I was having a very quick read through -
UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE MEETING
May 26, 1998
(development of a candidate vaccine for the prevention of Lyme disease.)
It didn't take long to realise that chronic difficult to treat Lyme Disease and problems with testing were all acknowledged many years ago, just not talked about in guidelines used for treating patients in the field.
Are we the sacrificial lambs in this race for a vaccine? Are the thousands of wasted lives so unimportant to our Health Departments?
These are just a few comments extracted from this report:-
'I think that it is helpful to think about early and late disease. And clearly something happens between early disease, which is easy to treat, and as Dr. Luft points out, if we didn't ever miss it, we wouldn't need a vaccine. But we do miss it. And late disease, where presumably some other pathogenesis is at work because it is hard to treat. But I would think of these as useful rules of thumb. And I don't think that the statistical information is invalidated. I think if we have eradicated the disease early, it doesn't have a chance to occur late and demonstrate a statistical difference.'
DR LUFT: "The point that I wanted to make in regard to the study is that there is very heavy dependence on serologic confirmation. ***And when we start thinking about the adverse events, it was stated originally when we got the overview of the disease that the disease is really quite protean. And actually the adverse events are very similar to what the disease manifestations are. And if you start to, as I think Dr. Hall was eluding to -- if you start to kind of say well how often do you actually become sero positive, you can start to have a different take on when someone has an adverse event of whether it is disease specific or infection specific versus vaccine specific. And I think that that is an important issue that we have to deal with.***
DR. LUFT: 'Well one I think very large issue, and I am not sure it is within the purview of this group, is that the sero diagnosis for Lyme disease in the vaccinated patient population has become extremely difficult and very expensive as a result of this vaccine. What is happening is that all current ELISA's will no longer be useful and that we will have to use Western blot, which is a very costly diagnostic test for the primary diagnosis of patients. And I think that there has to be some work done for the development of new diagnostic testing as well as new diagnostic criteria for this particular patient population. It is going to become a very cumbersome and expensive venture.'
DR. LUFT: 'I think it is important to realize that this vaccine has a built in adjuvant in it. I mean, it is a lipoprotein and I am not sure how many vaccines are out there that are lipoprotein that has a variety of immunogenic activity in itself and how that might affect either the fetus or the reproductive status of the individual is really unknown. So I would be very -- I would approach that whole issue as to vaccinating someone with a lipoprotein with real caution. Just because we don't have any data in that regard.'
Our doctors have been well and truly duped by those who have disseminated false information and colluded to distort the science in the interests of what? Money, vested interests, vaccines reputation?
Thanks to Tick Talk Ireland for this excellent information here