To the LAG membership:

It has been quite some time since the coordinators
have offically updated the group on the current status
of Lotronex.  I would like to take this opportunity to
relay to you what I can about what is going on.

I have recently spoken with a GSK representative and
an FDA representative.  As you already have heard
numerous times, both parties positions for the record
are that they are continuing to work with each other
to bring a resolution to this issue.  

While this is very true, and the issue is not dead, I
can tell you that neither party is moving with any
kind of diligence or speed to resolve the issue.  It
appears the needs of the patient community is on the
back burner due to issues of money and politics.

As many of you already know, there are researchers and
doctors in the OPDRA (Office of Post Drug Risk
Assessment) department of CDER (Center for Drug
Evaluation & Research) of the FDA that do not feel
lotronex is either safe or that it works or both.  The
LAG has reached senior officials in CDER and, in my
opinion, has convinced them that IBS can be
debilitating.  They have stated to us many times,
including the Director, Dr. Woodcock, that they
understand the urgency and need of the patient
community and are doing everything possible to help
us. THIS IS SIMPLY NOT THE TRUTH!  The senior
officials in CDER that have the authority to move
things along, have caved to the those in OPDRA that
have leaked and distorted information to the media in
the past.  The bad press the FDA received in the
Lancet article and the LA Times has scared the senior
officals away from taking action due to their fear of
losing their jobs.  Therefore, it is my opinion that
the actions of the FDA are dictated by politics and
the press and not what is in the best interest of the
patients.

On the other side of the table, GSK is more than
UNWILLING to provide Lotronex under and IND
(Investigative New Drug -- term form Compassionate
Use). The FDA has stated in the past they they will
allow GSK to provide Lotronex under an IND
classification.  GSK simply will not.  Speculation of
the reason for this is that by providing the medicine
under an IND, GSK would be admitting that the medicine
is not safe and needs to be experimental. 
Undoubtably, this would strongly hurt their chances of
beating the many lawsuits ongoing from those that have
claimed to have suffered from using Lotronex.  The end
result comes down to one simple thing -- MONEY!  GSK
can provide us the medicine, but they will not due to
money.  They could also provide the medicine in
Mexico, where it was approved to be sold before the
FDA told them to stop selling it.  GSK's actions
indicate a company more interested in money than in
the needs of patients with a debilitating illness.

So, it appears we are caught in the middle of this
game of politics and money.  In my opinion, the longer
this goes on unresolved, the less chance we have of
regaining access to the medicine that is so critical
to all our lives.

At this point, I would once again ask of you all to
keep writing and calling (everyday if necessary). 
DEMAND access to the medicine.  Both parties need to
know that we are not going away.  They are treating us
as if we are irrelevant.

One last word, I would strongly encourage anyone that
is experiencing or experiences complications in the
future due to resorting to other medicines not
designed to treat IBS, to seek legal action against
the FDA.  The FDA fails to realize that it is more
dangerous for us to resort to all of these other crazy
medicines and constant use of over-the-counter
medicines (ie.. immodium, pepto etc..) that are not
meant to be taken for long periods of time, in order
to seek some relief from our illness.

Sinerely,

Corey Miller, Coordinator
Lotronex Action Group