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                  <text>I1
mm.--.-..m-w1

March 9, 1985
Mr. Peter Irwin
Medical Research Department
Sandoz Inc.
Hanover, New Jersey
Dear Peter,
I read the article by Glassman
st 31. and react much as you did. There is
as much evidence that drowsiness was the active component in the effects on
craving as that a specific biochemical process was responsible. But it seems
difficult to attack the conclusions based on these data alone. I seem to recall that
our subjects, given clonidine, also had a significant degree of drowsiness, as did our
subjects when given higher doses of diazepam and bromazepam. Also, the time
course of our experience would be applicable.

In order to do justice to a critique of this report, I think we would have to

extract some of our own data, see if they are relevant, and make a more

compelling case than your argument. The dependence on the PDR does not have
much cachet; indeed, it is not considered a relable source of scientific information,
being seen as a negotiated average of sentiments between legal partisans from
industry and less-than-competent administrative bureaucrats. Such an argument
may have place in the board-rooms of industry or the law courts, but hardly in
SCIENCE.
am so busy with convulsive therapy, that Glassman's peccadillos and the
pseudo-science of SCIENCE influence me little.
I

The historical paper which I wrote for IPEG in memory of Bente has been
published. I enclose a copy for your bulletin-board.
The IBM 1800 is acting up again, and i am getting desparate to end it all,
either by decapitating the machine and chucking all the work, or by replacing it
with the H21 IBM-AT based system. I am visiting HZI next week to see if there is
some fire where there has been nil-smoke for so long.
Meanwhile, Itil has convinced Hoffmann-La Roche that he can distinguish
three
formulations of Valium; they have petitioned the FDA to change the
among

rules on generics and look-alikes by requiring pharmacodynamic equivalence as well
as pharmacokinetic and chemical dissolution equivalence. The petition went in two
weeks ago; you can read all about it in the pink sheets. if the FDA is convinced and
changes the regulations, industry will need our pharmaco-EEG studies as much as
they needed the sleep-EEG studies when the FDA accepted such studies as
evidence of soporific activity. If the FDA acts favorably, I will get my new AT
system; and you could go into business for yourself with little investment.
Keep the faith. My best regards.
Sincerely yours,
“it

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