This site describes the failure of the Ophthalmic Devices Panel of the FDA to ascertain that LASIK was safe before approving it, and other revealing information about the LASIK money-machine. 

We begin with a little history:

Dr. Casebeer is considered the "Father of Refractive Surgery"

In 1999 Dr. Charles Casebeer and Dr. Guy Kezirian submitted a study to the FDA Ophthalmic Devices Panel for approval of the VISX laser for LASIK (it was previously approved only for PRK).  Casebeer introduced himself as the Chairman and founder of CRS Clinical Research, the applicant for the Premarket Approval (PMA).  CRS/Casebeer hired Dr. Kezirian as a consultant for the study.  While the manufacturer's name has been blacked out by the FDA, the timeline suggests that this warning letter was in regards to the VISX study.  The letter states the FDA audit of CRS was in May, 1999, the FDA panel meeting for the approval of the VISX laser for LASIK was in July, 1999, and the letter is dated August, 1999. 

The inspection revealed several deviations from FDA guidelines which seem to suggest that the study was a sham.  CRS was informed that their statement "The sponsors do not assume responsibility for monitoring individual results" did not release them from their responsibility for data monitoring and validation. 

At the bottom of this page are excepts from an article that Dr. Casebeer wrote to his peers about the profitability of refractive surgery, as well as a link to his complete article.  

July 22-23, 1999 FDA Ophthalmic Devices Panel Meeting

http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3528t1.pdf

This document is over 200 pages long, but careful reading exposes the following:

Ron Link (as a representative for the American public) begins speaking to the panel on page 21.  He asks the panel to raise the standard of care by defining what a complication is (including ghosting, starbursts, halos, etc), and better pre-op evaluation and testing including pupil measurement, contrast sensitivity measurement, predisposition to vitreous detachment, and better informed consent relative to each person's unique set of eyes.  He also (page 24) calls for complication tracking.  He tells the panel that when Dr. Casebeer wrote the manual on RK(radial keratotomy), there was no mention of pupil size, even though Drs. Applegate and Holliday had warned of pupil size in previous scientific journals.

When Ron Link spoke, it was during the first 30 minute open public hearing.  Chairman McCulley allowed 3 surgeons to speak before he allowed Ron and Mitch Ferro (also representing the public) to speak... basically allowing Casebeer's cronies to "eat up the clock".  By the time it was Mitch's turn, McCulley told Mitch he only had 2 minutes.

When Mitch Ferro spoke, (page 27), he testified to being visually impaired by LASIK due to having 8mm pupils.  He spoke of starbursts, halos, and ghosts.  He asked the panel to consider expanding the study parameters to include pre- and post-op contrast sensitivity testing, glare testing, and diplopia.  He further asked the panel to limit the laser's approval based not only on refractive error,  but also on pupil size (page 28).  He also called for regulating the advertising of LASIK to include warnings as to the possible risks and complications.

Casebeer and Kerzirian, a CRS consultant, presented the data on the VISX study of LASIK.  The accountability was very poor.  So poor in fact that Casebeer split the study into two groups.  Group 1 (723 eyes) had 90% follow up at 3 months and 76% at 6 months.  Group 2 (553 eyes) had a much worse follow up (accountability) rate, 57.5 percent at 3 months.

Casebeer effectively excluded 43 percent of the data by splitting the groups and reporting only the better group of follow-up for the PMA.

Dr. Ferris (Good Doc #1) on page 71 expresses concern about this "... and I think that is the concern that the bigger that portion is that we are missing if we are looking for balancing a small negative effect or at least trying to allow the patients to know what the degree of negative effect is, when there is a lot of missing data it is very difficult to assess that."  Page 104 "... the only comment I would have is that my concern is that I don't know what the complication rate truly is lurking out there."

Dr. Bullimore speaks about the issue of accountability on page 82: "Overall the accountability is less than 75% at 3 months and less than 63% at 6 months".  Then he makes a startling observation about Casebeer's cronies who used the 30 minute open hearing to try to convince the panel to approve the PMA...  The 3 doctors were investigators for this study.  One of the doctors was in the bad follow-up group that was deleted from the PMA group and another one just barely made the cut.  Dr. Bullimore "I was, also, intrigued to note that of the three physicians who made presentations to the Panel, one of them wasn't included in the PMA cohort and a second actually just made the cut.  So this is a constant source of concern for me..."  He continues "... we don't know anything about the 30-something percent who are not seen at 6 months".  Then Bullimore says something really outstanding "... there is still need for a standardized questionnaire or instrument to be used for the assessment of patient satisfaction following these procedures".  

Dr. Pulido speaks on page 89 about the accountability issue "I have strong concerns regarding accepting the study as a whole because of the data set and if the FDA accepts this kind of study where accountability is only 57 percent..... The doctors should be chided for bad science, and if they enroll patients into a study, they should be ethically bound to follow up on these patients" .   Page 112: "I really would like your help because if I can get over this accountability problem, this accountability hurdle, I would be very happy in accepting and approving this FDA submission."

Dr. Macsai (Good Doc #2) on page 98 reading from the FDA Guidance Document: "The loss to follow-up typically should not exceed 10 percent at one year, and I have a great deal of difficulty with an accountability of 50 to 76 percent at 6 months".

Here is a link to the FDA Guidance Document that they supposedly followed while conducting the study:

http://www.fda.gov/cdrh/ode/2093.html

This document clearly calls for pupil measurement... but CRS did not control for pupil size (or for dry eyes).

Back to the panel meeting:

Page 107 - McCulley "Was pupil size looked at apropos of the public comments"

Dr. Kezirian "Pupil size was not one of the considerations in this protocol".

