The testimony of Morris Waxler, former FDA official, sheds some light on why LASIK complications are under-reported. It appears that there is also a disconnect between the industry and the FDA.
MR. HARRIS: And if the doctors were never told by Alcon that 10.5 percent, operating above 10.5 percent retreatment rate was a problem, they might not even know that, true?
DR. WAXLER: That's true. It's really an interesting situation where the, both the panel and Dr. Rosenthal explicitly stated in their panel meeting that the retreatment rate was an important part, and it was required of all manufacturers in response to panel members questions, and it was in the labeling, and it is in the labeling for all the machines, not just Alcon's. And the fact that neither Alcon nor apparently the agency or apparently the docs have emphasized that feature of the requirements doesn't mean it's not a problem. It means that there's been some serious problem in communication about the importance of retreatment and a lack of understanding of, of paying attention to it. And I think the manufacturer, you know, it's their machine. I mean, to be honest with you, I mean, the manufacturer incurs a heavy responsibility, and I feel for them because they really, you know, anybody can use their machine. They sell it to people. They don't -- they can't keep track of their outcomes. It's quite true. They depend on these docs to report to them. But they also -- those docs depend on accurate information from the company about what was expected in terms of, you know, what's an acceptable retreatment rate. And I don't know from firsthand knowledge what, what Alcon communicated to its docs about what is an acceptable retreatment rate.
The Lastest Hype: What About Wavefront Results? There is a 9% dissatisfaction rate.
August 1, 2002
DR. GRIMMETT: Dr. Michael Grimmett. I just had an observation and would like to hear if you have a comment. You may have none. There may be no answer. I found it curious that despite a very comprehensive analysis and sophisticated technology, that the patients that were unsatisfied or extremely unsatisfied approximated 9 percent. It's notable that the PERK study (A study of radial keratotomy patients) by comparison, using bear skins and stone knives, had an 11-percent dissatisfaction rate, and I found it curious that one in 10 patients are unsatisfied, despite a phenomenal amount of technology and analysis, and I would like to commend you on a superb analysis and presentation. Do you have a comment why it's still one in 10 despite all the sophisticated technology or is there no answer to that, sir?
DR. PETTIT: No. Well, I don't know everything.
DR. GRIMMETT: Dr. Bradley stated wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye, and he also wrote there's no way wavefront-guided LASIK can correct higher-order aberrations and render super-normal vision. That's the second statement. Is that not correct?
DR. BRADLEY: Your memory is better than mine, but I can look at the slide.
DR. GRIMMETT: No, I believe I transcribed it correctly.
DR. BULLIMORE: I agree. This is Dr. Bullimore. I agree with the sentiments of both of those statements. Exactly how the second one is worded, we could come back to, but the first one adequately ??
DR. WEISS: Can you repeat the first one again?
DR. GRIMMETT: Sure. Wavefront-guided LASIK does not reduce the level of higher-order aberrations of the preoperative eye.
DR. WEISS: Would that not be confusing to someone? Wouldn't that be confusing?
DR. GRIMMETT: Michael Grimmett. It may suggest somehow wording in that wasn't it that the higher-order aberrations were 20 percent higher than the preop eye in the wavefront-guided versus what, 80 percent was the number?
PARTICIPANT: Seventy-seven percent.
DR. WEISS: In here, is there any place saying that LASIK itself increases aberrations and that customized corneal ablation increases them less than conventional treatment?
DR. GRIMMETT: I think that's the idea.
DR. WEISS: So maybe we could put that wavefront-guided ablation ??
DR. GRIMMETT: Conventional LADARVision LASIK increases higher-order aberrations by that figure 77 percent while wavefront-guided LASIK increases them by whatever, 20 percent, whatever the number is, or you can say reduces them to a 20-percent level, if you want to use the word "reduces."
DR. BULLIMORE: I would avoid the term "reducing."
DR. WEISS: I would say each of them increases it because basically whether or not you're treating the preexistent or what's induced, the bottom line is you still have more aberrations than you did when you started off.
DR. GRIMMETT: Well, the intent is telling the traffic cop that you're speeding less than the other speeders.
In the following testimony, Ralph Rosenthal, M.D., Director, Division of Ophthalmic Devices, states that patients don't do as well in the real world as they do in clinical trials. This meeting was called to review clinical trials of phakic intraocular lenses, another elective eye surgery to correct myopia.
October 3, 2003
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.
DR. McCULLEY: But you don't have data to support that the people who do the trials are the best of the best.
DR. ROSENTHAL: No.
DR. McCULLEY: I think that is opinion ‑‑
DR. MACSAI: That's my opinion.
DR. McCULLEY: That is Marian's opinion, and it should not be in our discussions.
DR. WEISS: So we're going to take out the "god" factor out of the discussion.
(Laughter.)
Editor's note: This device causes a loss of endothelial cells, which are vital for the health of the cornea. These cells do not regenerate. If too many cells are lost, the cornea will become cloudy and a corneal transplant may be required. In the discussion that follows, panel members were concerned about the potential long-term decline of endothelial cell density with this device. Dr. Rosenthal, FDA Division Director, speaks up to protect physicians at the expense of patients' well-being. More from the transcript:
DR. MATHERS: I would agree that it is important to patient care. There are some patients here that had very substantial loss in cell count, and you would want to pick those up. And it would be important for that patient's well‑being that you do so at some not short interval after surgery, perhaps a year or something like that.
DR. WEISS: So if you're going to give guidance as far as when repeat specular microscopy would be done, what would you suggest?
DR. MATHERS: As early as three months, possibly six, and at latest, one year.
DR. WEISS: Somewhere between six months and a year. Dr. Macsai.
DR. MACSAI: That's not what I intended by my comment.
DR. WEISS: What did you intend?
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.
Later in the discussion:
DR. MACSAI: You may not put it in your eye, but it meets the guidance.
July 1999 FDA Ophthalmic Devices Panel meeting: Dr. Rosenthal comments that it is outside the purview of the Agency if a physician fails to provide adequate informed consent to patients. Patients' only recourse is to file a lawsuit against the physician.
DR. ROSENTHAL: We cannot tell them how to write an informed consent. We can tell them what the labeling issues are with respect to the device, the adverse events, the complications, the potential hazards, and we can embolden it in big bright blue letters, but if a doctor does not want to tell it to the patient, we cannot tell him to do so.
DR. MC CULLEY: The check and balance in the system for that physician who does not is our legal system.
DR. ROSENTHAL: I am afraid.
Editor's note: From the same meeting transcript, Dr. James P. McCulley, Chairman of the panel, appears to let Dr. Charles Casebeer off the hook when asked about the importance of pupil size:
DR. BULLIMORE: A couple of very quick questions while he is still at the table. Firstly, do you think pupil size is an important factor in patient satisfaction with this procedure?
DR. CASEBEER: As a personal matter, I mean do I, personally, think that?
DR. MC CULLEY: No, I don't think we want personal --
DR. BULLIMORE: Does the sponsor believe that pupil size is an important determinant in -- okay.
DR. CASEBEER: I want to answer, but it doesn't seem appropriate.
DR. MC CULLEY: No, I think you told us before you did not assess pupil size.
DR. CASEBEER: Correct. So, we have no opinion.
Editor's note: Pupil size measurement was required in the guidance document for clinical trials of lasers for LASIK. So why did the FDA not require the investigators follow the protocol? FDA approved this device based on insufficient information. Subsequently, many patients with large pupils were treated on this technology and suffered permanent visual impairment.