From: EXECSEC
Sent: Monday, December 11, 2000 7:52 AM
To: Dockets, FDA
Subject: FW: LOTRONEX

-----Original Message-----
From: Henney, Jane 
Sent: Friday, December 08, 2000 6:19 PM
To: EXECSEC
Subject: FW: LOTRONEX

> ----------
> From: 	
> Sent: 	Friday, December 08, 2000 6:19:21 PM
> To: 	JHENNEY@OC.FDA.GOV
> Subject: 	LOTRONEX
> Auto forwarded by a Rule
> 
I would like to address the recent decision by the FDA to remove Lotronex
from the market.   I have been an IBS sufferer for most of my life.  When I
was younger,  I was hospitalized twice for dehydration from diarrhea.  I
have found that as I age, I am now 57, the IBS is increasing in frequency
and severity.  It  is not unusual for me to have two to three bouts of
diarrhea a week.  The most common trigger for my episodes are foods and
travel.

Let's discuss food.  I can't eat any dairy, caffeine, chocolate, fruit
juices, any fatty or fried foods, and some vegetables.  Granted many of
these items aren't good for you, but because of my total intolerance to any
dairy foods I have beginning osteoporosis.  Because I have an extremely
sensitive stomach I can't tolerate calcium pills, they nauseate me.
Therefore, when I began using Lotronex last July, I was delighted to find I
could tolerate dairy products.  Lotronex  changed my life and allowed me to
eat a more balanced diet.  I can now go to lunch with my friends and not
worry if I accidentally get a touch of dairy food in my meal and have to
spend the next several hours in the bathroom.  I not only get severe
diarrhea that lasts for several hours, I get cramps so severe, the pain
causes me to vomit.  I also can't go to many restaurants because there's
nothing on the menu I can have.

Now let's talk about travel.  As a part of my job as Corporate
Administrative Services Manager of a Fortune 500 company, I have to travel
monthly from ------------.  Because of your position, I am sure you
are a frequent traveler and know how bad airline food is.  There is seldom
a time when the meal does not include a dairy product, even if its a
sandwich.  The alternate meal is usually fatty.  I have tried having the
special meals but there has not been one offered that addresses this
condition.  I can take something on the plane with me when I leave from
home, but there's not much I can do for the return trip.  Airport food is
not conducive to an IBS diet.  I also am required to attend many business
lunches, dinners, and conferences.  Invariably,  much of the meal is a
problem for me.  Also, traveling is hard on the body and even if I eat very
carefully, the time changes and exhaustion that accompany traveling often
bring on a bout of diarrhea.

I felt like a new person when I began taking Lotronex.  My doctor did not
start me out on two pills, he suggested one, which I did well on.  Then he
told me he had some patients that only needed half a pill.  I then tried
that and found it worked well 90% of the time.  I take as little medication
as possible as most of it doesn't agree with me.  I understand your
concerns about the drug.  But I strongly feel the 500,000 people that have
prescriptions have a right to this medication.  I think with proper
training of the doctors and patients, the few incidents of concern could be
eliminated.   I don't think everyone who takes it should be punished by a
few isolated cases that, with proper monitoring, probably wouldn't have
happened.

I don't agree with the FDA that because this "condition" isn't life
threatening,  the drug is not needed.  I have episodes severe enough  that
my colon gets so inflamed I pass blood clots.  I would like anyone at the
FDA who feels this isn't a significant condition  to walk in my shoes for a
few months and go through what I do.  I can't go anywhere unless I know
where the closest rest room is.  I have to get up and excuse myself from
business meetings and often can't continue with the meetings.  I always
worry on the airplanes that I will have an episode and not be able to get
to the rest room in time.

I also wonder if this medication worked on men and not just women if the
decision would have been different.  Women have been on the short end of
the stick in the health care system for years.  Women weren't even included
in most of the trials for new drugs.   I also find it very interesting that
Accutane can be on the market although it is showing a strong possibility
of causing suicide in its young users.  It's OK to let teenagers take a
dangerous pill that causes depression deep enough to cause them to commit
suicide just so they can have clear skin, but I can't take a pill that lets
me live my life outside of a bathroom.   And I do not agree with the
thought that IBS is a symptom of stress.  It that were so why is my problem
better on one-half of a pill than on no pill when my stress level is the
same.  My triggers are fatigue and foods which I don't always have control
over, although I do my best because it's no fun living my life on a toilet.

Please reconsider your decision on this product and give me back a normal
life.  If you would like further information, I have included my home
address and phone number below or you can reach me by my company e-mail:
pahout@beckman.com.

Thank you for the time you spent reading this message.