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Home > Archive > Lasik Eyes Surgery > December 2004 > Would Glenn Hagele lie to the press to aid the industry in covering up LASIK problems?
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Would Glenn Hagele lie to the press to aid the industry in covering up LASIK problems?
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|
| Sandy 2004-12-18, 11:08 am |
|
Brent Hanson - LASIKFRAUD.com wrote:
> www.foxchicago.com
> http://www.lasikfraud.com/canadas_d...executives.html
>
> Part 1 of story at 9:00 p.m., Monday, December 20.
> Part 2 of story at 9:00 p.m., Tuesday, December 21
>
> I heard a rumor that the story will eventually show up nationwide on
Fox,
> but that's just speculation at this point.
>
> =====================================================
> An example of a press release from Hagele, who pretends to be a
"patient
> advocate", but who actually operates a referral service for surgeons.
> =====================================================
>
> For Immediate Release
> Saturday, 28 August 2004
> Sacramento, California, USA
>
> Patient Advocates: No Unusual LASIK Problems With Alcon LADARVision
>
> Despite accusations presented in a 28 August 2004 London Times
feature
> article suggesting that the Alcon LADARVision excimer laser used to
> perform LASIK and other refractive surgery procedures had "started
> malfunctioning, causing wildly erratic results", a nongovernmental
> organization states that it has no reports of unusual problems with
> the laser.
>
> "We have seen nothing from patients or surgeons that would indicate
> there is any systemic problem with the safety or efficacy of the
Alcon
> laser", states Glenn Hagele, Executive Director of the California
> based Council for Refractive Surgery Quality Assurance.
Here, Glenn, maybe we can refresh your memory with these comments about
the LADARvision. Sam Omar, MD and Joe Dello Russo, MD are LASIK
surgeons, and you have seen these comments of theirs previously. Are
you lying? Are you involved in covering up the transgressions of the
refractive surgery industry? Do CRSQA surgeons pay you to do this?
"Joe, i have also experienced a patient with clinically
significant decentration. Despite good photos however
in my case the clinical people at Alcon reviewed the
tracker signal data that is saved for each patient and
it looked like the tracker drifted on one of the two
eyes, the one which the patient is more symptomatic
in. The preop photos looked fine however I think there
is a weakness in how the preop photos are taken which
may increase the risk of decentration.
The company is aware of this and has had complaints
from at least me and sounds like you as well. Since
you have done 20,000 lasik at least they cant say you
are not experienced or that you dont know how to do
lasik therefore IT IS THE MACHINE. NO SUCH thing as
impossible. If they really said that to you its
complete BS. The tracker CAN DRIFT if they havent
told each and every user this verbally you can read
something about it in the user manual. You also need
to get them to teach your technician how to recognize
tracker drift mode since you will not notice this
because when you are doing the ablation it is really
the technician who is doing the surgery because they
are watching the monitor and you are watching the eye.
Unfortunately drift mode is detected by watching the
monitor not the eye."
Sam Omar MD
--- JoeDelloRussoMD@aol.com wrote:
> i wonder if any ladarvision users have experienced
> a decentration despite
> good alignment and good centration fotos. i have one
> patient like this and
> the company says it is impossible. Does anyone have
> any ideas that they would
> like to share ?
> joe dello russo
Glenn, this material was posted in this forum in April 2004, and you
responded to the post, so you can in no manner deny it. Take a look at
your response to the original posting, below:
Sandy Apr 28, 6:25 am
Newsgroups: alt.lasik-eyes
From: s...@savvysneaks.com (Sandy) - Find messages by this author
Date: 28 Apr 2004 06:25:02 -0700
Local: Wed, Apr 28 2004 6:25 am
Subject: Has Alcon fixed the problems with their Ladarvision tracker
drift?
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JoeDelloRuss...@aol.com wrote:
[vbcol=seagreen]
[vbcol=seagreen]
[vbcol=seagreen]
"Joe, i have also experienced a patient with clinically
significant decentration. Despite good photos however
in my case the clinical people at Alcon reviewed the
tracker signal data that is saved for each patient and
it looked like the tracker drifted on one of the two
eyes, the one which the patient is more symptomatic
in. The preop photos looked fine however I think there
is a weakness in how the preop photos are taken which
may increase the risk of decentration.
