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

Sun Feb 2 22:39:34 UTC 2014

Dave et al,

I believe you are correct in your guessing they were surprised at the fast
track.  The study my wife is in ends for her in September of this year.  She
has had extremely good results from ther drug and has no desire to go back
to the way things were.  She lives a very hectic life right now, and there's
no way she could do it if she still was dealing with this disorder.  

Loren 

-----Original Message-----
From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of David
Andrews
Sent: Sunday, February 02, 2014 10:48 AM
To: NFB Talk Mailing List
Subject: Re: [nfb-talk] A little concerned about this new drug aimed at
totally blind population

My information may not be correct, but I am told that even Vanda was
surprised by the fast track.  They expected the studies to go on for another
year.

Dave

At 12:31 AM 2/2/2014, you wrote:
>Sir:
>
>I sit corrected about a double-blind study and am glad to be informed.
>However, I assure you that FDA isn't always as careful as you might
believe.
>The announcement itself gives some indication of this in that FDA 
>fast-tracked experimental use of this drug, presumably because of the 
>blindness angle. And be assured that until various specialists in 
>statistical medicine and epidemiology insisted otherwise, the original 
>trial of the Salk poleo vaccine was going to be a single-blind, not a 
>double-blind study. But wiser heads prevailed so it was a full 
>pluscebo-controlled, double-blind study with something like fifty 
>thousand participants -- enough to give truly valid statistical results.
>
>And way back in 1936,Dilantin was fast-tracked for epilepsy control 
>because at that time, it was about the only drug other than 
>phenobarbital that was effective.
>
>And can you say viox or celibrex? Or Avandia, which was originally 
>approved, then got a strong warning label and now has been shown 
>largely not to merit that label?
>
>We're all (including scientists and medical personnel) human.
>
>Cheers!
>
>Mike
>
>
>-----Original Message-----
>From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of Todor 
>Fassl
>Sent: Saturday, February 01, 2014 4:50 PM
>To: NFB Talk Mailing List
>Subject: Re: [nfb-talk] A little concerned about this new drug aimed at 
>totally blind population
>
>Mike,
>
>How in the world did you come to the conclusion that no double-blind 
>studies have been done? That's *crazy*. The FDA doesn't approve drugs 
>w/o double blind studies. No wonder people accuse you of not knowing 
>what you are talking about.  This is so typical of your behaviour. You 
>never seem to care whether you know  the first thing about a subject 
>before shooting your mouth off. Do you realize how irresponsible you 
>are being? This is a medical issue, What the f**k do you know about
medicine?
>
>Here's a link to an article that specifically mentions a double blind 
>study that was done:
>http://www.sciencedaily.com/releases/2013/06/130617142045.htm
>
>
>
>
>
>
>On 02/01/2014 05:37 PM, Mike Freeman wrote:
> > Steve:
> >
> > Obviously, I agree with you on all counts.
> >
> > In addition, while at the national Center, I heard a number of ads 
> > pushing hetlioz and I found it amusing that they start out with a 
> > supposedly blind person saying: "You can't see me because this is 
> > radio. I can't see you because I'm totally blind." AS if he wasn't also
on the radio!
> >
> > While not denying that some may find the drug helpful, I must say 
> > that,
>like
> > you, I do not think nearly enough work has been done using controls 
> > and
>I'd
> > bet good money that no pluscebo-controlled, double-blind studies 
> > have been done.
> >
> > Mike Freeman
> >
> >
> > -----Original Message-----
> > From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of 
> > Steve Jacobson
> > Sent: Saturday, February 01, 2014 2:24 PM
> > To: NFB Talk Mailing List
> > Subject: Re: [nfb-talk] A little concerned about this new drug aimed 
> > at totally blind population
> >
> > Hi,
> >
> > I have also been uneasy about all of this, but I recognize I don't 
> > know
>all
> > there is to know about all this.  Because One is blind and doesn't 
> > seem to have a sleep problem like this doesn't mean nobody does.
> > Because ablind person has a sleep disorder doesn't mean it is 
> > related to blindness, either.  I have seen firsthand where sleep 
> > clinics dealing with
>a
