Excerpts from testimony of Morris Waxler PhD
From examination by Mr. Harris, counsel for EBW Laser
(On tracking of retreatment statistics)
MR. HARRIS: Now, you were present; were you not, during the testimony of Dr. **** down in Orlando, Florida?
DR. WAXLER: I was.
MR. HARRIS: And do you recall his testimony that he from timeto time did statistics for Alcon regarding treatment and retreatment rates?
DR. WAXLER: That's correct.
MR. HARRIS: Do you recall his testimony that, that he was not aware that Alcon kept any overall retreatment rates for machines in a given year throughout the United States and that sort of thing? Did you hear that testimony?
DR. WAXLER: That is correct.
MR. HARRIS: And would you expect a man in his position to be familiar with whether or not the company kept statistics?
DR. WAXLER: I would.
MR. HARRIS: And did you hear that same testimony from **** that he was not aware if the company kept statistics of treatment and retreatment rates of all machines from year to year?
DR. WAXLER: Yes, I remember that.
MR. HARRIS: And were you, would you be surprised that the head of technical services in charge of all the maintenance for all the Autonomous machines in the United States would not be aware of any statistics?
DR. WAXLER: I am.
(On importance of retreatment statistics)
MR. HARRIS: If it proves to be true that Alcon doesn't even keep statistics showing the treatment and retreatment rates from year, from year to year for machines in the United States, would that be a problem, sir?
DR. WAXLER: In my view, yes.
MR HARRIS: And why would that be?
DR. WAXLER: ...The reasons being that retreatment rates, as I said earlier are, were, and as far as I'm concerned, were always an issue in LASIK.... there was always concern with the outcome of a second, of a second treatment. And FDA had very little data on outcomes after retreatments, and so therefore, didn't know if outcomes after second retreatments were as safe and effective as first treatment, so therefore, really made an effort to make sure...that... you achieved the correction that you intended to achieve as closely as possible.... So there was a lot of understanding of the need to keep the retreatment rates as low as practically possible and to define those explicitly in clinical trials.
(On approved criteria for retreatment rates)
MR. HARRIS: And can that 10.5 percent retreatment rate that's been referred to here be found directly in the labeling of the machine as is licensed by the FDA?
DR. WAXLER: It is in the labeling.
MR. HARRIS: And would you explain what that means?
DR. WAXLER: It means that... this is a requirement for the company... it sets the baseline for reporting. It sets the baseline for recordkeeping, so that when those values are exceeded, there are requirements. It is the company's responsibility to make sure that, that, to explore what the, why those retreatment rates occurred and to report them and at the very least record them, keep track of them, and to know what other sequela, if any, occurred and the consequence of those retreatments.... For myopia, my experience when we saw lasers that came in to us for approval for evaluation that had retreatment rates much in excess of 10 percent, we were very concerned. Especially if they got up into the low teens. And certainly if they got up much higher than that....for myopia, I know personal firsthand that there were lasers that came in with retreatment rates in those early, the low teens that we said to the company, go back, demonstrate to us that you can have a better, have an algorithm that produces a retreatment rate that is, has a closer fit between the intended versus achieved outcomes.
MR. HARRIS: And based on your knowledge and experience with the FDA, if Alcon had, in fact, reported yearly retreatment rates of ... above 10.5 percent, would that have created an investigation inside of FDA of why that was true?
DR. WAXLER: I can only say what I would have recommended if I had still been there, and it's basically because that's what we had agreed to as a group as the criteria for approval, so they should have been the criteria for remaining on the market.
MR. HARRIS: And what, if anything, about going over a 10.5 percent retreatment rate would indicate a problem?
