May 21, 2001
To Whom It May
Concern:
The Lotronex Action
Group (LAG), a group of former users of the medicine Lotronex (alosetron
hydrochloride), is deeply concerned about how perceptions of diarrhea
predominant Irritable Bowel Syndrome (IBS-D) may be affecting the Food and Drug
Administration’s consideration of risks and benefits related to use of Lotronex
and/ or other IBS-D treatments.
Although IBS-D is
viewed as a non-fatal disease, its effects are often debilitating. The typical sufferer of IBS-D is a 40-year
old female with primary symptoms including multiple and daily explosive
diarrhea attacks and severe daily abdominal discomfort. The most common secondary side effects
include panic attacks, depression, withdrawal from social and family
activities, severe disruption of daily activities and mal-nutrition.
The typical IBS-D
patient has suffered from the illness since their early teenage years. The adverse impact of IBS-D on patient quality
of life is dramatic, causing the typical sufferer to forgo many aspects of life
that others take for granted. For
example, some of our members have been forced to relinquish their social lives. Others have given up careers, and live as
captives in their own homes. People
fortunate enough to have met an understanding partner and to have children,
often are not able to attend functions with their kids or participate in common
daily activities. In many cases, the
inability to lead a ‘normal’ life causes severe depression and suicidal
thoughts. When IBS-D patients try to
take part in daily activities, they are often subject to panic attacks when
confronted by situations in which a restroom is not nearby, or suffer
embarrassing ‘accidents’ of defecation.
IBS in general has
been estimated to occur in 15-30% of the female population, and this illness is
not uncommon in males. IBS generally
occurs in two types: diarrhea predominant or constipation predominant. It also can occur at a variety of severity
levels ranging from general discomfort to debilitating. The Lotronex Action Group is comprised of
women and men, suffering from the most severe and debilitating symptoms of IBS.
Many of us have found Lotronex to be the only effective treatment for IBS-D,
enabling many patients to assume normal adult lives for the first time.
The widely held view,
from those that do not suffer from the illness, is that it is not life
threatening and is only an inconvenience.
The Lotronex Action Group firmly believes this view is misconceived and
erroneous. The illness is debilitating,
as described above, for a large proportion of sufferers. ‘Zero’ risk tolerance is not an appropriate
regulatory perspective for Lotronex or any other effective treatment for IBS-D.
All medicines have
some level of risk. Current
unavailability of Lotronex leaves many patients with no satisfactory treatment
option. Some turn to other prescription
medicines not suited for the illness, while other abuse over-the-counter
medicines like Pepto-Bismol and Imodium with serious potential adverse
consequences.
The members of the
Lotronex Action Group are prepared to accept risks related to use of Lotronex
and other effective treatments for IBS-D.
We are also prepared to participate in programs to better characterize
risks related to use of Lotronex and other treatments, and to work with the FDA
to reduce those risks to the extent possible.
We request that you re-examine and redefine the severity of IBS-D and
the level of risk that is tolerable for an effective treatment for this
debilitating condition. IBS-D, while
not directly deadly, can be life threatening and causes severe damage to the
quality of the lives of the sick and their families.
The LAG acknowledges
the diligence and concern for the approach of this issue by the FDA. Moreover, we appreciate the work of all the
doctors and scientists involved with the review team. We hope this process will result in a positive outcome that both
provides access to those in need while creating a more safe process for
distribution.
Sincerely,
The Lotronex Action
Group
Maria Zargo,
Coordinator
Corey Miller,
Coordinator
Tom Bell, Coordinator
Richard Fireman,
Coordinator
In Partnership with
the IBS Self Help Group
Jeffrey Roberts,
President
(About the LAG: The Lotronex Action Group is comprised of former users of Lotronex and has no affiliation with nor receives any funding from any pharmaceutical company or other organization.)