The company is aware of this and has had complaints
from at least me and sounds like you as well. Since
you have done 20,000 lasik at least they cant say you
are not experienced or that you dont know how to do
lasik therefore IT IS THE MACHINE. NO SUCH thing as
impossible. If they really said that to you its
complete BS. The tracker CAN DRIFT if they havent
told each and every user this verbally you can read
something about it in the user manual. You also need
to get them to teach your technician how to recognize
tracker drift mode since you will not notice this
because when you are doing the ablation it is really
the technician who is doing the surgery because they
are watching the monitor and you are watching the eye.
Unfortunately drift mode is detected by watching the
monitor not the eye.
Sam Omar MD
Glenn - USAEyes. org Apr 28, 7:05 pm show options
Newsgroups: alt.lasik-eyes
From: Glenn - USAEyes.org <glenn.hageleSTOPS...@USAEyes.org> - Find
messages by this author
Date: Thu, 29 Apr 2004 02:05:22 GMT
Local: Wed, Apr 28 2004 7:05 pm
Subject: Re: Has Alcon fixed the problems with their Ladarvision
tracker drift?
Reply | Reply to Author | Forward | Print | Individual Message | Show
original | Report Abuse
[vbcol=seagreen]
>You quoted Dr. Sam Omar MD about the Ladarvision tracking. You
>omitted the date that Dr. Omar said this. Anytime you quote someone,
>you should include the date along with it. It wasn't that long ago
>that lasers had no tracking systems. If this quote was made 2 months
>after the tracking device was put into use, then it makes sense. It
>sounds to me like you already know the problem has been fixed and you
>are just trying to stir up fear and worry.
Those of us who have been in this forum a while are familiar with this
tactic. I refer to it as SandySpam. It is sometimes relevant, but
almost always has a subject line that is inflammatory and/or is not
supported by the content of the article itself. Keller uses
disingenuous innuendo like an artist. It is her medium. A true
master.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
_________________________________________
I think it's time to ring up FOX News.
Here is a link to Glenn's original post:
http://groups-beta.google.com/group...32?dmode=source
| |
| Glenn - USAEyes.org 2004-12-18, 7:12 pm |
| The answer to Keller's inflammatory and accusational subject line is
no.
The information in our press release is accurate. We have not
received or found any information that indicates there is a systemic
problem with the Alcon LADARVision 4000 excimer laser.
When the accusations came up over a year ago I had personally talked
with several users of the Alcon laser, including users who own other
lasers. When the British press made a big stink a few weeks ago, I
again talked with several Alcon users. I've also talked with Alcon's
competitors - the people who would gain greatly by Alcon faltering -
and they have no knowledge of systemic problems with the Alcon.
The only people who have publicly stated there is a systemic problem
with the Alcon (or any) laser are two US entities that Alcon sued
because they had not paid millions in royalties. This doctor and open
access facility then counter-sued Alcon, claiming an inferior product.
Since the Alcon LADARVision 4000 was first approved by the FDA in
October 2002, study after study has been presented or published
regarding refractive surgery outcomes with the Alcon excimer laser -
including the peer-reviewed FDA clinical trials. None indicate a
systemic problem. Tens (hundreds) of thousands of patients have had
surgery with the Alcon LADARVision 4000, yet none have presented
complications that indicate a systemic problem with the laser
Not having a design flaw does not mean perfection either. Lasers are
mechanical devices run by electronics. Anyone who has driven a car or
used a computer knows that they do not always do what is desired or
expected. It is reasonable to expect that there will be occasions
when something is not going to be right, but something not right all
the time is a whole different matter.
We have a unique knowledge of the issues in this situation. The
patient outcomes of the doctor involved in the lawsuit were evaluated
by our organization for purposes of certification, so we know for a
fact that patient outcomes were at or above the national norm.
The courts will decide if there is any legitimacy to this claim, but
there are several hundred Alcon lasers installed in the US and other
doctors are not jumping on this bandwagon. I also find it quite
revealing the claims of inferior product were not made until after
Alcon sued them to collect money owed.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| Sandy 2004-12-18, 10:11 pm |
|
Glenn - USAEyes.org wrote:
> The answer to Keller's inflammatory and accusational subject line is
> no.