DR. WAXLER:... The raison d'etre for this laser should [be you] go in and you come out with vision that is closer to being able to see 20/20.... The biggest concern I have frankly is that, I know that there are overcorrections that require retreatment. How many of those, I have no idea. But that, that number of 10.5 represented undercorrections. You have to remember when you look at that section in the labeling, it says "10.5 due to undercorrections." So when you have a higher rate of overall, gross number, the overall average number of 11 or 12 or 15 or 30, you know, maybe it represents only undercorrections, but maybe it represents overcorrections which is a much more serious problem.... to me, that would be a trigger for both the manufacturer and FDA to say, what's going on here? Why do we have a, an overall retreatment rate that exceeds the treatment rate that we expected and was a part of the clinical trial? Is it due to an excessive number of undercorrections? Why? Is it due to an excessive number of overcorrections, that's alarming. Is it due to a lot of off-label use? That's another set of issues. You know, so there are, you -- when you start pulling at that string, there, it raises a lot of concerns.
(On the significance of not tracking retreatment statistics)
MR. HARRIS: Assume with me that Alcon doesn't even keep track of overcorrections and undercorrections by statistic overall in their own market.... as Dr. **** and Mr. **** testified. Assume that's true, they don't even keep statistics of that sort....
DR. WAXLER: If it turns out that Alcon does not keep those records, that would be my view a serious problem because it goes to the heart of knowing what your device is doing on the market. Seems to me that everyone is, knows that overcorrections in particular are a serious problem, very difficult to correct.... If you've got these unplanned outcomes, you should know what the outcomes are so that you can fix whatever needs to be fixed. I have not enough information to know what the problem is, but there's a, again there's a kind of a footprint of the performance that suggests that people weren't keeping track of key items that would indicate there's a problem with the product.
MR. HARRIS: So if you don't keep track of those things in a statistical sort of way, you don't even know to look for those problems, do you, sir?
DR. WAXLER: That is correct.
MR. HARRIS: And... in your opinion, is induced astigmatism something that Alcon was supposed to keep track of?
DR. WAXLER: Yes.
MR. HARRIS: And assume with me that Alcon did not even keep statistics of astigmatism that occurred on its machine. Would that be a problem from a FDA standpoint?
DR. WAXLER: If they did not keep track of it, that would be, I think that would be a problem.
(On Alcon's obligation to follow up complaints)
MR. HARRIS: And if it was so -- assume with me that doctors around the country including Dr. ****, including Dr. **** who was on the phone call made reports of induced astigmatism to Alcon and Alcon didn't even put those reports together in any kind of statistical or intelligible form, would that be a problem from an FDA standpoint?
DR. WAXLER: ...Even though it was in a conference call, those were complaints in my opinion to Alcon, and... if they were not followed up or not tracked, then that's a problem.
MR. HARRIS: I represent to you that Executive Vice president **** who was helping to conduct that call testified in a deposition that he did follow up on several of the, several of the doctors but did not follow up on Dr. **** and another doctor who had a high retreatment rate and said that, said he wouldn't follow up unless the doctor wanted him to.... Is that the, is that the FDA criteria that you don't follow up unless a doctor wants you to?
DR. WAXLER: No.... There are procedures for following up on complaints. And there needs to be a follow-up -- that was a complaint when it came in as a conference call, and there should have been a follow-up. There didn't have to be a second letter or second complaint for those individuals to trigger an official investigation or procedure.
MR. HARRIS: So once, once those doctors on the phone call that's conveyed their complaints to the president of the company, ****, the head of technical services, and the various other people in the phone call, they were obliged in your view to follow up on those complaints?
DR. WAXLER: Correct.
(On the obligation to track unscheduled maintenance)
MR. HARRIS: We were talking earlier about unscheduled maintenance. And you were asked if you're aware of the maintenance, if you had looked at the maintenance records of Dr. **** or indeed any of the other EBW lasers.... Assume with me that it turns out that those maintenance records simply list the maintenance one after another in order and don't say one way or another if they're unscheduled maintenance and don't attempt any breakdown and don't then compile the unscheduled maintenance together in any kind of statistical way? Is that what you had in mind by reporting unscheduled maintenance?