> > blind person assume the problems are related to blindness without 
> > running normal tests.  I've seen doctors actually get excited like 
> > little kids when they think they have a blind person with a sleep
problem.
> > It also appears that the drug Vanda has has now been approved and 
> > was put on a sort of fast track because it deals with a rare and 
> > severe condition.  Blind people will have a disservice done if this
>drug
> > is prescribed before a thorough evaluation is performed to analyze 
> > serious sleep disorders.  I also think that painting blind people
>in
> > their mass-marketing efforts as struggling to stay awake all day is 
> > not helpful in our efforts to get jobs.  There have been other 
> > marketing efforts, though, where people have not been paid, so I 
> > don't know if that
>is
> > Vanda or not.
> >
> >
> > I will forward the note I received regarding the approval of this drug.
>I'm
> > afraid I had to laugh a little when I saw that one side-effect is 
> > drousiness.  I want to be clear, though, that I do not claim that 
> > there
>are
> > not people with serious disorders who may be helped.  I also can't 
> > say
>that
> > I know for certain that this particular disorder doesn't exist.  I 
> > just think we need to be sure that we are not stereotyped into this 
> > disorder in a way that leaves other disorders undiagnosed.  We also 
> > need
>to
> > recognize that for such research to be real accurate, a control 
> > group who
>is
> > not blind but shares other similarities, such as the same 
> > unemployment rate, would need to have been used, and I have not been 
> > convinced that was done in the reading I've done, but I don't claim 
> > I've read every word of every study.
> >
> > Best regards,
> >
> > Steve Jacobson
> >
> > On Sat, 1 Feb 2014 13:48:39 -0800, Mike Freeman wrote:
> >
> >> Beth:
> >> I absolutely agree with you! Although a few blind folks may have a 
> >> sleep disorder (I know of one such person), so do many sighted 
> >> people and it is
> > my
> >> experience that when most blind persons with sleeping problems are 
> >> put on
>a
> >> regular schedule (i.e., no odd hours, working a nine-to-five day, 
> >> etc.)
>and
> >> get enough vigorous exercise, either on the job or as a program, 
> >> their
> > sleep
> >> problems disappear. For example, I know a lady who used to have 
> >> sleep problems when she wasn't working. But when she started 
> >> working a regular
> > day
> >> at a Head Start program, up and down all day with the kids, miracle 
> >> of miracles, her sleep problem disappeared!
> >> So I'm very much a doubter. Trouble is that when I voice such 
> >> skepticism with much vigor, I get a lot of push-back from other 
> >> blind people (both
>in
> >> ACB and NFB),maintaining I don't know what I'm talking about.
> >> Also, I know a couple of people who are participating in their 
> >> so-called studies and haven't received payment yet.
> >> Can you say "snake-oil"?
> >> Mike Freeman
> >>
> >> -----Original Message-----
> >> From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of 
> >> beth.wright at mindspring.com
> >> Sent: Saturday, February 01, 2014 1:33 PM
> >> To: nfb-talk at nfbnet.org
> >> Subject: [nfb-talk] A little concerned about this new drug aimed at
>totally
> >> blind population
> >> Hi, folks. Just wanted to see if I could get the scoop on this new 
> >> drug that's supposed to correct the sleep/wake cycles in people who 
> >> are
>totally
> >> blind. I'm totally blind myself, but haven't had any problems with 
> >> my
>sleep
> >> patterns, so, even though I've seen lots of ads for it on
>blindness-related
> >> web sites and know that they've been a major sponsor at our 
> >> conventions,
>I
> >> wasn't all that concerned about it one way or the other. As far as 
> >> I can tell, their ads have been pretty tastelike and their 
> >> recruitment
> > techniques,
> >> fairly low key. Lately, though, they seem to be ramping up the message.
> > From
> >> what I can tell, they now seem to be claiming that this sleep/wake 
> >> thing
>is
> >> a serious problem, affcting around eighty thousand people in the 
> >> US, the majority ofthe totally-blind population. I think that's 
> >> deceptive. I know that they need to reach the largest number of 
> >> people possible in order to make a sufficient profit, but I don't 
> >> think they should exaggerate the seriousness of this s o-called 
> >> disorder.

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