>
> The information in our press release is accurate. We have not
> received or found any information that indicates there is a systemic
> problem with the Alcon LADARVision 4000 excimer laser.
Okay, so a surgeon states that it is mentioned in some form or manner
in the laser operator's manual, but as far as you/CRSQA is concerned,
that still does not indicate a problem. Hmmmm.
>
> When the accusations came up over a year ago I had personally talked
> with several users of the Alcon laser, including users who own other
> lasers. When the British press made a big stink a few weeks ago, I
> again talked with several Alcon users. I've also talked with Alcon's
> competitors - the people who would gain greatly by Alcon faltering -
> and they have no knowledge of systemic problems with the Alcon.
It's possible that not all of the users of that laser have noticed the
problem.
>
> The only people who have publicly stated there is a systemic problem
> with the Alcon (or any) laser are two US entities that Alcon sued
> because they had not paid millions in royalties. This doctor and
open
> access facility then counter-sued Alcon, claiming an inferior
product.
This doctor you mention....is he Dello Russo or Omar?
>
> Since the Alcon LADARVision 4000 was first approved by the FDA in
> October 2002, study after study has been presented or published
> regarding refractive surgery outcomes with the Alcon excimer laser -
> including the peer-reviewed FDA clinical trials. None indicate a
> systemic problem. Tens (hundreds) of thousands of patients have had
> surgery with the Alcon LADARVision 4000, yet none have presented
> complications that indicate a systemic problem with the laser
But Drs. Omar and Dello Russo have noticed a problem, and it's
mentioned in the operator's manual. Hmmm.
>
> Not having a design flaw does not mean perfection either. Lasers are
> mechanical devices run by electronics. Anyone who has driven a car
or
> used a computer knows that they do not always do what is desired or
> expected. It is reasonable to expect that there will be occasions
> when something is not going to be right, but something not right all
> the time is a whole different matter.
Ahh, so as long as the majority of patients end up okay, CRSQA is okay
with that.
>
> We have a unique knowledge of the issues in this situation. The
> patient outcomes of the doctor involved in the lawsuit were evaluated
> by our organization for purposes of certification, so we know for a
> fact that patient outcomes were at or above the national norm.
The national norm. Yeah, the norm where a certain percentage of
patients come out of lasik with complications, visual problems,
thoughts or acts of suicide. Yeah, that national norm.
>
> The courts will decide if there is any legitimacy to this claim, but
> there are several hundred Alcon lasers installed in the US and other
> doctors are not jumping on this bandwagon. I also find it quite
> revealing the claims of inferior product were not made until after
> Alcon sued them to collect money owed.
And FOX News will likely decide if they smell a rat and want to chase
it.
| |
| rebeccaNO_SPAM@lasermyeye.org 2004-12-18, 10:11 pm |
| > The only people who have publicly stated there is a systemic problem
> with the Alcon (or any) laser are two US entities that Alcon sued
> because they had not paid millions in royalties.
No one has alleged that there is something wrong with every machine.
The allegations are that many of the machines have had excessively high
retreatment rates on a sustained basis and/or erratic outcomes (such as
decentrations) at unpredictable intervals.
There are two simple (and fairly obvious) explanations for surgeons not
coming forward. First, most would consider it professional suicide - to
say nothing of the legal implications as they would have to contend
with both Alcon and (potentially) their former patients. Second, few to
no newspapers would be likely to willingly risk a libel suit from a
very, very deep pocket in a highly complex situation like this unless
they had not only substantial evidence but a critical mass of surgeons
backing it. The London Times, incidentally, apparently thought they had
both: they referred to, among other things, a leaked internal document
purportedly showing excessively high retreatment rates on many
machines, a conference call transcript, and interviews with "more than
20" surgeons, of whom they only - for unknown reasons - named a few. I
heard some rumours early on that Alcon was going to sue the Times, but
nothing lately.
The "it's only people who owe us money making these allegations"
defense is a bit on the stale side. Those two parties are not the only
ones to publicly allege problems with the LADARVision. Other surgeons
have done so as well and still others' private statements have been
made public. - Furthermore, giving the massive disincentives to
speaking out on such a subject, it is in no way surprising that those
who believe they have suffered economic harm would be the first ones to
speak out.
