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01/31/01 - Tom Bell to Dr. Wolfe, Public Citizen
Dear Dr. Wolfe.
I am a licensed clinical psychologist with twenty year's experience.
I am writing on behalf of the Lotronex Action Group as the Coordinator for
Professional Response. I have read the original petition and have seen the material your group has been sending in response to inquiries by citizens
and would like to know more about your thinking in regard to a couple of key questions.
I. The research itself.
A. Research on IBS itself is at what I would characterize as a
rudimentary level (see Gut 2001;48:272-282 [ February] Review: Treatment of
irritable bowel syndrome: a review of randomized controlled trials R AKEHURST, E KALTENTHALER, for a good review of the state
of the art on research). There are many reasons for this, but any action which jeopardizes this research is devastating.
B. I do agree with many of your concerns about the original
research from a scientific perspective, but I also think you are aware that
because of the difficulty in obtaining funding for scientific research and other factors, the type of research the FDA is forced to rely on is what I
would characterize as marketing research, in that it is conceived with marketing in mind rather than from purely scientific motives. This does
not mean the research itself is unscientific or invalid, but its shortcomings should also not be used against citizens who have
benefited from the drug.
II. In relation to your comments on the research, there are several
points that I think merit some discussion and evaluation:
A. Treatment of IBS (and I speak here as a patient as well as a
psychologist) often is based on vague and poorly articulated perceptions of
the patient, as that is the nature of what the patient and doctor are dealing with. There are no clear-cut scientific ways of verbalizing the sensations
the patient is having. In addition, there is no cure for IBS, so we are talking about symptom alleviation here and not cure. So it seems to me
that your characterizing the positive results of Lotronex as undefined and vague
is without much significance.
B.. It seems to me that there is some misunderstanding of what
placebo means in your criticism of the FDA. As a psychologist, and from
my knowledge of the literature, placebo effects are real, but they generally only last from six months to a year, contrary to popular conceptions.
When
you say that the effects of the drug are not effects of the drug because many of those receiving the placebo reported positive effects, I would
think you would have to look at measurement of those positive responses in the placebo group at a period at least six months after the first use,
particularly as you are referring to a possibly impressionable population and a certainly desperate population. If you had any conception of the
life these people have been living you would understand why they were grasping
at straws.
III. As I see the stories of people who have been taking Lotronex
pouring into the Lotronex mail list I think that three important facts have
been emerging which you may not have been cognizant of when you prepared your original petition.
A. IBS is in fact a severe and disabling condition, possibly more
debilitating than the public or scientific community realized prior to this
publicity.
B. There is a much higher percentage of males who received benefit
than anyone expected. This goes back to IA of course, but I do think it
[IA?] might be taken into account if you were to consider re-evaluating your original petition.
C. The majority of stories I have seen come from people who were
highly competent professional and working-class individuals who either were forced
to stop working or to carry on in a heroic battle prior to Lotronex.
Lotronex
enabled them to return to 'normal' function for a period. They are now
forced to return to their prior state. I don't think again that you were
aware of this information when you prepared your original petition.
IV. I personally am someone who has worked as an academic and as a
practitioner. I am concerned about the way the physician-patient
relationship is perceived and discussed by all parties in this issue,
particularly in the area of IBS where this sacred relationship is crucially
important. Your petition is not the only document in the many this issue has produced that does not seem to recognize this relationship for what it
is, but I think that as an advocate for citizens you do have an obligation to campaign for something that is of great potential value to all of us.
(see Beyond Diagnosis: A Landmark Survey on Depression and Its Treatment
was conducted by Schulman, Ronca and Bucuvalas, Inc)
V. I do agree with you that patient and professional knowledge of
medication and following the directions given is a major problem at present
in this country (see JAMA study, for example). It is an area where steps do need to be taken, but the stories we are getting from Lotronex users show
that they are an educated group as a whole who are very knowledgeable about the medication they are taking and cautious and careful in its use. They
don't seem characteristic of the population as a whole, but I don't think they
should be discriminated against because of this.
VI. Although with the data you had available at the time of action, your urgent supplementary letter of 10/30/2000 seems to me in light of the
information we and physicians (and I am sure you, the FDA,
and GlaxoSmithKline as well) have been receiving may well merit reconsideration. While these
are clearly not scientifically valid sources of data I am also sure that there is
enough evidence to warrant your conducting an appropriately devised survey
rather than relying on assumptions based on data that, as you yourself have
indicated, is open to question due to the nature of knowledge in the field.
In other words, we are finding out some important information in this
process about citizens, their responses to medication, and their use of medical knowledge in working with their physicians. Let us use this knowledge in a
collaborative manner for the good of all.
Thomas Bell, Psy.D. Licensed Clinical Psychologist
Member, APA, NAPT, IFFGD, Brain-Gut Research Group, IAWIS
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