BMJ, Jan 16, 1999;318(7177):193
"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."
Influenza vaccination: policy versus evidence
BMJ, Oct 28, 2006; 333(7574):912-915
"The large gap between policy and what the data tell us (when rigorously assembled and evaluated) is surprising. The reasons for this situation are not clear and may be complex. The starting point is the potential confusion between influenza and influenza-like illness, when any case of illness resembling influenza is seen as real influenza, especially during peak periods of activity. Some surveillance systems report cases of influenza-like illness as influenza without further explanation. This confusion leads to a gross overestimation of the impact of influenza, unrealistic expectations of the performance of vaccines, and spurious certainty of our ability to predict viral circulation and impact. The consequences are seen in the impractical advice given by public bodies on thresholds of the incidence of influenza-like illness at which influenza specific interventions (antivirals) should be used."
"Another reason may be “availability creep.” In their efforts to deal with, or be seen to deal with, policy makers favour intervention with what is available—registered influenza vaccines. A similar philosophy is the “we have to make decisions and cannot wait to have perfect data” approach. This attitude may have an altruistic basis but has two important consequences. Firstly, it uses up resources that could be invested in a proper evaluation of influenza vaccines or on other health interventions of proven effectiveness. Secondly, the inception of a vaccination campaign seems to preclude the assessment of a vaccine through placebo controlled randomised trials on ethical grounds. Far from being unethical, however, such trials are desperately needed and we should invest in them without delay. A further consequence is reliance on non-randomised studies once the campaign is under way. It is debatable whether these can contribute to our understanding of the effectiveness of vaccines. Ultimately non-randomised designs cannot answer questions on the effects of influenza vaccines."
What, in Fact, Is the Evidence That Vaccinating Healthcare Workers against Seasonal Influenza Protects Their Patients? A Critical Review
Int J Family Med. 2012; 2012:205464
"The studies aiming to prove the widespread belief that healthcare worker vaccination decreases patient morbidity and mortality are heavily flawed and the recommendations for vaccination biased. No reliable published evidence shows that healthcare workers' vaccination has substantial benefit for their patients—not in reducing patient morbidity or mortality and not even in increasing patient vaccination rates. Conclusion. The arguments for uniform healthcare worker influenza vaccination are not supported by existing literature. The decision whether to get vaccinated should, except possibly in extreme situations, be that of the individual healthcare worker, without legal, institutional, or peer coercion."
Association between type 1 diabetes and Haemophilus influenzae type b vaccination: birth cohort study
BMJ 1999;318:1169
"It is understandable that public health officials want to avoid scaring the public however they risk depriving damaged children of compensation. Their denial of safety concerns are likely to lead to an
eroding of public confidence especially since they may be able to avoid the problem of vaccine induced diabetes by starting vaccination a few weeks earlier"
Dynamic model of vaccination behavior
The following are comments that are part of expert congressional testimony regarding vaccine policy and safety, submitted by J. Barthelow Classen, M.D., M.B.A.
"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 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."
"The studies aiming to prove the widespread belief that healthcare worker vaccination decreases patient morbidity and mortality are heavily flawed and the recommendations for vaccination biased. No reliable published evidence shows that healthcare workers' vaccination has substantial benefit for their patients—not in reducing patient morbidity or mortality and not even in increasing patient vaccination rates. Conclusion. The arguments for uniform healthcare worker influenza vaccination are not supported by existing literature. The decision whether to get vaccinated should, except possibly in extreme situations, be that of the individual healthcare worker, without legal, institutional, or peer coercion."
Indian J Med Ethics. 2012 Apr-Jun;9(2):114-7.
"It was hoped that following polio eradication, immunisation could be stopped. However the synthesis of polio virus in 2002, made eradication impossible. It is argued that getting poor countries to expend their scarce resources on an impossible dream over the last 10 years was unethical. Furthermore, while India has been polio-free for a year, there has been a huge increase in non-polio acute flaccid paralysis (NPAFP). In 2011, there were an extra 47,500 new cases of NPAFP. Clinically indistinguishable from polio paralysis but twice as deadly, the incidence of NPAFP was directly proportional to doses of oral polio received. Though this data was collected within the polio surveillance system, it was not investigated. The principle of primum-non-nocere was violated. The authors suggest that the huge bill of US$ 8 billion spent on the programme, is a small sum to pay if the world learns to be wary of such vertical programmes in the future."Association between type 1 diabetes and Haemophilus influenzae type b vaccination: birth cohort study
BMJ 1999;318:1169
"It is understandable that public health officials want to avoid scaring the public however they risk depriving damaged children of compensation. Their denial of safety concerns are likely to lead to an
eroding of public confidence especially since they may be able to avoid the problem of vaccine induced diabetes by starting vaccination a few weeks earlier"
Dynamic model of vaccination behavior
The following are comments that are part of expert congressional testimony regarding vaccine policy and safety, submitted by J. Barthelow Classen, M.D., M.B.A.
"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 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."