> Since the Alcon LADARVision 4000 was first approved by the FDA in
> October 2002, study after study has been presented or published
> regarding refractive surgery outcomes with the Alcon excimer laser -
> including the peer-reviewed FDA clinical trials. None indicate a
> systemic problem.
I'd like to add a little perspective here.
First, the LADARVision was approved for PRK in 1998 (when it was owned
by Autonomous) and for LASIK in 2000 (afterit had been bought by Summit
who were then in turn bought by Alcon). The 2002 approval was
specifically for its use with the wavefront application (Custom
Cornea).
Second, no one has claimed there is a problem with every machine or a
constant problem with any one machine. As all doctors and anyone
familiar with all these studies know, the individual studies each
typically involve a small handful of machines. There are many hundreds
of these machines in use. Add together all of the machines ever used in
any peer-reviewed study, and you are looking at a small percentage of
the machines in use. Yet even then, IF the machines used in studies
were randomly selected every time AND every study undertaken was
completed AND was ultimately published, one certainly would expect the
problem to surface somewhere. But that simply isn't the case.
And you know, it might make sense to actually look at the studies
rather than simply quoting from Alcon's press release. Against all odds
there was actually a study (Dec 2003 JCRS) comparing VISX and
Ladarvision outcomes. It showed a 22% retreatment rate for moderate
myopes on the LADARVision, compared to 18% on the VISX. That's more
than double the retreatment rate for myopes in the approval documents
for the LADARVision.
> Tens (hundreds) of thousands of patients have had
> surgery with the Alcon LADARVision 4000, yet none have presented
> complications that indicate a systemic problem with the laser.
The logic and/or relevance of this escape me. No one is denying that
large numbers of patients have been treated successfully uneventfully -
this goes without saying, otherwise no one would be using the machines.
And no individual outcome of any type could prove a problem with every
laser.
> Not having a design flaw does not mean perfection either. Lasers are
> mechanical devices run by electronics. Anyone who has driven a car
or
> used a computer knows that they do not always do what is desired or
> expected.
Most people expect cars to do what is expected so long as they are
properly operated. They even expect parts of cars to do what is
expected. Or was a certain massive tire recall just a hallucination?
As to computers, well, the market can safely govern devices which -
unlike cars or lasers - have no immediate and direct safety or health
implications. So your laptop crashed. Big deal. But your laser crashed
(or seriously misbehaved in some form) during an ablation? Now THAT's a
big deal.
> It is reasonable to expect that there will be occasions
> when something is not going to be right, but something not right all
> the time is a whole different matter.
Profound.
If all or even any of the machines were working wrong ALL the time,
obviously they never would have lasted a day in clinic let alone the
market.
> We have a unique knowledge of the issues in this situation. The
> patient outcomes of the doctor involved in the lawsuit were evaluated
> by our organization for purposes of certification, so we know for a
> fact that patient outcomes were at or above the national norm.
According to CRSQA's website you evaluate 250 consecutive cases. I
don't know what percentage that is of the doctor's total cases in a
year, but we're clearly talking single digits - of consecutive, not
random, patients. I am not qualified to make statements about the
doctor's outcomes and I will not do so. And unless your certification
process is different than advertised, YOU are not qualified to make the
statement "we know for a fact that patient outcomes were at or above
the national norm" unless there is an implied "at least some of the"
before the phrase "patient outcomes" in both sentences of the preceding
paragraph.
> The courts will decide if there is any legitimacy to this claim
Quite right. Have you read any of the expert testimony lately?
| |
|
|
| Glenn - USAEyes.org 2004-12-20, 2:08 am |
| For brevity, I've snipped bits here and there.
>No one has alleged that there is something wrong with every machine.
In fact, that is exactly what has been alleged. The London Times
specifically alleged that Alcon had a problem that affected certain
models/serial numbers, and the defendants in the two lawsuits are
claiming that each machine owned by the two of them were flawed.
>There are two simple (and fairly obvious) explanations for surgeons not
>coming forward. First, most would consider it professional suicide - to
>say nothing of the legal implications as they would have to contend
>with both Alcon and (potentially) their former patients.
