🚀 go-pugleaf

In article <NEWTNews.4369.793953004.craiga@craiga.rmii.com> craiga@craiga.rmii.com writes:
>
>In article <01HNIE0TB0JE8ZFDCT@vaxc.hofstra.edu>, 
><mic2mcb@leeds.ac.uk> writes:

>> I  am a final year student of microbiology at the University 
>of Leeds and i am
>
>Actually, there is a company working on a vaccine, headed by 
>Jonas Salk.  There preliminary work has shown promise, however 
>they are fighting with the FDA regarding the third clinical 
>trial.  The company is named Immune Response.  The second 
>clinical trial were criticized by the FDA, as the company did 
>not do them as the FDA, wanted them done.  Sounded like 
>stonewalling to me.  They are way ahead of anyone regarding 
>this issue.  Food for thought.
>

While it is fashionable to bash FDA, this is a way overly paranoid
interpretation. Very pressing and relevant questions about potentially
deceptive trials methodology were raised, not by FDA, but by a joint
meeting of the antivirals and biologics advisory board-- an independent
group of consultants that includes community clinicians, diverse
researchers, bioethicists, PWAs, etc.

I haven't gotten the full transcript of that meeting from the FDA
Freedom-of-information-act office, but I am aware of some of the
panel's criticisms-- among them the misrepresentation of
non-statistically significant trends as findings, and the use
of post-hoc analyses. If the vaccine is truly good, it should
stand up to the same critical inquiry as is expected for all
treatments. This bending of the rules makes one wonder how much
confidence Immune Response has in their own product...

It's also interesting that what they did was not incredibly
different from what Robert Redfield did with the Army's gp160
trials, yet the community reponse was very different. Could it be
perhaps, that  this is so because one was the US army, and the other
a very sophisticated and slick biotech companty that has gone out
of it's way to court the affections of the activist community?

Finally, I think all of this is tangential to the original post:
I believe that the poster was discussing preventative vaccines,
not therapeutic vaccines (which is what the Salk Immunogen
purports to be)

Carlton

 _______________________________________________________________________
 |                                                                     |
 | Carlton Hogan  (carlton@gopher.ccbr.umn.edu)                        |
 | Community Programs for Clinical Research on AIDS Statistical Center |
 | Coordinating Center for Biometric Research                          |
 | Division of Biostatistics, School of Public Health                  |
 | University of Minnesota                                             |
 | 2221 University Ave SE, Suite 200         Voice: (612) 626 8899     |
 | Minneapolis  MN 55414                     FAX: (612) 626 8892       |
 |_____________________________________________________________________|
   Affiliation Provided for Sake of Identification, not Representation