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  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
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  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
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  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.
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  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.)