DR. WAXLER: Well, I think it quite clear what FDA means by unscheduled maintenance.... We... [with VISX and Summit] built in a requirement that in their operations manual, that they define a maintenance schedule. I assume that's still the case. I know we did that. And then, that so anything else is unscheduled, and they had to keep track of the unscheduled because that's what's telling you that there's a problem.
MR. HARRIS When you say keep track of it, does that mean designate them as unscheduled maintenance and put them in some category or does it mean just throw them in a box and forget them?
DR. WAXLER: Keeping track of events that are unscheduled maintenances and service calls.
MR. HARRIS And in your opinion, is there, is there some kind of implication of that, that they're supposed to keep statistical track of that to look for similarities, to look for things that are the same.... or can they simply keep it and forget it?
DR. WAXLER: No.... The whole point of the quality system regulations is to establish a management system that keeps track of events, whether they're clinical events, or in this case device events, so that they can see if there's some degradation of the product over time or is there some unusual piece of the equipment that they hadn't anticipated a problem, like in the recalls that they discovered.... I mean, they found out that, I don't know how they found out those, but one way to find out about those kind of things is, you know, you're doing a lot of service calls on this particular subsystem, and you know, wow, that happened here and there, and you know it shouldn't be happening, so you know there's a problem. Otherwise how do you know there's a problem?
MR. HARRIS So if I hear you correctly, keeping track of unscheduled maintenance has an implied duty to also try to make some sense of it? Try to put it together in some intelligible form?
DR. WAXLER: Yes, indeed. I mean, you know, it's not there just to keep the paper industry happy or the electronics industry. I mean, it's there to, as a protective measure, you know, to catch, to catch problems with the device before they injure somebody. Basically. I mean that's the whole point of it. That's why in the first two years they require the company to specifically report annually those unexpected, those unscheduled maintenance reports
(On whether Alcon tracked unscheduled maintenance of its lasers)
MR. HARRIS: Were you present when ****, the head of technical services, testified under oath that he didn't even know what unscheduled maintenance was?
DR. WAXLER: I was.
MR. HARRIS: And did it surprise you that the head of technical services that supervises all the people that do all the maintenance all over the country didn't even know what unscheduled
DR. WAXLER: I was quite stunned actually.
MR. HARRIS: Did that suggest to you that since they didn't know what it is, they were probably not keeping track of it?
DR. WAXLER: I assume the head of service would know what unscheduled maintenance are and know what they're keeping track of. I don't know what else to say. Yeah, I, I was nonplussed.
(On the implications of failure to track unscheduled maintenance)
MR. HARRIS: Assume with me that **** [head of technical services] is right, that they don't know what unscheduled maintenance is and the company is not, in fact, creeping [keeping] track of unscheduled maintenance in any meaningful statistical way. Assume that with me. Does that indicate that this machine is not being tracked properly from the FDA standpoint?
DR. WAXLER: Yes. I mean, it's a basic fundamental of having a good quality product.
MR. HARRIS: And using your experience, your long experience with the FDA and your knowledge of the regulations, does the -- and operating under that same assumption I had in the previous question that Alcon didn't even have any meaningful, statistical way of keeping track of unscheduled maintenance, does that indicate to you that Alcon had problems it doesn't even know it has because it has no real way of finding out about those problems?
DR. WAXLER: If those facts are correct, I'm saddened to say that's correct. I mean, how would you know that you have a problem with your product that's on the market unless you're tracking a, key features of the product, its performance, both mechanically, electrically, and you know that by getting feedback from your service people. You know that by getting feedback from your clinicians. You know... you need to track that information. There's no ifs, ands, and buts about that.
MR. HARRIS: And by tracking information, do you mean to determine if there are trends of common problems in a machine? Do you mean that?
DR. WAXLER: Yes, I do, because it tells you a lot. If you're getting individual occurrences of quite different problems here and there, that's one thing, but if you are, for example, as it appears in what material I've read, there were strength problems with translators.... Then that's kind of notable, you know, so maybe there is a need for recall on the machine because of some sort of problem with quality in making these translators. I don't know the technical details, but it's a clue that you've got a problem. It's sort of a quality control procedure.