Give me a break, Rebecca. It would take two phone calls for the owner
of an Alcon to have it taken away and purchase another one. If the
problems were as alleged, doctors would do this for exactly the same
liability reasons you state they would not. If the problems were as
alleged, Alcon would have little recourse but to remove the laser
without delay or penalty.
In fact, if the two defendants had paid their royalties, Alcon would
have removed their lasers and there would have been nothing more said.
It was only when Alcon sued these two for collection of unpaid
royalties that accusations of flawed lasers were made.
>Second, few to
>no newspapers would be likely to willingly risk a libel suit from a
>very, very deep pocket in a highly complex situation like this unless
>they had not only substantial evidence but a critical mass of surgeons
>backing it.
Although it is a speculative assumption, the lack of such news stories
indicates that there is neither substantial evidence or a critical
mass of surgeons backing the accusations. No matter how you look at
it, we are talking about a small number of users making these serious
allegations. Only two are doing so in the courts, and that is only
after being sued by Alcon for the collection of millions of royalties.
>The "it's only people who owe us money making these allegations"
>defense is a bit on the stale side.
Stale? If it is true, it does not have an expiration date.
>Those two parties are not the only
>ones to publicly allege problems with the LADARVision. Other surgeons
>have done so as well and still others' private statements have been
>made public. -
There are surgeons who report undesired outcomes on every piece of
medical equipment out there. This is because we are talking about
surgery, with all the limitations that implies. There is no perfect
medical device, no perfect surgeon, no perfect surgery. Perfection in
medicine does not exist.
>Furthermore, giving the massive disincentives to
>speaking out on such a subject, it is in no way surprising that those
>who believe they have suffered economic harm would be the first ones to
>speak out.
If this was the public health issue they now allege, you would think
they would have spoken out sometime before they were sued for lack of
payment of royalties. As long as Alcon let them use the laser and was
not collecting the royalties, they used the laser. No problem. If
these allegations are true, then these folks knew they had a defective
medical device, yet continued to use it on new patients right up until
Alcon demanded they pay the royalties. Talk about crossed
liabilities!
>Second, no one has claimed there is a problem with every machine or a
>constant problem with any one machine.
Actually, that is what has been claimed in one form or another.
>As all doctors and anyone
>familiar with all these studies know, the individual studies each
>typically involve a small handful of machines. There are many hundreds
>of these machines in use. Add together all of the machines ever used in
>any peer-reviewed study, and you are looking at a small percentage of
>the machines in use. Yet even then, IF the machines used in studies
>were randomly selected every time AND every study undertaken was
>completed AND was ultimately published, one certainly would expect the
>problem to surface somewhere. But that simply isn't the case.
So then we agree. The peer-reviewed and published studies do not
provide any indication that there is a systemic problem with the Alcon
LADARVision. Maybe something else could be argued for this fact, but
the fact is that there is nothing in patient outcome studies that
indicates there is any sort of systemic problem with the Alcon laser.
>And you know, it might make sense to actually look at the studies
>rather than simply quoting from Alcon's press release.
If you are referring to me, I have not seen an Alcon press release on
this issue, so it is impossible for me to quote it. Our press release
is based on our information.
>Against all odds
Why would there be odds that there would be a study comparing lasers?
That is standard fare.
>there was actually a study (Dec 2003 JCRS) comparing VISX and
>Ladarvision outcomes. It showed a 22% retreatment rate for moderate
>myopes on the LADARVision, compared to 18% on the VISX. That's more
>than double the retreatment rate for myopes in the approval documents
>for the LADARVision.
Following is a portion of the abstract on this study. Please note
that these are NOT wavefront-guided lasers. All ablations were
conventional.
~~~~
Title:
Comparison of LADARVision and Visx Star S3 laser in situ
keratomileusis outcomes in myopia and hyperopia
Purpose:
To compare visual outcomes with 2 commonly used excimer lasers, the
Autonomous LADARVision (LV) (Alcon Laboratories Inc.) and the Visx
Star S3 (S3), in the performance of myopic and hyperopic astigmatic
laser in situ keratomileusis (LASIK).
Conclusion:
The LV and S3 lasers yielded equivalent results in myopic LASIK
between 0 and -6.00 D; however, the LADARVision yielded statistically
significantly better results in hyperopic LASIK between +1.00 and
+6.00 D.
