[nfb-talk] A little concerned about this new drug aimed at totally blind population

[Heather Field]

Hello all,
I am not asserting that there are not blind people who have sleep disorders. 
Nor am I
denying that some may find this drug helpful. However, there are some very 
real problems
with what this drug company is claiming. Perhaps the most worrying of all is 
their claim that,
because totally blind people cannot see light, their physical functioning is 
not influenced by
that light. This claim is completely false. I know of numerous totally blind 
children and adults
who have experienced trouble sleeping, or who have suffered from Seasonal 
Affective
disorder, and have responded dramatically to light therapy. They simply 
spend a specified
amount of time each day, sitting in the light from the special, extremely 
bright lamps, just as
sighted people with these problems also do, and symptoms are gone. Even 
though the blind
people cannot take in the light through their eyes, they experience complete 
relief from the
symptoms. This fact, that blind people respond to bright light therapy, 
challenges the validity
of the premise on which this whole study and the subsequent need for the 
drug they've
developed, is based.

Furthermore, in the entire time this research has been going on, I have 
never read any
reports regarding the prevalence of sleep disorders among totally blind 
people who live in
countries that do not have the dark and cloudy, cold winters experienced in 
the United
States. Are there lots of totally blind people with sleep disorders in 
Australia, Indonesia,
Africa and South America, and all the various countries on or near the 
equator, where winter
is a season of long, sunny days, or where there is no winter at all?  Or are 
sleep disorders among
the blind in these areas no more common among the sighted? Doctors know that 
Exposure
to sunlight results in the body producing vitamin D. Has anybody studied 
whether sighted
people wearing sleep shades still produce the same amounts of vitamin D as 
those who
also see the sunlight? Do the eyes need to see the sunlight for the body to 
create the
vitamin d? There are a lot of unanswered questions and, importantly, a lot 
of money to be
made by not questioning certain assumptions about totally blind people and 
whether bodies
are affected by light that is not visually perceived.

Claims about the inability of the blind to stay awake or be alert on the job 
without this drug
have the potential to be extremely damaging, despite the apparent problems 
with the
research study itself. Do you think the average employer will consider the 
below problems
with this study?

main problems.
1. Sample size.
The sample size must be large enough to allow for generalisable conclusions 
to be drawn.
According to their press release, This drug has only been trialed on one 
hundred and four
people with the disorder. Surely they can find more people to trial the drug 
on if there are at
least one hundred thousand people with the problem, as they claim. How can 
they
generalise from the experiences of only 104 people?

2. A control group.
For the research findings to be truly reliable, a control group of totally 
blind subjects,
matched in at least age and gender, and who also have the non-24 hour sleep 
disorder,
would need to have been organised. Whether they were given nothing, or a 
placebo is a
variable that would need to be decided. However, all participants would need 
to have been
tested for baseline sleep and awake times, variations etc. Then, the 
intervention would
need to have been given and, finally,  the sleep and awake behaviours of the 
two groups
would need to have been compared. They would need to report the variables 
they were
studying, such as amount of time spent in restful sleep, the amount of alert 
wakeful hours,
the amount of focused attention span etc., and then prove that the drug 
taking subjects
improved on these variables by a statistically significant amount, whereas 
those in the control

group did not. The lack of a control group makes the research much less 
reliable. Of course,
this is always the problem when researchers try to study issues in the blind 
population.
They always have trouble finding a large enough sample, let alone enough 
blind people to
make an equally large control group. So, they go ahead and generalise 
anyway.

3. Controlling for variables.
The study needs to control for variables that may interfere with the 
results. As has already
been discussed on this list, there are a large number of variables that can 
cause sleep
disorders among blind people. This is the weakest area in this study. There 
are so many
things that can be causing the blind participants to have sleep problems. 
Lack of exercise,
stress and other, undiagnosed sleep disorders are the obvious ones. However, 
there are
many others. Age of participants, overall physical health, gender, 
medications, diet, level of
physical or mental activity, even the season, to name just a few. For anyone 
to take the
research seriously, these variables would need to have been taken into 
account. Variables
which are easily manipulated, such as amount of physical and mental 
activity, dietary
intake, stress level etc. needed to have been altered and further study of 
the drugs
effectiveness under these differing circumstances needs to have been done, 
before the
results could be considered reliable.

Until we see the whole report we can only speculate but, it looks like the 
research study is
not reliable, and that FDA has been mislead about the prevalence of this 
very specific sleep
disorder, as well as this drug being the urgently needed, only available 
cure for the problem.
It will be interesting to see what eventuates. Will the medical profession 
apply the normal
rigorous standards of investigation and replication when assessing the 
reliability the claims
of this initial study? Or will these results be accepted without question 
and generalised to
paint all blind people with the same sleep disorder brush? I'm afraid I'm 
not confident the
outcome will be good for blind people.
Regards,
Heather