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Home > Archive > Lasik Eyes Surgery > July 2005 > CLINICAL TRIALS FOR LASIK FLAWED
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CLINICAL TRIALS FOR LASIK FLAWED
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| Fernando 2005-06-29, 10:54 pm |
| CLINICAL TRIALS FOR LASIK FLAWED
On the subject of LASIK complications, and who knew what and when...let's
just say I can't wait for some depositions to go public.
Here's something that is public that may interest you. Hopefully you have
read it. If you have, you would know that there was a BIT of a clinical
trials problem, with VISX being much more, shall we say 'problematic' than
Alcon. Now there's an understatement.
Now why do you think a company would collect contrast sensitivity data and
not report same? Hint, LASIK causes loss of contrast sensitivity in all
patients. Don't want to have to actually tell the victims, er... I mean
'patients' about that, so suppress THOSE DATA!!!
Hard to believe that less than 25% of LASIK patients in a clinical study
would bother to show up for their follow-up appointments! It is in their
medical best interests to be followed for a year. What do you think that
huge patient population gone missing has in common? What do you think the
patients who were included had in common? Why do you think they lied about
12 month accountability? If you were to derive means of several metrics of
outcome measure, do you think the differences between these groups would be
statistically significant?
How about patients who report being dropped from clinical trials for having
bad outcomes?
Why the reliance on subjective survey data of symptoms when the technology
to gather objective clinical data was available? And then to present
inferior subjective survey data on only a subset of patients... in a format
that any Stats 101 dropout drooling idiot can easily recognize as bad
science! Who set up these 'studies', who was monitoring these clinical
trials, who was involved in these clinical trials, and who voted to approve
these devices?
If your choices in a subjective survey are on a 'better' or 'worse' scale
with no actual measure of magnitude, then a patient who sees starbursts that
are a bit larger after surgery is scored the same way as the patient who is
incapacitated by starbursts from headlights that are larger than the cars
that generate them. How much sense does this make?
If you own, operate or participate in another website, please repost this
post including the reference below. Liberally. All over the internet.
http://www.ncbi.nlm.nih.gov/entrez/...3980&query_hl=2
J Refract Surg. 2004 Sep-Oct;20(5):S588-92.
Understanding pre-market approval and labeling differences of two leading
customized ablation platforms: a call for reform at the FDA.
Wachler BS, Hiatt JA.
Boxer Wachler Vision Institute, Beverly Hills, CA 90210, USA.
bbw@boxerwachler.com
PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market
approval reported data for two currently available wavefront-guided excimer
laser systems. METHODS: VISX and Alcon myopic wavefront laser in situ
keratomileusis (LASIK) trials were analyzed based on public information
available in the pre-market approval documents. RESULTS: Clinical tests and
outcomes reporting varied between pre-market approvals. One pre-market
approval reported contrast sensitivity whereas the other did not, although
data was collected in both studies. Based on the FDA definition of
"accountability," one pre-market approval reported 12-month accountability
of 97.7% although only 24.5% of patients were analyzed at that interval. One
pre-market approval reported 6-month results whereas the other reported 6-
and 12-month results. One pre-market approval reported grouped pre- and
postoperative subjective survey results; the other reported individual
changes in pre- to postoperative subjective symptoms. CONCLUSION: We
recommend an FDA revision to the definition of "accountability" and also
recommend future FDA refractive surgery trials be guided by standardized
criteria.
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| Glenn - USAEyes.org 2005-06-29, 10:54 pm |
| Talk about twisting things to suit your own agenda.
Dr. Boxer Wachler's report is calling attention the inconsistency of
FDA clinical trials ACROSS DIFFERENT PLATFORMS. He does not state that
the individual trials are flawed.
The concern is that a lay person reading the FDA clinical trial
outcomes of different excimer lasers cannot easily compare the
different systems. One trial had a different consistency in follow up.
Another had only low and moderate refractive error. The differences
are significant.
The report does NOT state that the individual trials are flawed, but
does complain that they are different enough that they are not easily
compared.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| serebel 2005-06-29, 10:54 pm |
|
Glenn - USAEyes.org wrote:
> Talk about twisting things to suit your own agenda.
>
Me thinks Fernando is seeing gollywoggles under the bed again.
