Exposing the LASIK Scam

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 Post subject: Rosenthal: LASIK is medicine if in patient's best interest
PostPosted: Mon Dec 26, 2005 6:56 pm 
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Is LASIK EVER in the patient's best interest? Since we know it's not can we STOP calling it medicine now?

http://www.pueblo.gsa.gov/cic_text/heal ... 8_eye.html

Ralph A. Rosenthal, M.D., [former]director of FDA's division of ophthalmic devices, says, "The agency has ruled that individual physicians can perform LASIK under the general 'practice of medicine,' if it's in the patient's best interest."


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PostPosted: Wed Feb 01, 2006 4:57 pm 
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Rosenthal retired entirely too late for some casualties. He is the bureaucrat that kept giving doctors extensions on their IDE deadlines. If the doctor was found to have a violation, he would give another month to correct the deficiency. If the next month the deficiency was not corrected, he would extend the due date to correct the deficiency. It could go on this way for months and years.

In my opinion this guy just wanted to make no waves and get out with a big fat pension and to hell with the blinded patients.


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PostPosted: Thu Feb 02, 2006 1:15 am 
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I spoke to Rosenthal on the phone once, and he showed absolutely zero compassion for LASIK casualties. When I specifically asked him about the suction ring inducing floaters, he said something along the lines of "we've never studied it". And, IMO, he really didn't seem to care.

There are many interesting statements in the panel meeting transcripts by Rosenthal. He sounds like a cover-up man in the industry's pocket, IN MY OPINION!

Remember his comment from the July, 1999 meeting when he said that the FDA can't tell a surgeon what to put in an informed consent? Well, what the FDA could do, and should have done, is put it in the labeling, and then make sure the labeling is provided to the patients. THAT is certainly within their authority.

Another of his noteworthy comments was during a phakic IOL meeting, when he was more concerned with protecting surgeons from malpractice lawsuits than with patients losing their corneas:

Quote:
DR. WEISS: And actually, we don't even have to -- and I'll defer to Dr. Rosenthal. We could just say if this was what we're trying to -- everything is a suggestion here. Even our vote is a suggestion. We could say that --
DR. ROSENTHAL: If you suggest that you put it in labeling as a suggestion, you put doctors in liability risk if they don't do it. So if it's in the labeling, and it's not done, even as a suggestion, I think it holds greater water than a suggestion.
DR. WEISS: So you might be suggesting to the malpractice attorney to take that case.
DR. ROSENTHAL: Did I make myself clear?
DR. WEISS: Malvina.
SPEAKER: You put people at medical legal risk.

And then there's the quote where he actually slipped up and admitted that the clinical trials data is always superior to real world results:

Quote:
DR. WEISS: I think we have to be careful about this best physicians talking about lack of data. I'm sure these were good docs and good surgeons, but creating this extra god-like category, I think we should take out of the discussion.
DR. BANDEEN-ROCHE: That's a point well-taken. That's a point well-taken. Nonetheless, I mean, we hardly expect better performance in the field than we do in a clinical trial.
DR. McCULLEY: You don't have data to support that statement, do you? Do you have data to support that statement? You do. Okay.
DR. ROSENTHAL: With all kinds of devices.
DR. McCULLEY: All right.
DR. WEISS: What I would then like to lead to is since there's agreement ??
DR. ROSENTHAL: Wait.
DR. WEISS: Yes.
DR. ROSENTHAL: I want to make sure I said the right thing. Once they go out in the field, they tend to have more problems than they do within the clinical trial.

_________________
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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject: Rosenthal
PostPosted: Tue Mar 07, 2006 7:32 am 
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Makes you wonder how deep his pockets were...

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http://www.lasiksucks4u2.com
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 Post subject:
PostPosted: Sat Jul 21, 2007 2:50 pm 
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Matched Population Comparison of the Visian Implantable Collamer Lens and Standard LASIK for Myopia of ?3.00 to ?7.88 Diopters

Journal of Refractive Surgery Vol. 23 No. 6 June 2007

Donald R. Sanders, MD, PhD

Quote:
It should be mentioned that data collected as part of routine follow-up as seen in the LASIK group may not have been encouraged to read the maximum lines of UCVA or BSCVA as is usually mandated in a clinical
study. This is a well-known study effect, especially at the higher visual acuity levels such as 20/20 and 20/15.