(On the detection of adverse trends)
MR. HARRIS: Is the purpose of keeping track of unscheduled maintenance, one of the purposes anyway of keeping track of unscheduled maintenance, in order to define trends, such as you've been talking about, trends of a problem that seems to be there or trends to be there?
DR. WAXLER: Sure.... Of course. That's the only way you would know that there are any commonalities amongst the problems that are occurring, if there are. And so if you don't track them, you don't know about them. But that's not a good practice.... You can't solve a problem you haven't identified, you know, so you need the input information in order to identify the problem.
MR. HARRIS: I heard your phrase, "if you don't track them, you don't know about them." Did I hear your phrase correctly?
DR. WAXLER: That's correct.
MR. HARRIS: Does that mean that problems can effectively hide in, amongst the various clinics throughout the United States without the company being aware of them because they're not tracking them?
DR. WAXLER: Yes, of course. I mean, but it's the company's responsibility to know what their machines are doing. And so it is not good practice not to know. It's not good practice at all. You need to know what your machines are doing.... So it a big deal. It is not for the faint of heart actually. I don't minimize it because it's, it's expensive, and it's, but it's the only way to know whether the machine is, in fact, working as intended and not creating problems.
MR. HARRIS: It sounds as though you're describing a type of covenant between the company and the FDA in order to protect the public. Is that about the size of it?
DR. WAXLER: That's a good way of phrasing it actually. It's an agreement.
(On investigating complaints of decentrations)
MR. HARRIS: ...If I understand you correctly, the way the process works is if a doctor makes a complaint to the company, the company has to evaluate that complaint and determine if it's appropriate to report to the FDA; is that the way the process works?
DR. WAXLER: Yeah, that's correct.
MR. HARRIS: And if the, if the company is not performing the statistical analysis and looking at the trends and keeping a record of whether it be retreatment rates or unscheduled maintenance, doesn't that significantly impair their ability to determine whether they have a problem or not? ... To file a complaint?
DR. WAXLER: You are absolutely correct. I mean again, how can you fix a problem if you don't know the problem exists. And you don't know the problem exists unless you record data of some sort regarding unscheduled visits, scheduled visits, what you found on scheduled visits even, because sometimes you find on scheduled visits things that were unexpected. So the devil is in the details, and all of those are the responsibility of the manufacturer to keep track of. Adverse events. Even if they're not classified as adverse events, if a doc complains about something, I know it [there] was an earlier issue having to do with decentration. Decentration can be due to a variety of things including the doctor not knowing what they're doing, not following instructions properly, and I absolutely agree that that's true. But the fact that there is a decentration needs to be followed up
MR. HARRIS: And if you had a decentration, wouldn't one thing you'd want to look at is whether there had been unscheduled maintenance in the recent past on that particular machine? Would that be one thing you'd want the look at?
DR. WAXLER: Sure.
MR. HARRIS: And might you want to also compare that decentration with other decentration to see if there had been an unscheduled maintenance of a similar sort on that machine, also? Wouldn't that be a logical thing to look at?
DR. WAXLER: Of course, you'd want to see if there's any commonalities amongst the machines.
(On how problems come to light without the manufacturer tracking statistics)
MR. HARRIS: Now, I've discussed with you up to now an instance where I suppose it might be said the company might be negligent in not keeping, not keeping track of statistics.... Let me propose another scenario. Suppose with me that the company's in acting is in bad faith. In other words, they see the problem. They know it's a problem, but they don't report it to the FDA. In other words, they know they got a machine problem. Is there any practical way for that to get picked up until they're caught?
DR. WAXLER: Not really. The only way that gets picked up.... sometimes when there's a whistle blower within the company.... And then things start to unwind....
(On the accuracy and significance of the retreatment rates)
MR. HARRIS: ...Do you recall Dr. **** [of Alcon] saying that he couldn't be quite sure as to how many retreatments there were of that variety that were done on a different machine where the retreatment was done on the Alcon machine where the original treatment was done an another, but that in any event, it was certainly something less than 20 percent of the totally retreatments. Do you recall that testimony?
