Posted by Ellen on October 30, 1999 at 11:21:56:
In Reply to: Re: Assoc. between type 1 and Hib vaccine posted by Ellen on October 30, 1999 at 11:04:40:
MAR, this letter has some info about HepB from Classen's point of view. I suggest for people interested in the journal discussions between researchers on this controversial topic, go to http://www.bmj.com and search under authors for Classen. You'll be able to click on the various letters and the responses. I've only provided Classen's viewpoint here at TIF.
Authors' reply
EDITORJefferson et al confuse readers about our research. Haemophilus
influenzae type b immunisation was initiated in Finland to prevent
7 deaths and 7-26 cases of severe disability (mean benefit
23.5 children) per 100 000 immunised.1 Our analysis on a collaboration
monitoring Finnish data found that children receiving 4 doses of the
vaccine had a higher rate of type 1 diabetes than did unimmunised
children by more than twice the mean number of children expected to
benefit from immunisation. Jefferson et al attempt to downplay this,
stating that type 1 diabetes is rising in Finland. In fact, the
incidence of type 1 diabetes in ages 5-9 was stable from 1983 to
1992 until the children vaccinated with H influenzae type b reached this
age and type 1 diabetes rose by a rate exceeding the mean benefit of the
vaccine. We conclude that the potential risk exceeds the potential
benefit, showing the need for safer immunisation technology.
The Cochrane review that Jefferson et al mention omits important
references, including a preliminary study by the Centers for Disease
Control and Prevention. This study supports our data that hepatitis B
immunisation starting after 2 months is associated with a more than 60%
rise in type 1 diabetes. The authors criticise us for not having our
analysis peer reviewed, but our collaborators asked us not to publish
the data to allow all researchers to review them. Several trials of the
vaccine were performed in Finland, and we are completing the analysis of
these.
Jefferson et al misrepresent us by citing patents drafted by lawyers. We
believe that starting immunisation in the first month will optimise the
trade off between preventing infection and inducing autoimmunity.2
Studies are feasible to show that immunisation starting at 4 weeks
compared with immunisation starting after 8 weeks will decrease the risk
of type 1 diabetes.3 Killed vaccines are routinely given in the United
States as early as 6 weeks, and starting at 4 weeks is acceptable to
many. Finnish researchers indicate that H influenzae type b immunisation
may begin at 4 weeks,4 which may decrease the risk of type 1 diabetes.
It is feasible to compare the effect of hepatitis B and BCG vaccines on
type 1 diabetes when given starting at birth and starting after 8 weeks
since these are routinely given then.
French officials stopped hepatitis B immunisation of schoolchildren
while continuing neonatal immunisation, reportedly because of the
increased risk of autoimmune neurological diseases after immunisation of
schoolchildren. French courts have demanded that health officials make
safety a priority. Will Jefferson et al remain opposed to our research
when the United Kingdom adopts this policy?
In answer to Elliman's letter, we will comment on the meeting in
Baltimore when we see a published report from it. To our knowledge no
consensus was ever reached. There are clearly differences of opinion
regarding safety of vaccines. American law prohibits the marketing of
pharmaceutical products if safety has not been demonstrated. Our
research has shown that this criterion has not been met with the H
influenzae vaccine, so changes are clearly necessary. Some public health
officials believe in promoting the vaccine until they are convinced that
it is causing harm, but this is not consistent with American law.
American laws may not be accepted in many countries, and the
risk-benefit of immunisation will be different in developing countries.
We believe that our analysis of the data is consistent with American law
though understand that many may oppose this standard. A complete list of
references and a longer reply is at http://vaccines.net.
John Barthelow Classen, President.
Classen Immunotherapies, 6517 Montrose Avenue, Baltimore, MD 21212, USA
classen@worldnet.att.net
David C Classen, Infectious diseases physician.
Division of Infectious Diseases, LDS Hospital, Salt Lake City, UT, USA