Provided courtesy of Diabetes Health Magazine

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

             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

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

            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

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 ( 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

            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

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

            ³This guy simply does not know what he is talking about,² says

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

            ³I would question whether he has a conflict of interest,² says

            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