DR. WAXLER: I recall that, but I'm not sure I recall that it was Dr. **** who said about the 20 percent. I thought it was someone else. But the -- I do recall that someone....
MR. HARRIS: Right. Well, in any event, even if we take away 20 percent of the retreatments, do we still have significant retreatment problems on a number of these machines?
DR. WAXLER: Sure. There were some that, had almost 80 percent retreatment rate which is astonishing to me....
MR. HARRIS: This indicate a serious problem to you given your experience and training?
DR. WAXLER: It's -- again, it's an indicator.... I mean, that's like sending up a flare saying, there's a problem here. I mean, either there's a serious problem with the docs' use of the instructions or it's a serious off-label issue or something. Something warrants some follow-up. And the 80 percent, 50 percent, 40, 30. These are all very high numbers. So you need to look, you need to look behind those overall numbers to look at what I think is referred to as the actual retreatment rate of the patients, but these overall numbers tell you, it's like a big sign saying, come look at me. I've got a problem.
MR. HARRIS: Did you hear the testimony of **** [head of technical services] that he didn't know of any norm for a retreatment rate, that there was no particular norm? Did you hear that testimony?
DR. WAXLER: Yes, I did.
MR. HARRIS: And did you hear his testimony that he didn't know of any retreatment level that was too high?
DR. WAXLER: Yes, I did.
MR. HARRIS: Was there anything in the testimony that you heard from their head of technical services, ****, that led you to believe that anybody at technical services were paying any attention whatsoever to the retreatment rates you've been describing? Anything?
DR. WAXLER: Well, I don't know whether they weren't paying attention to it or whether they were ignoring the retreatment rates.
MR. HARRIS: Is there any basis for that notion in FDA rules that you can have different retreatment rates for the same type of operation in different parts of the United States?
DR. WAXLER: I've never heard of such a thing frankly.
(On the clinical significance of having a second laser treatment)
MR. HARRIS: Now what's the difference if you get as close as possible with the first treatment? Why not do one or two more? What's the difference?
DR. WAXLER: Well, if you have to lift the flap a second time. You have to set up the patient a second time. You have errors when you're doing the surgery the second time. There are all kinds of issues that you have, that the doc has to send to the patient the second time. If there are inaccuracies the first time, they have to be somehow dealt with in the second go-round. So it is a -- it is not a, you know, it's not something you really want to do.
MR. HARRIS: ...A certain amount of retreatments below what the FDA allows certainly doesn't indicate any kind of problem with the doctor or the machine, does it?
DR. WAXLER: No.
MR. HARRIS: But if the retreatment rates go up to levels you're talking about, 40, 50, 60, 80 percent, that does indicate a problem with the machine or the doctor, doesn't it?
DR. WAXLER: Simply said, yes. I can't see how those can be arrived at in any sensible fashion without indicating some problem, some sort of a problem.
(On the implications of a clinic having certain retreatment rates)
MR. HARRIS: And how about **** University which you've mentioned several times. Is that somebody in your experience that you have confidence in?
DR. WAXLER: Oh, they're one of the premiere laser correction centers. They're early pioneers in this business, and they have... many fantastic surgeons there, lots and lots of experience.
MR. HARRIS: And would the fact that they had a 23.3 percent retreatment rate in 2001 be a problem in your view, in your experience?
DR. WAXLER: It indicates a problem until otherwise demonstrated.
MR. HARRIS: And would the fact that they had a 39.6 percent retreatment rate in 2002 likewise indicate a problem?
DR. WAXLER: That does to me.
MR. HARRIS: Would this be something in your view that would compel looking into by the company?
DR. WAXLER: Yes.
(On what constitutes a reportable adverse event)
MR. HARRIS: Now, we've talked about an adverse event as something that might cause death or serious injury. I guess so far as we know, none of these machines ever caused a death, has it, or has it?
