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

[David Andrews]

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.