to present and containing at least 100 cases of IDDM in the study range.

After we identified countries with data meeting the criteria mentioned above , Internet Search engines including Yahoo and Hotboot were used to determine the status of military conscription in these countries. The name of the country, military, and conscript, were used as key words for the internet search. In the case of Belgium we contacted the library of the military academy by e-mail to find out when the draft was ended.

The mean incidence of IDDM in the control group was determined by a weighted numerical average, using the sum of all the cases of IDDM and the years of follow up from all centers. The incidence of IDDM at any given sex and age group was published for each center . All centers except Sweden published the number of cases of IDDM for each sex and age group. For Sweden the total number of cases for males and females was published for the ages 15-35 and the number of patient year follow up was published. Based on this information and the incidence of IDDM for each age and sex group , an estimate of the number of cases of IDDM was calculated. To be conservative with the Swedish data we used a patient year follow-up size, 1 million, in each group that was in the minimum of the range we expected for each group.

Relative risks and other calculations were made using Epi 6 software (WHO). A 2x2 table was used and included the total number of cases of IDDM and numerator for the control group and the US navy. Uncorrected chi square test was used. Taylor series 95% confidence limits were used. Figures on the relative risk were rounded to the nearest tenth

The computerized search revealed published papers on the incidence of IDDM from the US navy and several Western European countries however we did not find studies from Australia, New Zealand, Canada and several Western European Countries. The incidence of IDDM for adults age 15-35 was available for Sweden (Nystrom et al., 1992), Italy (Muntoni & Songini, 1992) 380(Bruno et al., 1997), Belgium(Vandewalle et al., 1997), Spain (Goday et al., 1992), Norway (Joner & Sovik, 1989), (Joner & Sovik, 1991). All of these countries had laws drafting men but not women. The incidence of IDDM was also published on white men and women who joined the US navy (Gorham et al., 1993). No other studies were found that met the entry criteria.

The data indicates that in the countries where men are drafted but not women the incidence of IDDM is greater in men than women. In those 20 or older the relative risk is 1.68 (1.53 - 1.84) . By contrast in the US military personnel the risk of IDDM is slightly lower in men then women, relative risk 0.8 (0.64-0.97). In these same countries the relative risk of males/females for children 0-14 is about 1.1.

The risk of IDDM is higher in the US military men than conscripted European men age 20-35 relative risk 1.6 (1.45-1.73), but the relative risk is even higher in US Navy women compared to conscripted women 3.4 (2.7-4.26). The incidence of IDDM in young US military personnel, age 17 to 19 is initially in par with the European populations and US civilians %%97(Dokheel, 1993)%% . In male US navy personnel the incidence of IDDM increases gradually over comparable conscripts from European countries with time, relative risk from 1.3 (1.17-1.51) at age 20-24 to 2.5 times (2.01-3.03) at age 30-34. A rise in the relative risk is also seen in US navy women compared to controls, the relative risk rises from 3.0 (2.26-4.07) at age 20-24 to 5.6 (2.9-10.85) at age 30-34. The calculated cumulative increased risk of IDDM in white US military women versus nonconscripted European women from age 20 through 34 is 328 cases/100,000.

There are several findings in this analysis which support an association between vaccination and IDDM. In countries where men, but not women are drafted and are exposed to military immunization, the men have about 1.7 times (1.53-1.84) the risk of developing IDDM as the women. By contrast in the US navy where men and women are both expected to receive military vaccines the incidence of IDDM is less common in men, relative risk 0.8 (0.64-0.97). IDDM is more common in the highly immunized US military men than the less immunized conscripted European men 1.6 (1.45-1.73). However, the risk of IDDM is even more pronounced in US navy women as compared to nonconsripted European women 3.4 (2.7-4.26). The difference in IDDM in the US navy men compared to conscripted men in Europe can be explained by the more extensive use of vaccines in the US military. Sweden's military, for example, during the time frame studied routinely gave the troops the diphtheria -tetanus vaccine but few others (personal communication Herald Heijbel, Infectious disease/vaccine safety expert, Swedish Public Health Department). The US by contrast typically give military personnel many more vaccines.

The incidence of IDDM in the US navy increases with age and years of exposure, further supporting an association between vaccination and IDDM. The incidence of IDDM declines with time in the nonconscripted European women from 10.6 cases/100,000 in the 15-19 age group to 5.9 cases/100,000 in the 30-34 age group, relative risk .56 (0.44-0.72) . By contrast in the heavily immunized navy women the incidence of IDDM increases from 12.6 cases/100,000 in the 17-19 age group to 33.2 cases/100,000 in the 30-34 age group, relative risk 2.63 (1.04-6.69) . A similar though less pronounced effect is seen in men. The in the incidence of IDDM in conscripted European men was fairly constant from 13.5 cases/100,000 in the 15-19 age group to 13.2 in the 30-34 age group, relative risk .97 (.82-1.16). By contrast the incidence of IDDM in the US navy men increases from 12.5 cases/100,000 in the 17-19 age group to 32.4 cases/100,00 in the 30-34 age group, relative risk 2.59 (2.07-3.24). In the US navy men the incidence of IDDM increases gradually over comparable conscripts from European countries with time, relative risk from 1.3 (1.17-1.51) at age 20-24 to 2.5 times (2.01-3.03) at age 30-34 . A rise in the relative risk is also seen in US navy women compared to controls, the relative risk rises from 3.0 (2.26-4.07) at age 20-24 to 5.6 (2.9-10.85). The rise in the women is about as large as in the men but does not reach statistical significance because of the smaller number of women in the navy.

