İ Diabetes Health 12/01/2000
Do Infant Vaccines Cause Diabetes?
Can You Sue if They Do?
CDC and NIH Question Immunologistıs Latest Claims Lone researcher J. Barthelow Classen, MD, MBA, is still clinging to his nine-year-old theory that childhood vaccines are the largest cause of type 1 diabetes. The theory, which Classen claims has kept him living in poverty for nine years, has been convincing enough to lead researchers around the world to conduct studies of their own, all of which dispute the findings of Classen. On September 19, the U.S. Centers for Disease Control and Prevention (CDC), at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAACC) in Toronto, proclaimed in its latest study there was no increased risk of diabetes associated with the hepatitis B and hemophilus vaccine, regardless of the age at first vaccination. In reviewing the CDCıs data, Classen arrives at a different conclusion. He says the CDCıs data presented at the ICAAC confirms his data that childhood vaccines are the largest cause of type 1 diabetes. Is Classen Credible? Frank Vinicor, MD, MPH, director of the division of diabetes translation at the CDC, says there have been two international meetings, one at Johns Hopkins and one at the National Institutes of Health (NIH), specifically addressing the questions that Classen raises. According to Vinicor, both health organizations felt there was not sufficient evidence for Classen to support his position. ³Further, the Cochrane Center, the evidence-based institute in the United Kingdomı, has issued a publication disputing the existence of any evidence to support Dr. Classenıs immunization theory for type 1 diabetes,² says Vinicor. Compensation for Vaccine-induced Victims Classen is now saying people with diabetes can seek legal compensation for their vaccine-induced injuries. Lawyers attending the September International Public Conference on Vaccination who reviewed Classenıs data are advising people with diabetes possibly injured by vaccines to seek legal counsel at once. The United States and other governments provide compensation for vaccine-induced injuries. Cliff Shoemaker of Shoemaker and Horn in Vienna, Virginia, is one attorney who is filing such claims on behalf of people with diabetes. Shoemaker specializes in vaccine-injury compensation and says the statute of limitations for people with diabetes seeking legal compensation is three years from the onset of symptoms for claims under the Vaccine Injury Compensation Program (VICP). The VICP is administered by the Department of Health and Human Services (DHHS), under which compensation may be paid for a vaccine-related injury or death. Michael R. Hugo, Esq., an attorney who also handles vaccine-injury cases for Hugo and Pollack, LLP of Boston, says the statute of limitations for people with diabetes seeking financial compensation for their injuries is completely a matter of state law. ³In most states, it is three years from the date of discovery that someone was harmed by a vaccine,² says Hugo. ³Also, in most states, there is a period of time where the statute of limitations does not even begin to run until the child reaches the age of majority for that state.² Shoemaker agrees with Hugo that statutes of limitation for states are quite variable. He adds there are many injuries a person with diabetes can suffer, ³and suffering any of it qualifies one for compensation.³ In order for a type 1 to seek compensation for a vaccine-related injury, according to Hugo, a doctor would have to tell a person with diabetes that their injuries are possibly vaccine-induced. Hugo says this would be difficult to prove, ³as there is no credible science yet that would make that a likely diagnosis.² Frank Destefano of the CDC says, based on scientific evidence, any person with type 1 seeking monetary damages for vaccine-related injuries would have a very weak case. ³The weight of the scientific evidence does not support a causal association between any vaccine and type 1 diabetes,² says Destefano. Hugo says Classenıs published literature is a foundation, however, he adds, ³By todayıs standards, one would be hard pressed to get a court to adopt those as positive proof.² If people with diabetes want to receive compensation from the U.S. Government, Hugo says they need to file a petition in the VICP and ³keep their fingers crossed that their lawyer can prove the link to vaccines as a cause of the diabetes.² Diabetes Not a Table Injuryı In order to go about proving the vaccine is the underlying cause of their developing type 1 diabetes, Hugo says a person would need competent medical testimony, as they will have to actually prove cause. ³[Proving this] can be rather expensive and a difficult burden,² says Hugo. Hugo adds that diabetes is not a ³table injury² within the table of covered injuries in the VICP, thus making a type 1ıs case more difficult. Shoemaker feels the VICPıs table of injuries is controversial. ³DHHS wants to limit the things contained in the table, probably because they donıt want people to think vaccines cause a lot of problems,² says Shoemaker, adding the Institute of Medicine Report divides injuries into categories such as: 1) those where there is no evidence one way or the other of a causal relationship; 2) those where the evidence favors a causal relationship but there is no good epidemiological evidence to confirm the extent of the risk; and 3) those where a causal relationship has been proven. ³DHHS wants to only include [category three] cases on the table, whereas we argue [category two] cases should also be included,² says Shoemaker, who is taking a different approach by urging a lower burden of proof instead of reliance on the table. Shoemaker says if an injury is not listed under the table of injuries, it can still be proved to be related. ³Under the program that now exists, that requires proving a causal relationship by a preponderance of evidence, much like what is required in civil suits,² he says. Shoemaker agrees that Classenıs published literature might be the only evidence proving that vaccines are the underlying cause of a person developing type 1. ³Which I am sure will be attacked with vengeance,² says Shoemaker. Vinicor says that since there is no evidence supporting Classenıs hypothesis, ³the CDC should get on to the business of the nationıs health and not continually be distracted by a theory without substance.² Classen understands this position in the matter since he says the CDC would be a ³defendant in any vaccine-injury cases.