Hi All,

Sam and I have been having a little discussion I thought it would be well to 
share, because it clears up a few things in the cow antibody story.  He has 
given his permission for me to share these private emails.  

Here goes:

Dear Taylor,

Sac>   A fascinating and disturbing story indeed. One thing puzzles me
Sac>   though. I happen to edit health industry news including FDA
Sac>   approvals, trials, etc., and it's been my understanding that the
Sac>   FDA doesn't test anything -- it's up to the applicant to
Sac>   organize, operate and pay for all studies and clinical trials.
Sac>   The results are then presented, sometimes to an FDA expert panel,
Sac>   or directly to the FDA commission if they're feeling especially
Sac>   favorable (for whatever reason). The expert panel recommends and
Sac>   the commission usually, but not always, takes its recommendation.
Sac>   But no one at the FDA does anything but review the results of the
Sac>   research the applicant has done.

Sac>   Can you tell me why the Impro investigation was done differently?

Sac>   Sam

Sac> << Hi Sam,

Sac>  I was messing with my fish tank last night, stirring the bottom up 
getting
Sac> plants out, and as I watched the mulm (gunk) swirl up and float around, I
Sac> pondered Alex's request for more information about Impro.  It seemed to 
me
Sac> that I'd have to stir the bottom of my mind tank, and probably some stuff
Sac> would swirl up and around, just like in that fish tank, and some stuff 
would
Sac> stay sunk between the rocks.  So as I went to bed that night, pieces of
Sac> information swirled in my brain.  Even after sending the story to the 
list, I
Sac> thought of how I should correct or expand on this and that.

Sac>  Let me see if I can clarify the facts of which I am certain, and those 
not.

Sac>  First, before I get to the trials, let me correct this: it wasn't the 
head
Sac> of the FDA who went to the same class as the inventor, I believe it was 
the
Sac> head of whatever department was connected with the trials.  I'm sorry I 
can't
Sac> be clearer than that.

Sac>  I believe Impro did have to pay for the trials.   I am clear that Impro 
did
Sac> not, and perhaps was not allowed to, instruct the farmers on the 
experiment's
Sac> protocol.  That was handled by the FDA.  The farmers themselves told me 
about
Sac> this.  It may be that trials of 30 - 35 years ago were handled 
differently.
Sac> It may even be that they are handled differently because of this case.

Sac>  By the way, other thoughts I'd like to add to the story were these:

Sac>  The reason they decided to test milk production at the first trial, was 
that
Sac> they thought it was the path of least resistance.  They had had 
consistently
Sac> excellent results with milk production.  They thought if they could pass 
that
Sac> FDA hurdle, they could then get into the much more political arena of 
medical
Sac> uses for Impro.  They didn't want to take on the pharmaecological 
industry
Sac> until they had something else going for them.  What happened is very sad 
for
Sac> us all.

Sac>  The trials were well before I came on the scene.  I do not know how the 
data
Sac> got to the FDA.  I don't think the Collins dealt with the farmers in any
Sac> capacity until investigating the results, but of that I am not absolutely
Sac> certain.

Sac>  Best wishes,
Sac>  Taylor

Lastly, this is part of another email:

[from Sam]

<<It also occurred to
<<me that it might not have been the FDA at all, but the USDA, as
<<the FDA may not get involved in animal care and milk production
<<issues, especially several decades ago.  I know the USDA and many
<<state agriculture agencies get involved in research projects with
<<farmers and manufacturer/researchers. Is this possible, given
<<your admittedly murky memory?

<<In any case, post anything you like of what I wrote, and thanks
f<<or your response.

<<Sam

<<Ok, Sam, thanks.

<<You might be right about the USDA.  It makes more sense.  I think the plan 
was for Impro to get the veterinary ok, then proceed to FDA for the medical 
ok.  

<<Best wishes,
<<Taylor

Sorry, everyone, about being so hazy.  I haven't even given this matter a 
single thought in at least 15 years.  It's been 19 years since I worked on it.

Best wishes,
Taylor




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