Page
501
1 able to have
adequate frequency of donation in
2 a manner that
doesn't adversely impact their
3 symptoms.
4 It doesn't
create a high risk of
5 the types of
symptoms that we said could be
6 related to
iron deficiency. It would be, in
7 essence,
comparing strategies to determine
8 whether or
not the benefit, which is a
9 combination
of a regular donation cycle and an
10 absence of adverse
symptoms can be achieved,
11 and that there
aren't unintended negative
12 effects.
13 That is
ultimately what we are
14 trying to do. We
are trying to think -- I
15 mean, (c) has the
appeal that if you lengthen
16 this interval we
are not having to intervene
17 with iron
supplementation, dietary, etc. It
18 might be the right
answer.
19 But the downside
to that is we
20 could be taking
our principle donors and
21 extending
extensively the time period between
22 their donations,
and then we'll have the type
Page 502
1 of discussion
we had this morning which is how
2 do we restore
a diminished or a lessened
3 supply, a
lessened blood supply.
4 It seems the
benefit here is to
5 come up with
a strategy that allows us to
6 allow people
who are interested in regularly
7 donating to
continue to do so in a fairly
8 optimal
manner without creating a risk of
9 enhanced
symptoms that are associated or
10 mediated through
iron deficiency.
11 DR. CRYER: I'm a
little worried
12 about that, in the
sense that the beneficiary
13 of that trial is
our patients and our blood
14 supply and not the
donor. We are putting the
15 donor at risk in
that situation, and we could
16 be accused of just
giving them stuff to try to
17 make them a better
milk cow.
18 DR. FLEMING: The
fact of the
19 matter is we are
already are in a domain here
20 where there is a
great deal of altruism.
21 People are
contributing specifically to
22 benefit society,
and we just want to make sure
Page 503
1 that when
they are doing so we aren't
2 compromising
their own interest. It may be
3 necessary
to-- it may be thought to be
4 necessary--
to intervene to allow them to
5 continue to
maximally contribute. Then you
6 are treating
somebody, and it may be a little
7 similar to
mother/child transmission of HIV
8 where you may
be treating a mother to
9 ultimately
impact her ability to give birth
10 without
transmitting HIV. You are potentially
11 intervening to
enable someone to more
12 effectively carry
out their altruistic intent.
13 DR. SIEGAL: I
think that you are
14 dealing with a
population, at least in the
15 studies that have
been done so far who are
16 demonstratively
marginally iron depleted to
17 begin with, and
the only proposal that would
18 be reasonable, it
seems to me, is to give back
19 what you've taken
in a blood center. So if
20 you are removing
iron from someone, you're
21 creating an
iatrogenic disease in effect, even
22 though you may not
be the providing physician.
Page 504
1 It certainly
seems ethical when you presume
2 the marginal
supply of iron to begin with to
3 replace
what's been removed. I don't think
4 that is going
out on a huge limb, that is to
5 say replacing
donating females, because there
6 is this
altruistic issue that shouldn't be
7 ignored, and
we do need a blood supply.
8 DR. KLEIN: I
would go even a step
9 further to
say that we are already managing
10 donations and
donor safety. We are just doing
11 so with limited
objective information.
12 Perhaps it's about
time that we got some
13 better clinical
endpoints to go along with our
14 laboratory
data.
15 DR. SIEGAL: Is
there any
16 additional
discussion? If not, I proclaim
17 this session
adjourned. See you tomorrow.
18 (Whereupon, at
6:27 p.m. the
19 meeting was
adjourned.)
20
21
22
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