J Cataract Refract Surg 2003; 29:2351–2357 © 2003 ASCRS and ESCRS
~~~~~
Now, let's talk about the difference in retreatment rates between the
Visx Star S3 and the conventional Alcon LADARVision lasers. In this
study, 100 eyes (not patients) were treated with each machine. A 22%
retreatment rate means that 22 eyes needed retreatment with the Alcon.
An 18% retreatment rate with the Visx means that 18 eyes needed
retreatment. So in this study there is a total retreatment difference
between the Visx S3 and the LADARVision of 3 eyes.
Here is an obvious reason for the three eye difference. 41 of the
Alcon eyes were hyperopes, compared with 25 of the Visx eyes being
hyperopes. Everyone, including the manufacturers, doctors, CRSQA, and
this study, states that hyperopic correction is much less predictable
than myopic and is much more likely to require enhancement surgery.
In this study the LADARVision was found to be statistically better at
treating hyperopes than the Visx, but the significantly higher number
of hyperopes could easily explain the 3 eye difference.
Everyone considering refractive surgery needs to remember that it is
not always the 20-Minute Miracle that the ads profess, but is often
more of a six-month process that may include the need for enhancement
surgery to 'fine tune' the results. The evidence in this report
indicates that the LADARVision is equal to the Visx, but superior if
you are a hyperope.
Not only does it make sense to look at the studies, it is equally
helpful to do so with an open mind.
>
>The logic and/or relevance of this escape me. No one is denying that
>large numbers of patients have been treated successfully uneventfully -
>this goes without saying, otherwise no one would be using the machines.
>And no individual outcome of any type could prove a problem with every
>laser.
What apparently escapes you is that if the defendants in the two
lawsuits are to be believed, every one of their multiple lasers (I
believe it was 7 total) were defective. Patient outcomes are not
consistent with this accusation.
>or
>
>Most people expect cars to do what is expected so long as they are
>properly operated. They even expect parts of cars to do what is
>expected. Or was a certain massive tire recall just a hallucination?
I think you just proved my point.
>As to computers, well, the market can safely govern devices which -
>unlike cars or lasers - have no immediate and direct safety or health
>implications. So your laptop crashed. Big deal. But your laser crashed
>(or seriously misbehaved in some form) during an ablation? Now THAT's a
>big deal.
Darn right! If it was happening all the time or if there was an
inherent flaw that made the software unreliable, then we would all be
lining up to hang the perpetrators by the toes.
>If all or even any of the machines were working wrong ALL the time,
>obviously they never would have lasted a day in clinic let alone the
>market.
Then you apparently do not agree with at least some of the accusations
made by the defendants.
>
>According to CRSQA's website you evaluate 250 consecutive cases.
Actually, 125 consecutive patients. That may or may not be 250 eyes
because some may need treatment in only one eye.
>don't know what percentage that is of the doctor's total cases in a
>year, but we're clearly talking single digits - of consecutive, not
>random, patients. I am not qualified to make statements about the
>doctor's outcomes and I will not do so. And unless your certification
>process is different than advertised, YOU are not qualified to make the
>statement "we know for a fact that patient outcomes were at or above
>the national norm" unless there is an implied "at least some of the"
>before the phrase "patient outcomes" in both sentences of the preceding
>paragraph.
I don't really think qualifying statements are necessary, but if you
want to you could say that because we have evaluated one of the
defendants in this case and know, based upon the scope of our
evaluation, that the outcomes were at or above the national norms.
Seems like splitting hairs to me.
>Quite right. Have you read any of the expert testimony lately?
Whose? Alcon's or the defendants? As is almost always the case, one
counters the other almost equally. As much as I am interested in the
evidence put forth by all parties, I am even more interested in the
final result.
Rather than getting sucked in to the countering claims, I prefer to
talk with users, competitors, and look at patient outcomes. After
all, I think even you, Rebecca, would agree that what is most
important is the patient outcomes. No one, not you, not the
defendants, not the London Times, not anyone, has come up with the bad
patient outcomes that would be consistent with the accusations being
made.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| Glenn - USAEyes.org 2004-12-20, 2:08 am |
| >Okay, so a surgeon states that it is mentioned in some form or manner
>in the laser operator's manual, but as far as you/CRSQA is concerned,
>that still does not indicate a problem. Hmmmm.