² He adds, ³If CDC admits its data is similar to mine, it runs the risk of having diabetes placed within the table of injuries.² Shoemaker says he has not researched making the CDC a defendant in any cases because ³it would be difficult.² He does feel that diabetes will not be listed under the table of injuries any time soon and that the CDC will fight Classenıs data with all its might. ³The government fought their own data about swine flu vaccine causing GBS and after manipulating the data in totally improper ways they couldnıt make the association go away.² For a complete description of statutes under the VICP, log onto http://bhpr.hrsa.gov/vicp/table.htm. NIH Chief Refutes Classenıs Claims Ethan M. Shevach, MD, chief of cellular immunology at the laboratory of immunology at the National Institutes of Health in Bethesda, Maryland, says Classen was a postdoctoral fellow in his laboratory for three years in the early 1990s. He claims Classen had very little training in immunology before he arrived and functioned in a satisfactory, but not outstanding way. ³I am familiar with [Classenıs] theories, but have never been impressed with any of the data he has presented in public or in the press,² says Shevach. ³He has had absolutely no formal training in sophisticated epidemiologic techniques or methods, and I am not really certain of the reliability of his data-analysis methods.² Shevach believes Classen has a ³rather naïve² understanding of basic immunologic principles and theories. At a May 1998 meeting, according to Classenıs Web site (www.vaccines.net) Classen alluded to Shevachıs data to support his position that vaccines cause type 1 diabetes. Classen wrote, ³Dr. Ethan Shevach of the NIH presented data that certain DNA vaccines probably cause the release of interleukin 14 (IL-14), which can induce autoimminuty.² Shevach responds by saying this is ³absolute nonsense² and that Classenıs Web site is incorrect. ³I gave a lecture on the potential of interleukin 12 (IL-12), not IL-14, to induce autoimmunity,² Shevach says. ³In fact, IL-14 does not even exist.² I presented a theoretical discussion as to how IL-12 itself, or IL-12 induced by DNA vaccination, might induce the differentiation of auto-reactive T cells.² Shevach explains that his data presented at the May 1998 meeting was a ³hypothetical scenario² based on some experiments performed in his lab. Diabetes Interview informed Classen of Shevachıs correction, and Classen said the literature on his Web site would be corrected. Shevach also received Classenıs press release from several colleagues who were aware that Classen trained with him. Shevach says he is shocked that Classen is publicizing information saying people with diabetes can seek legal compensation for their vaccine-induced injuries. ³At this point, I see no hard scientific data to support any of his claims,² says Shevach. ³I think he is doing a disservice to the scientific community and to the families of patients with children with type 1 diabetes.² Shevach also mentions another comment he made at the May 1998 meeting, which was that almost all children who enter day care as infants have numerous natural infectious insults. ³To me it would seem that such natural stimuli of the immune response would be much more potent inducers of potential [autoimmunity] than injection of a recombinant purified protein as a vaccine,² says Shevach. Classen counters that 80 percent of type 1 cases occurring before age 10 are caused by multiple vaccines started after two months of life. ³This guy simply does not know what he is talking about,² says Shevach. A Conflict of Interest? Adding fuel to the controversy, Shevach charges that Classen has obtained patents on alternative schedules for delivery of vaccines to children and that he has a ³vested financial interest in the use of his protocols.² ³I would question whether he has a conflict of interest,² says Shevach Classen says he would never deny that he has patents as well as a conflict of interest. ³The point that Diabetes Interview readers should realize is that patents are worthless unless there is some truth to it,² says Classen. ³You can patent anything but nobody is going to use it unless there is some truth to it. The fact that I have patents does not really explain why I have spent nine years losing money fighting this battle unless I thought it was the truth. I think itıs the truth.² Classen says he has been working in poverty for nine years because, in the end, he feels he will be compensated. ³Thatıs the only reason I am funding my research,² he says. ³I would be insane if I didnıt think I would get something out of it in the end. The world doesnıt work that way.² Classen says people who run ³scams² do not run ³non-profitable scams² for nine or ten years. ³Scams last two or three months,² he says. ³If a scam artist does not make money off his scams, they go on to something else. I have put everything I have into this, and in the end I will profit from it. I will make the vaccine safer and I will profit from it.² Can David Beat Goliath? Attorney Michael Hugo says Classenıs studies ³may very well be right.² If so, he thinks Classenıs findings will be ³devastating to the pharmaceutical industry.² Classen, however, says he is not out to destroy the pharmaceutical industry. ³I donıt get up every morning and say I am going to destroy CDC, although there are some people who get up every morning and want to destroy me,² says Classen. ³In the end it is about making things safer.² Hugo says for Classenıs theories to make an impact, it will take many studies, done by the best doctors money can buy. ³Not too long ago, there was a theory that AIDS was caused by the polio vaccine, since it is made from Simian strains of virus from Green Rhesus Monkeys,² says Hugo. ³This idea has gone nowhere, although it is as plausible a theory as any other.² In Classenıs ³David vs. Goliath² battle, Hugo feels Classenıs theories will probably get discounted by science the same way the AIDS/polio vaccine theory was. Classen says he is 100-percent confident his science will win out in the end. ³You can look at Charles Darwin when he proposed evolution and how the church and everyone else was against him,² says Classen. ³Or when Aristotle said the earth rotates around the sun instead vice versa. Science was on their sides. In the end, science wins out, and that is why I continue. That is why I take on the biggest people, because I know the science will win in the end.²