Ive just read documentation that lists BCG as the cause of
Autoimmunity, Hepatitis
several cases in fact, they include Lupus, Reiters

Reiters
http://linkinghub. elsevier. com/retrieve/ pii/S08968411009 04943

Reports on  1 case of Reiters after BCG treatment.  No data at all suggests that Reiters is more common after BCG treatment that without BCG treatment.  For a drug like BCG, which has been given to 100s of millions of people, you would expect some people to get Reiters after it, just because you are giving it to so many people.

Lupus
http://www.annals. edu.sg/pdfSep02/ TanHH.pdf

Reports on between 1 and 4 cases of Lupus after BCG treatment.  No data at all suggests that Lupus is more common after BCG treatment that without BCG treatment.  For a drug like BCG, which has been given to 100s of millions of people, you would expect some people to get Lupus after it, just because you are giving it to so many people.

Hepatitis
http://www3. interscience. wiley.com/ journal/11267939 5/abstract?
CRETRY=1&SRETRY= 0

Reports on  a single hepatitis case  which occured 1 1/2 years after BCG treatment, in someone who already had bladder cancer.  No data at all suggests that hepatitis is more common after BCG treatment that without BCG treatment.  For a drug like BCG, which has been given to 100s of millions of people, you would expect some people to get hepatitis after it, just because you are giving it to so many people.

And this link shows a whole heap of adverse reactions
http://www.whale. to/vaccines/ bcg.html

This is a site full of quack vaccine-hater stuff.    If you see any specific study there you want comments on, give me a more specific link.  In the past when I have looked at this site, it has been a mix pseudo-scientific crap, made up data,  fearmongering, and bad statistics.

Also read that NOD mice given BCG prevented diabetes but end up with SLE
http://www.pubmedce ntral.nih. gov/articlerende r.fcgi?artid= 1414944

This is an  interesting study.  However, I think it is a mistake to think that the BCG cause the SLE in these cases.  These were NOD mice, which are genetically bred to have immunology problems!  It may just be that the BCG kept them healthy long enough to get SLE, when not giving the BCG caused them to die of type-1 diabetes before they could get SLE.  If I have time, I'll read this study and give a more complete answer.

More
http://www.jcu. edu.au/cgc/ AutoimmunityResR ep.html

I don't see that this web page has anything to do with BCG causing diseases.  It is all about genetic markers.

I guess my point is..is BCG really safe?...I guess thats why there IS a
Phase 1 afterall.

BCG is safe when used as a vaccine, and we know this because people have done large scale studies that compared vaccinated to unvaccinated people, to see relative health problems, and found the BCG vaccinated people had no extra problems (and less TB).  This sort of comparison study is how safety is measured, and none  of the studies you listed above is this kind of comparison.

Let me ask you a counter-question: is driving a car "really safe"?  Far more poeple die while driving than die from a BCG vaccination.  The difference is 100,000 to 1 or more (maybe even 10 million to 1).  Do you drive?

In terms of safety testing, remember that Faustman's trial only follows the patients for a year or two (someone can fill in the details).  So it will catch bad side effects that happen quickly (especially at the time of dosing), but not those that take years to show up (if there are any). 

Joshua Levy