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

Sun Feb 2 06:31:16 UTC 2014

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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