SErebel
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| Fernando 2005-07-03, 12:35 pm |
| Methinks SEreble can't see since his LASIK surgery and has a horrible case
of denial...
"serebel" <serebel@aol.com> wrote in message
news:1120094053.728209.238590@g49g2000cwa.googlegroups.com...
>
>
> Glenn - USAEyes.org wrote:
>
>
>
> Me thinks Fernando is seeing gollywoggles under the bed again.
>
>
> SErebel
>
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| Fernando 2005-07-03, 12:35 pm |
| Twisting things is your game, Glenn.
EXAMPLE OF FLAW:
"one pre-market approval reported 12-month accountability
of 97.7% although only 24.5% of patients were analyzed at that interval."
This is a lie, lose-your-job/license sort of stuff.
You know there are problems with LASIK, but keep denying them to make
personal profit - at the expense of harm to the public.
Consider and choose with confidence? What kind of an idiotic slogan is that?
The only choice about LASIK you can make with confidence is NOT TO HAVE
IT. You can be sure of the outcome of that decision. LASIK is a gamble and
you know it.
"Glenn - USAEyes.org" <glenn.hageleSTOPSPAM@USAEyes.org> wrote in message
news:jle6c1lcv8ttt9g43icphrsuvdgpe61po2@4ax.com...
> Talk about twisting things to suit your own agenda.
>
> Dr. Boxer Wachler's report is calling attention the inconsistency of
> FDA clinical trials ACROSS DIFFERENT PLATFORMS. He does not state that
> the individual trials are flawed.
>
> The concern is that a lay person reading the FDA clinical trial
> outcomes of different excimer lasers cannot easily compare the
> different systems. One trial had a different consistency in follow up.
> Another had only low and moderate refractive error. The differences
> are significant.
>
> The report does NOT state that the individual trials are flawed, but
> does complain that they are different enough that they are not easily
> compared.
>
> Glenn Hagele
> Executive Director
> USAEyes.org
>
> "Consider and Choose With Confidence"
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
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| Glenn - USAEyes.org 2005-07-03, 12:35 pm |
| I invite everyone to read the actual report, or better yet, contact
Dr. Boxer Wachler directly and ask him. I did.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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| serebel 2005-07-03, 10:53 pm |
| Okay Fernando, you win, you know me better than me. I can't see a
thing. It's all an illusion.
SErebel
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| gospa68@aol.com 2005-07-20, 2:12 pm |
| Glenn,
Welcome me back! 
I have been out of the country doing research.
I can see that nothing has changed since I left. 
Yes, Brian points out the problems of data collection across two
platforms as you have indicated. But in doing so, he also is pointing
out the problems of both studies...particularly when compared to
industry sponsored studies. The CRS studies are an embarrassment for
all. These will show up in court soon...
WizKid
Glenn - USAEyes.org wrote:
> Talk about twisting things to suit your own agenda.
>
> Dr. Boxer Wachler's report is calling attention the inconsistency of
> FDA clinical trials ACROSS DIFFERENT PLATFORMS. He does not state that
> the individual trials are flawed.
>
> The concern is that a lay person reading the FDA clinical trial
> outcomes of different excimer lasers cannot easily compare the
> different systems. One trial had a different consistency in follow up.
> Another had only low and moderate refractive error. The differences
> are significant.
>
> The report does NOT state that the individual trials are flawed, but
> does complain that they are different enough that they are not easily
> compared.
>
> Glenn Hagele
> Executive Director
> USAEyes.org
>
> "Consider and Choose With Confidence"
>
> Email to glenn dot hagele at usaeyes dot org
>
> http://www.USAEyes.org
> http://www.ComplicatedEyes.org
>
> I am not a doctor.
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| serebel 2005-07-20, 2:12 pm |
| Welcome back Wizzer. I hope you have some new outdated and obsolete
"studies" for us here.
SErebel
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| Glenn - USAEyes.org 2005-07-20, 2:12 pm |
| Dr. Boxer Wachler's concerns are indeed valid, but by not stretch of
the imagination is he stating that the FDA system is systemically
flawed, as was presented in this thread.
I think anyone who has had more than a fleeting experience with the
FDA can make many valid complaints.
Glenn Hagele
Executive Director
USAEyes.org
"Consider and Choose With Confidence"
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
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