They gave patients a subjective questionnaire to complete afterwards.  On page 55, Kerzirian states "clearly one of the frontiers in LASIK is to actually try to improve quality of vision... we aren't there yet with that".  What he didn't say was that 26% reported worse halos than before LASIK (see page 121 when Dr. Mascai does her own math to derive at a complication rate for halos).

Dr. Mascai (page 121) ... "I calculated that 26 percent of the patients were complaining of halos on the worst side and 26 percent of visual fluctuations?"  Page 122 "... is it fair to say that 26 percent complained of worsening of halos whether it be mild, moderate or severe?"

Dr. Wang makes a statement about the difference between pre and post op halos on page 129 "I have a question about visual quality.... Specifically regarding halo, we know that clinically the halo experience after LASIK tends to be more visually significant and affecting the quality of vision than halos that occur naturally in patients without ever having surgery.... the pre op halo comes from asphericity of corneal lens combined optics where post-op comes from this artificial excavation of cornea just like volcano on surface of the cornea, but off sharply at 6 millimeters.  Have you attempted to assess the degree of halo because from my clinical experience those halos that occur after LASIK tend to be more significant".

Here's the part where it gets good...

Page 130

Dr. Bullimore, addressing Casebeer "Firstly, do you think pupil size is an important factor in patient satisfaction with this procedure?"

Casebeer: "As a personal matter, I mean do I, personally, think that"?

Bullimore "Does the sponsor believe that pupil size is an important determinant in -- okay"

Casebeer "I want to answer, but it doesn't seem appropriate"

McCully (bailing out Casebeer) No, I think you told us before you did not assess pupil size"

Casebeer "Correct, so we have no opinion".

In 1996, Dr. Casebeer co-authored an authoritative text on laser vision correction and the warnings about pupil size with regard to refractive surgery were clear. The book is called "Lamellar Refractive Surgery."  casebeer.pdf 

On page 80, Dr. Mannis expresses his concern about the halos after LASIK.  "... 20 percent of the patients were subjectively worse in terms of glare... there was clearly 20 percent incidence of some visual dysfunction... perhaps non-acuity parameters should be evaluated over the entire range of refractive error in this procedure".

We always hear how LASIK is so effective??!!  Not according to the data submitted for this PMA.  See page 49.  Only 39% of the eyes over 7 diopter of myopia achieved 20/20 vision!  (on page 79 it says only 35% of the high myopes achieved 20/20). And for eyes less than 7 diopters it was only 59%.

We also hear how LASIK is safe?!?!  Read page 78.  7.1 percent of high myopes had less than 20/40 BSCVA at 6 months after LASIK. 

On page 150, Dr. Van Meter offers an out:  "We can get around this with appropriate informed consent".

A spokesman makes VISX position very clear about the well-being of patients on page 173 "... the investigators are the ones who have a moral, ethical, and medical-legal responsibility to the patients.  We do not, okay?"

But wait, Casebeer tried to shirk his responsibility to the patients in the material he presented to the FDA, which earned him an FDA reprimand.  Casebeer wrote "The sponsors do not assume responsibility for monitoring individual results".  The FDA fires back in the warning letter "Such a statement cannot serve to release a sponsor from their responsibility.  Data validation is part of monitoring and, as noted above, Part 812 gives the sponsor the responsibility for assuring that a clinical study is properly monitored."

Warning letter from the FDA to Dr. Casebeer:   http://www.fda.gov/foi/warning_letters/m2875n.pdf

In voting for approval of the PMA, why did Bullimore cave in?  Page 182 is quite telling.  Dr. Bullimore "... we are dealing with a procedure here which has probably been performed on 100, 200, maybe 300 or more thousand Americans and then performed by many people sitting around this table.  So, it is with that that I am sort of coloring my perspective on this PMA"

When the vote was in nine voted in favor, zero opposed, and two absentions.  Abstaining were Dr. Ferris and Dr. Macsai.

After the vote, page 192, Dr. Pullido stated "I voted yes only after I was able to get some amendment showing that accountability was poor because that was a real problem with the study, and again I don't want to see this kind of study brought forward in the future".

Dr. Macsai " I cannot assess the safety and efficacy has been established due to the lack of accountability.

Dr. Van Meter "I am, also, concerned about informed consent as patients view this with the barrage of advertising that even though it is not under the purview of this agency or this committee, is outside the range of this discussion, but it concerns me, nonetheless.  I hope we don't have a whole lot more patients with accounts like we heard this morning (Ron and Mitch) come forward with LASIK."

Dr. Ferris "... the data that were included in this PMA are not scientifically adequate for approval".

Did Dr. Casebeer have any other motives for getting this approval?  Check out our Conflicts of Interest page!

LASIK:  An Opportunity for the General Ophthalmologist

by Dr. Charles Casebeer

 Excerpts:

"Refractive surgery is one of a very few things that can help the comprehensive ophthalmologist survive an uncertain future."

"So LASIK is what the general ophthalmologist should learn, if he or she wants to benefit from refractive surgery in a significant way."

"... refractive surgery has the potential to become like dental braces for children."

"Refractive surgery will be an important basis of support for the general ophthalmologist."

"There aren't any more opportunities this size coming down the road".

"Refractive surgery can be the bread and butter of ophthalmology. Refractive surgery may yet live up to its early promise and support the rest of the practice -- the way cataract surgery used to".

"Lasik requires no fine motor skills. (The laser and the keratome do all the really fine work.)"

"Too many people believe that only the highly talented and thoroughly experienced can do LASIK."

The complete text of this disgusting article can be viewed at:

                       http://refractiveeyecare.com/0205-casebeer.pdf

Summary of Ophthalmic Devices Panel Meetings