The relative risk of IDDM between men and women in Belgium is particularly interesting. In those 25 or older the relative risk between men and women is about 2.0, similar to many other countries. By contrast the incidence of IDDM in men and women in the 20-24 age group is about the same. This could be explained by the fact that conscription was canceled in Belgium during the study period. A significant number of people in the 20-24 age group may not have served in the military or served a shorten term and thus had less exposure to vaccines. By contrast the older men had been conscripted into the military, received vaccines, and this would explain the increased risk of IDDM in the men compared to women. It is also possible that the incidence of IDDM was similar in men and women between 20-24 because of sampling error or random variation.

The estimation of insulin dependent diabetes in the US navy was made by hospitalization admissions. This system is less accurate and may include cases of type II diabetes however it may have missed case of IDDM that were treated without hospitalization. The authors however do not believe it over estimates the incidence of IDDM. It appears however the estimation is accurate at least in the younger population. The incidence of IDDM in 17-19 year olds is actually less than comparable groups in Europe and to US civilian population (Dokheel, 1993) suggesting the ascertainment in the navy may actually underestimate the cases of IDDM. A study analyzing all cases of diabetes occurring in people 15-34 in Sweden (Arnqvist et al., 1993) indicated that at least 92% of all cases of diabetes diagnosed in people under 30 were classified as type -1 , a result that is in agreement with data from Finland. This data strongly supports the author's contention that the cases in the US navy study were type-1 diabetes.

There are other potential causes of IDDM in military personnel such as travel and exposure to infectious agents in foreign lands. While such factors may affect the outcome of a single study, it is very unlikely they would result in all the associations found in many different studies %%280(Classen & Classen, 1997); 377(Classen & Classen, 1999); 376(Classen & Classen, 1999)%%. Furthermore the majority of conscripts in Europe probably do not travel abroad and thus travel would not explain the difference between men and women in Europe.

Norway has the highest incidence of IDDM and the lowest male/female ratio of IDDM in any European country we studied. This can be explained by the criteria for estimating the incidence of IDDM. The authors state they probably included a number of cases of type II diabetes. Another reason is that Norway, was the only country routinely giving BCG vaccine to adolescents or older individuals at time of the study years. However even with this error, the incidence of IDDM in US navy women is twice as high as women in Norway who are 20 or older.

 

military01.bmp (787510 bytes)

 

Figure 20A: Navy men Vs controls

The incidence of IDDM in highly immunized white men serving in the US navy aged 17-35 was compared to the incidence of IDDM for adult men age 15-35 from several Western European countries. All of the Western European countries had laws drafting men. The incidence of IDDM in young US military personnel, age 17 to 19 is initially in par with the European populations. However, the incidence of IDDM in the highly immunized US navy personnel increases gradually with time compared to comparable (but less highly immunized) conscripts from European countries. The relative risk of IDDM in the US navy increased from 1.3 (1.17-1.51) at age 20-24 to 2.5 times (2.01-3.03) at age 30-34. The in the incidence of IDDM in conscripted European men was fairly constant from 13.5 cases/ 100,000 in the 15-19 age group to 13.2 in the 30-34 age group, relative risk .97 (.82-1.16). By contrast the incidence of IDDM in the highly immunized US navy men increases from 12.5 cases/ 100,000 in the 17-19 age group to 32.4 cases/ 100,00 in the 30-34 age group, relative risk 2.59 (2.07-3.24).

 

military02.bmp (787510 bytes)

 

 

Figure 20B: Navy women Vs controls

The incidence of IDDM in highly immunized white women serving in the US navy aged 17-35 was compared to the incidence in adult women age 15-35 from several Western European countries. None of the Western European countries had laws drafting women. A rise in the relative risk of IDDM is seen in US navy women compared to controls. The relative risk rises from 3.0 (2.26-4.07) at age 20-24 to 5.6 (2.9-10.85) at age 30-34. The incidence of IDDM declines with time in the non conscripted European women from 10.6 cases/ 100,000 in the 15-19 age group to 5.9 cases/ 100,000 in the 30-34 age group, relative risk .56 (0.44-0.72) . By contrast in the heavily immunized navy women the incidence of IDDM increases from 12.6 cases/ 100,000 in the 17-19 age group to 33.2 cases/ 100,000 in the 30-34 age group, relative risk 2.63 (1.04-6.69) .

 

 

 

military03.bmp (787510 bytes)

 

 

Figure 20C: US navy women Vs men

The incidence of IDDM in white men serving in the US navy aged 17-35 was compared to the incidence of IDDM in white women serving in the US navy aged 17-35. in the US military personnel the risk of IDDM is slightly lower in men then women, relative risk 0.8 (0.64-0.97).

 

military04.bmp (787510 bytes)

 

 

Figure 20D: Conscripted men Vs women

 

The incidence of IDDM for conscripted adult men age 15-35 from several Western European countries was compared to the incidence of IDDM in women living in the same Western European countries. All of the Western European countries had laws drafting men but not women. The incidence of IDDM starts about the same in men and women however the incidence in the conscripted men increases relative to the non conscripted women. In those 20 or older the relative risk of IDDM in men versus women is 1.68 (1.53, 1.84) .

 

 

 

Refrences

 

 

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