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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PostPosted: Fri Jul 27, 2007 2:05 am 
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During the review of the clinical trials for approval of phakic IOLs, Dr. Rosenthal, FDA Division Director, was not in favor of putting a statement in the labeling suggesting that doctors monitor the endothelial cell counts over a 5-year period in phakic IOL patients. Look what happens to the cell count in this study.

Outcomes of ZB5M Angle-supported Anterior Chamber Phakic Intraocular Lenses at 12 Years

Journal of Refractive Surgery Vol. 23 No. 2 February 2007

Jaime Javaloy, MD, PhD; Jorge L. Ali?, MD, PhD; Maria T. Iradier, MD; Ayman M. Abdelrahman, MD, MSc; Tomas Javaloy, MD; Fernando Borr?s, MD, PhD

Quote:
For the IOL models analyzed in this study, a constant greater loss of endothelial cell density has been found. Considering a physiological rate of decrease in the endothelial cell density of 0.56% per year, a nonoperated healthy eye would reach age 85 years with >1900 cells/mm2. For these calculations, an amortization equation for accounting
has to be used:

(formula)

where ECDi is the current cell density estimated at any moment, ECD0 is the cell density at the fi rst considered instant, and n the number of years for calculating ECDi.

As we estimate a 10.69% surgically induced decrease in the endothelial cell density in the first year and an average rate of 1.78% every year after that, a hypothetical 25-year-old patient with an endothelial cell density of 2500 cells/mm2 who received a ZB5M angle-supported PIOL would reach the advisable explantation number of 1500 cells/mm2 at age 49 years (24 years after implantation). Later enhancements in the design of these angle-supported PIOLs may reduce long-term endothelial damage. The absence of a definitive physiopathological model of endothelial injury after angle-supported PIOL implantation and the large number of eyes implanted, especially in young patients, should oblige surgeons to perform periodic endothelial cell analysis in these patients.




October 3, 2003 FDA Ophthalmic Devices Panel transcript for approval of STAAR Phakic IOL/ICL:

Quote:

DR. MACSAI: My intention was that in my hands and my practice, if I was to implant this device, which appears to be an efficacious device, we don't have an answer about the long term endothelial damage. And I, as alluded to by both Dr. Sugar, Schein and Mathers, would want to know if my patient was getting into trouble. And if they go from 28 to 2000, there's trouble right here in River City, and it's time to decide if that thing is safer in or out. And I don't want to wait until there's microcystic edema and we're transplanting that cornea in a 4 year old.
DR. WEISS: What do you recommend for labeling though? This is what you do when
DR. MACSAI: I want to suggest
DR. WEISS: You suggest, okay.
DR. MACSAI: that the practitioner follow their patients with endothelial cell counts, because that's all we have.
SPEAKER: For what time?
DR. MACSAI: Well, my personal opinion, I would say five years. And when we got all this long term data that comes in, and it shows that I'm off the wall, I'll be the first to stand up and say thank you. I'm wrong, and then we can change the labeling on the device, and that will be a wonderful thing.
DR. WEISS: Well, actually, you know, we don't even have to
DR. MACSAI: Annually for five years.
SPEAKER: Oh, annually.
DR. MACSAI: Is that what you want?
DR. WEISS: And actually, we don't even have to and I'll defer to Dr. Rosenthal. We could just say if this was what we're trying to everything is a suggestion here. Even our vote is a suggestion. We could say that
DR. ROSENTHAL: If you suggest that you put it in labeling as a suggestion, you put doctors in liability risk if they don't do it. So if it's in the labeling, and it's not done, even as a suggestion, I think it holds greater water than a suggestion.
DR. WEISS: So you might be suggesting to the malpractice attorney to take that case.
DR. ROSENTHAL: Did I make myself clear?
DR. WEISS: Malvina.
SPEAKER: You put people at medical legal risk.


Dr. Macsai apparently was so disgusted that the FDA was apparently going to approve the device without first establishing long-term safety related to endothelial cell loss that she made the following comment:

Quote:
DR. MACSAI: You may not put it in your eye, but it meets the guidance.

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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