[nfb-talk] Sleep Study Before Prescribing

Mon Feb 3 03:06:42 UTC 2014

AS I say, we don't know that Vanda/FDA *didn't* do sleep studies. But then
again, we don't know that they did, either.

Mike

-----Original Message-----
From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of Peter
Donahue
Sent: Sunday, February 02, 2014 5:48 PM
To: NFB Talk Mailing List
Subject: [nfb-talk] Sleep Study Before Prescribing

Good evening everyone,

    I would feel better about this whole issue if Vanda and/or the FDA would

require that a sleep study be done on potential users before the drug is 
prescribed to rule out sleep disorders.

Peter Donahue

----- Original Message ----- 
From: "Karen Rose" <rosekm at earthlink.net>
To: <mike at michaelhingson.com>; "NFB Talk Mailing List" <nfb-talk at nfbnet.org>
Cc: "NFB Talk Mailing List" <nfb-talk at nfbnet.org>
Sent: Sunday, February 02, 2014 5:05 PM
Subject: Re: [nfb-talk] Vanda, what is all the fuss about?

> Although I do not have this disorder I see no problem with their drug. My 
> beef is with their advertising agency
>
> Sent from my iPhone
>
>> On Feb 2, 2014, at 11:41 AM, "Michael Hingson" <Mike at michaelhingson.com> 
>> wrote:
>>
>> Hi all,
>>
>> I am coming into this discussion a bit late and I have tried to read many

>> of
>> the back posts before responding.
>>
>> I agree it is unfortunate that the adds aren't as positive and strong
>> concerning blindness as we would like.  I must puzzle over this since the
>> NFB has been closely interacting with Vanda for more than three years.
>>
>> As for the testing and studies Vanda asked for volunteers for nearly two
>> years.  They wanted volunteers to test the drug in a double blind study.
>> They got many volunteers and over a year ago Vanda announced that they 
>> had
>> found a good positive effect introduced by their product.
>>
>> Now Vanda is moving forward and has FDA approval under the prescribed
>> process for that to occur.  Where has everyone been?  The information for
>> all this has been on these lists as well as many other list serves.
>>
>> Vanda could do more to help show a positive image about blindness as they
>> create their adds.  So nicely contact them and make positive suggestions.
>> Also, contact our National office and suggest improvements, but please
>> recognize that Vanda has indeed proven a hypothesis it formulated and as 
>> a
>> result it created a product which can help blind people who have sleep
>> issues.  Keep in mind that this product, as with most blindness related
>> things, will have a limited market, but Vanda certainly determined that 
>> its
>> product was worth creating or it wouldn't have done so.
>>
>>
>> Best,
>>
>>
>> Michael Hingson
>>
>> -----Original Message-----
>> From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of David
>> Andrews
>> Sent: Sunday, February 02, 2014 11:00 AM
>> To: NFB Talk Mailing List
>> Subject: Re: [nfb-talk] A little concerned about this new drug aimed at
>> totally blind population
>>
>> You may consider the ads to be trivial -- but many here will not.  They
>> reflect how society feels about us, and they perpetuate antequated 
>> notions
>> of blindness and blind people.
>>
>> Dave
>>
>> At 12:36 PM 2/2/2014, you wrote:
>>> You'll have to forgive me for thinking you might not be looking at this
>>> issue with complete objectivity .  I can't imagine how I got the idea
>>> that you held antipathy for  Vanda. I guess maybe I took it
>>> wrong when    you called them snake oil salesmen.
>>>
>>> And, no, I do not have to admit  their ads take us for fools. That's a
>>> subjective issue that I want no part of. If you want to gripe about
>>> their ads, go ahead.  It wouldn't occur to me to care about something
>>> so trivial.
>>>
>>>> On 02/02/2014 09:59 AM, Mike Freeman wrote:
>>>> Hey, man! Tone down the rhetoric.
>>>>
>>>> If you read carefully one of my last messages, I admitted to you that
>>>> I stood corrected and that one of the articles did say they did a
>>>> double-blind study.
>>>>
>>>> Please do not confuse skepticism with antipathy. I don't think any of
>>>> us begrudge  Vanda Pharmaceuticals the right to develop a non-24 drug.
>>>> But their advertising hype tends to prejudice some of us against their
>>>> research in that some of us think that a truly scientific study
>>>> wouldn't appeal as much to problems of the blind in terms that are
>>>> all-too-familiar to many of us.
>>>>
>>>> Those of us with diabetes are unfortunately very familiar with
>>>> research hype
>>>> -- "they" have been going to have a cure for Type 1 diabetes "just
>>>> around the corner" for the past half-century, for example. And there
>>>> has been research here in the Pacific Northwest on the non-24 problem
>>>> since something like 1985. I remember a doctor from Oregon State or
>>>> the University of Oregon writing to Dr. Jernigan asking what we
>>>> thought of such research about that time and he replied, in effect,
>>>> that if the research was carefully done, NFB would have no problem with
>> it. IMO this is still what many of us think.
>>>>
>>>> But you'll have to admit that their advertisements seem to take us for
>>>> fools
>>>> -- not an auspicious way to win friends and influence people.
>>>>
>>>> Mike
>>>>
>>>>
>>>> -----Original Message-----
>>>> From: nfb-talk [mailto:nfb-talk-bounces at nfbnet.org] On Behalf Of Todor
>>>> Fassl
>>>> Sent: Sunday, February 02, 2014 7:08 AM
>>>> To: NFB Talk Mailing List
>>>> Subject: Re: [nfb-talk] A little concerned about this new drug aimed
>>>> at totally blind population
>>>>
>>>> Mike,
>>>>
>>>> I asked you a question. How in the world did you come to the
>>>> conclusion that the FDA approved this drug without a double blind
>>>> study? That's an important question. You should try to figure out what
>> caused you to make
>>>> such a ridiculous mistake.   Maybe you're not looking at this issue
>>>> objectively. Maybe you should try to be more careful. That's always
>>>> important but even more so when dealing with medical issues.
>>>>
>>>> All this stuff below is nothing but a smoke screen you're throwing up
>>>> to avoid admitting you shot your mouth off on a topic you know nothing
>> about.
>>>> Now, get out there, do some research about this drug, and then get
>>>> back to us if you still have something to say.
>>>>
>>>>
>>>>
>>>>> On 02/02/2014 12:31 AM, Mike Freeman 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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