An Open Letter to
the
GlaxoSmithKline
Dr. James Palmer
Senior
Vice President
New Product Development
GlaxoSmithKline
5 Moore
Drive
Research Triangle Park, N.C.
27709
June 11, 2001
Dear Dr. Palmer:
I
have attempted to set up a meeting with you and others at GSK, through Ramona
DuBose, to discuss current issues pertaining to Lotronex. Unfortunately, it
appears you, and others in your company, are currently unwilling to speak with
senior representatives of the Lotronex Action Group. This is extremely unfortunate as we share common goals with your company. We would like access to the only medicine
that has been beneficial to those that suffer form severe diarrhea predominant
Irritable Bowel Syndrome, and I would venture to guess GSK wants to sell
Lotronex, as it has the potential to provide hundreds of millions of dollars in
revenue for the company if introduced worldwide.
The
Lotronex Action Group is extremely disappointed that GSK and the FDA have not
moved forward on this issue with greater speed due to the fact the medicine has
been removed from the market for over six months, thus, leaving all that suffer
with no effective alternative treatment.
We are also disappointed that the Public Advisory Committee meeting that
was being planned, according to the media, has now been pushed back
indefinitely. The patients in need of the medicine, the very people GSK was
selling its medicine to, are the ones being put through unnecessary suffering
while politics internal and external to GSK, FDA the media, and a variety of other
parties, prevent sincere action from taking place to restore access to the
medicine. FDA's own data shows Lotronex
to be a risk to only 1 in 700 people or 1% of those taking the medicine. However, due to the fact the view of a
minority group of FDA researchers is one of 'zero tolerance' for adverse side
affects because they view IBS as an 'inconvenience' and not a severe illness,
games are being played at the expense of the health and well being of those of
us that need the medicine.
Therefore, I would like to propose the
following short-term action on the part of GSK while efforts move forward for
'continued marketing' of Lotronex. The
medicine would be distributed as part of an 'open label safety study' in which
GSK would use some criteria, based on current discussions with FDA, as an
outline for the application to include the following conditions:
1. The
medicine will only be prescribed to those with diarrhea predominant IBS.
2. The
discussion of dosage and risks would be required by the doctor with the
patient. A waiver could be included
preventing legal action against GSK, by the patient, in the event of an adverse
side effect.
3. A doctor visit would be required monthly, at the time of a
prescription refill or bi-monthly.
During the visit, the patient would be asked questions by the physician,
as outlined by GSK, as part of the study.
That information would then be collected, analyzed and disseminated for
use at a later date.
At this juncture, an 'open label safety study',
while an expense to GSK, would be beneficial for the following reasons:
1. First
and foremost, patients in need would be allowed access to the medicine. From a Public Relations view, it can be
billed that GSK is sympathetic to the patient community and its needs.
2. Since
those participating in the study will have had the best results with the
medicine, without side effects, the data will most likely show a decrease in
the risk of use. This data could then
be presented to the FDA in addition to other data that was collected for other
purposes.
3. From a legal standpoint, it is our opinion that the return of
Lotronex with approval by the FDA, would benefit GSK greatly in its defense of
the many ongoing lawsuits resulting from the issue. The medicine would be viewed publicly as being much more safe
than previously portrayed.
The LAG has contacted senior officials in
the FDA regarding this short-term proposal and they seem very receptive to
it. With rapid effort on the part of
GSK, the medicine could be made available in less than two months. The Lotronex Action Group is committed in
our effort to gain permanent access to Lotronex. Therefore, GSK need not worry that the pressure from this patient
group will die due temporary access to the medicine.
I would also
like to add that the LAG and its members have reached many major national media
outlets, including CNN, CBS Evening News, Associated Press, The New York Times,
Reuters, USA Today and the The Wall Street Journal in our effort to turn public
opinion to the patients needs. We are fighting
GSK's battle for you, with no funding, and have made significant progress in
trying to make Lotronex the first medicine banned by the FDA, accessible again.
Dan
Rather has referred to Lotronex as "a miracle medicine". We truly believe it is.
Please
consider the proposal. Please do the
humane thing as people are suffering needlessly.
Sincerely,
Corey
Miller
Corey Miller, Coordinator
Lotronex Action Group (LAG)
Cc:
Maria
Zargo, Coordinator LAG
Tom Bell,
Coordinator LAG
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.)