Dear Taylor,

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

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

Sam

Taylor wrote:

Sac> Hi Alex, about your theory of cows as antibody factories and the Impro
Sac> story...

Sac> Ok, let's see....

Sac> In about 1980 I worked in a friend of mine's law firm.  There was a client,
Sac> Impro, a company formed and run by a family by the name of Collins.  Mary
Sac> Collins was the President of Impro at that time.  I worked with her brother
Sac> Jim the most.  At that time he was in his 70's.

Sac> The issue I worked on was the testing of Impro by the FDA, which had been
Sac> performed some years before.  I believe that it may have been 10 or l5 
years
Sac> before.  The testing seemed to show that Impro was not effective in
Sac> increasing milk production in cows (increased milk production was one of 
many
Sac> claims on behalf of the product...I'll get the the medical ones later) a
Sac> finding which was completely inconsistent with the family's work with their
Sac> cows for 20 plus years.  The family was stunned, but found themselves
Sac> stonewalled by FDA.   They hired a lawyer, the founder of the firm I worked
Sac> for.  Unfortunately, the founder of the firm, who worked at the 
headquarters
Sac> in Iowa, was nearly certifiably insane.  Although he of course treated the
Sac> Collins like family, and for years they thought he walked on water,  his
Sac> manner with everyone else was atrocious.  He was an intimidator of the 
worst
Sac> sort. I have plenty other things to say about him, like he skimmed the 
till,
Sac> but this is the relevant quality he brought to bear in this case. He
Sac> attempted to proceed to convince the FDA by intimidation to repeat the 
test.
Sac> The FDA dug their trenches even deeper.

Sac> The whole family smelled a rat of some type.  My memory of what they did
Sac> before I met them is sketchy, but it is my understanding that they
Sac> interviewed some of the farmers about the tests personally, and found
Sac> terrible deviations from the experimental protocol.  However during these
Sac> interviews their upset about what they were hearing, and their lawyer's
Sac> atrocious manner, got the farmers in an uproar, and communications 
completely
Sac> broke down. Investigation into what happened was discontinued.

Sac> Now, my contact, Jim, was rather unusual.  The rest of the family didn't 
take
Sac> him quite seriously.  He was thought of as the odd duck.  His form of
Sac> communication was unique...I don't know how to describe it to you, really,
Sac> except that rambling might hint at it.  And although he was in his 70's, he
Sac> was quite innocent, and almost like a child.  He was very dear.  I just
Sac> seemed to know how to hear him.

Sac> Over the years Jim had continued relentlessly in his statistical evaluation
Sac> of the data they had managed to get from the first few farmers they
Sac> interviewed.  Jim's statistics finally convinced the family to let him go 
to
Sac> the individual farms involved in the test and interview some of the other
Sac> farmers to see how they had performed their tests.

Sac> Because I paid attention to his statistics and could see his logic, and my
Sac> understanding somehow helped convince his family that he was onto something
Sac> worthy of the money it would cost to investigate, and because he felt I 
would
Sac> be a good diplomat with the farmers, everyone agreed he should take me 
along
Sac> to help out.  We traveled around for about three months.

Sac> What we found out was that the FDA didn't bother to communicate to the
Sac> farmers what the experimental protocol was supposed to be.  Each farmer
Sac> performed the "experiment" in a different manner from the other.  None but 
a
Sac> very few were told the entire protocol.  I remember that among other things
Sac> there were issues to do with  timing which were critical, and timing issues
Sac> were wholeheartedly ignored by the FDA in all but one or two cases.

Sac> Note:  because this test involved cows, and because the FDA did not keep
Sac> cows, the FDA contracted with individual dairy farmers for the experiment.
Sac> For some reason, Impro was not involved in the process of communicating the
Sac> experimental protocols to the farmers.  Whether it was because the FDA
Sac> insisted on keeping the reins, or whether Impro just trusted the FDA to do
Sac> right, I don't remember.

Sac> So the results were all over the place.  But the few farmers who did 
receive
Sac> the entire protocol, or a nearly complete protocol, had great results.
Sac> However, the FDA would not acknowledge the disaster surrounding its
Sac> communication of the protocol, would not agree to a retest, and at the 
time I
Sac> left the firm were still shutting the Collins family, and its nutty lawyer,
Sac> out.  I don't know what became of it all.

Sac> Now Impro was made by ...let's see if I remember this correctly... a 
process
Sac> whereby an antigen substance ...a bacteria in a form something akin to a
Sac> vaccine... was given to the cow in her udder.  I believe I'm remembering 
this
Sac> correctly.  When the cow calved, the milk would contain antibodies specific
Sac> to the bacteria with which she was innoculated.  The whey would then be 
taken
Sac> from the milk, and it was that product which would then be bottled and 
given
Sac> to people sick with the bacteria, and it would cure them.  There was some
Sac> information about the colostrum from those cows, but that information 
hasn't
Sac> surfaced yet from stirring my mind on these long ago events.

Sac> Impro had incredible potential.  They had used it with fantastic results on
Sac> many, many sick people who were at the end of the medical factory's ropes.
Sac> People who had been left to die by their doctors experienced a return to
Sac> health after taking Impro.  The whole reason it failed to become known had 
to
Sac> do with the FDA's test.

Sac> Almost unbelievably, the failure of the test could be raced back to an old
Sac> rivalry between the then-head of the FDA and the inventor of Impro.  (The
Sac> inventor was not in the Collins family, but the Collins family took it on 
for
Sac> the inventor, and refined the idea over many years.)  The Collins believed
Sac> that the reason the communication of the test protocol was performed in a
Sac> slip shod manner was because of shear spite.  The rivalry had been terribly
Sac> bitter and intense..I can't remember the details now.   I have flotsum of
Sac> details floating about in my brain...something about the inventor beating 
the
Sac> FDA head to the punch in inventing Impro... they had both been in some
Sac> professor's class together in college, gotten similar ideas because of this
Sac> class, but one the inventor came up with a workable solution before the
Sac> other...

Sac> So, there...that's the story.  Sometimes it makes you feel like we need to
Sac> start the world from scratch again, doesn't it?  Entanglements inside of
Sac> entanglements... what a mess we are in.  It reminds me of the FDA going 
after
Sac> CS.  Who can know what motivates such things?

Sac> Best wishes,
Sac> Taylor



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