There are many limitations mentioned in the laser operator's manual.
In fact, that is the primary purpose of the manual. What the laser
does or does not do that is consistent with the manual is exactly what
the FDA has evaluated and approved. Our primary concern is not what
is in the manual, but the patient outcomes. There are no published
reports of patient outcomes that indicate a systemic problem with the
Alcon laser. There is nothing in the patient outcomes we have
directly evaluated that indicates a systemic problem with the Alcon
laser, and that includes the outcomes of one of the defendants in the
lawsuit.
>
>It's possible that not all of the users of that laser have noticed the
>problem.
A systemic or manufactured flaw would be consistent across all models
of a particular item. It seems inconceivable that others would not
have noticed, but I suppose even the inconceivable is possible.
>open
>product.
>
>This doctor you mention....is he Dello Russo or Omar?
Neither.
>
>But Drs. Omar and Dello Russo have noticed a problem, and it's
>mentioned in the operator's manual. Hmmm.
The issues raised in the pilfered email group conversations are not
the same as the primary accusations by the two who have been sued by
Alcon for collection of royalties. It would do them little good to
claim there is a problem when that limitation has already been
evaluated, approved by the FDA, and documented in the labeling. All
doctors must work within the limitations defined and approved by the
FDA.
>or
>
>Ahh, so as long as the majority of patients end up okay, CRSQA is okay
>with that.
What we would be okay with is every patient having a perfect outcome
every time with no healing, no pain, and for no money, but that is not
the real world. We focus on the real world outcomes of patients. To
be certified by our organization, a surgeon must meet or exceed the
national norms for patient outcomes. Yes, we are okay with outcomes
that are above the norm.
>
>The national norm. Yeah, the norm where a certain percentage of
>patients come out of lasik with complications, visual problems,
>thoughts or acts of suicide. Yeah, that national norm.
We don't create the national norm of patient outcomes, we report it
and respond appropriately. It is the norm, with all its consequences.
One of the reasons we make the norm such a central part of our website
is for people considering refractive surgery to have a reasonable
understanding of the risks involved so they can make an informed
decision. If the norm is not acceptable, then the person should NOT
have refractive surgery. If a person has an expectation of an outcome
that is above the norm, then that person very likely has an
unreasonable expectation.
>
>And FOX News will likely decide if they smell a rat and want to chase
>it.
I have no knowledge of what a Chicago Fox affiliate news article is
about, or if it even exists. If it is about the two lawsuits where
someone is accusing a laser made for eye surgery as having an inherent
flaw, it most certainly would make for a sensational story, whether or
not the accusations are justified.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
| |
| Glenn - USAEyes.org 2004-12-20, 2:08 am |
| Whoops! That is a 4 patient difference between the Visx and
LADARVision, not 3.
| |
| rebeccaNO_SPAM@lasermyeye.org 2004-12-20, 4:07 am |
| Glenn,
Nice job. Go on wordsmithing this to death - precisely as anticipated.
At the end of the day, you will find you have backed the wrong horse.
| |
| Glenn - USAEyes.org 2004-12-20, 7:17 pm |
| >Nice job. Go on wordsmithing this to death - precisely as anticipated.
One should always anticipate that I will dispute unprovable and
apparently inaccurate allegations about refractive surgery issues and
articulate them the best I am able.
>At the end of the day, you will find you have backed the wrong horse.
Ah yes, the "someday I'll be proven right" response. That was
anticipated too.
The only horse I'm backing is all the internal and external evidence
that shows there is nothing systemicly wrong with the Alcon
LADARVision 4000 excimer laser in either conventional or
wavefront-guided mode. The laser has limitations and no surgery is
perfect, but there are no hidden design flaws as alleged.
Perhaps someday these claims against Alcon's laser will be proven
right, but you are fanning the flames now, when you cannot offer any
unbiased evidence that you are right. My "wordsmithing" is simply
presenting fact after fact that not only dispute the claims you appear
to be so desperately clinging to, but also show the citations you use
to prove your point to actually prove the opposite.
Perhaps someday there will be real untainted evidence that shows
otherwise, but until then I stand by the patient outcomes, which in my
opinion are the only thing that really matters.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
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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