DR. WAXLER: No, unless it fell on them, I can't imagine it would.
MR. HARRIS: All right. So what we're really talking about here is what's, what's a serious injury then?... Now, in your mind, would adverse event be the significant loss of sight caused by the machine undercorrecting or over-correcting? Would that be a significant medical event?
DR. WAXLER: An adverse event is either one of those items that is listed as adverse events that are expected by the device or it's an adverse event or it's an event that occurs to the patient that exceeds the expected rate that's listed.... And then there are various reporting requirements depending on whether or not there was a serious injury or whether it was likely if not corrected to produce a serious injury. Those are the ones that are reported, MDR reported.... If you've got some safety outcome that's pretty good, but the effectiveness is way off, then the risk-benefit is not appropriate. So you need to look at both of those. So when, you know, exceeding a retreatment rate of 10.5 or 10.6 in and of itself... is an adverse event, but it doesn't necessarily mean that that patient had a loss of best corrected vision or it doesn't mean that they had some other clinical sequela, so it wouldn't necessarily be MDR reportable.... But when you have a retreatment rate that is 60, 70, 80 percent, you start to worry about, you know, were some of those MDR reportable? I don't know because I, I don't have the full picture. It raises a concern in my mind.
MR. HARRIS: And what about if the astigmatism takes the form of decentered ablation, and it actually causes double vision so that the person is seeing double everywhere they go? Does that describe a reportable event in your mind?
DR. WAXLER: Yes, those are actually interfering with quality of vision and being able to maneuver around the environment, so there, having blurry vision at night especially is a problem.
(On FDA compliance)
MR. HARRIS: I want you to assume with me that Alcon representatives -- in other words, people speaking on behalf and for Alcon -- told Mark McDaniel in the spring of 2003, in other words, after the events you've studied here, that Alcon was in compliance with all FDA regulations regarding the Autonomous LadarVision system, is that an accurate statement from your knowledge of FDA regulations? That you've been describing here today?
DR. WAXLER: No. I think for the reasons I've stated in here, I think that, you know -- obviously, there are judgment calls, but in my opinion, I don't see how that could be.
(On the manufacturer's obligations after approval of a device)
MR. HARRIS: All right. And once the, once the machine is approved by the FDA, can the company just do nothing else? Is it permissible, once they got their, once they got their permission, just do nothing else, just sit back and relax?
DR. WAXLER: Well, I mean, I think the whole structure of the FDA regulations and the law is, in answer to that, is no. The whole quality system, even during the investigational phase, there are requirement for recordkeeping and so forth. So, and that continues. There's a famous, now famous life cycle map of manufacturer's responsibility throughout the life cycle of the product so they're responsible for it from the conception of the device through its death. So when I say they're married... married to FDA, they're married to FDA. And so there are many, there are many, many processes along that tie them to this web of responsibilities.
MR. HARRIS: Can the number of unscheduled maintenances on a given machine indicate a machine problem?
DR. WAXLER: It can, of course.
MR. HARRIS: And is that one reason it's necessary to keep track of the unscheduled maintenance and keep statistical track of them?
DR. WAXLER: Yes, I agree.
(On the difference between lasers which were recalled and those which weren't)
MR. HARRIS: And do you recall **** [head of technical services] being asked about what was the differentiation between machines that apparently had the same software and the same make-up and the same model number where in a series of serial numbers, a few would be recalled, and they'd skip one or two, and then they'd recall a few more. Do you recall a question along those lines?
DR. WAXLER: Yes, I do.
MR. HARRIS: In your opinion, is there any problem in not knowing what the criteria for the recall was?
DR. WAXLER: Well, I was surprised that, you know, given his position, that he didn't know. You know, I mean, it should have been easy. I mean, I don't know how easy, but it was something he should have been able to tell us, I would have thought. I mean, he was the manager of that group. So I was surprised that he didn't know the basis for that. Somebody should know, and I would have thought he would know....
MR. HARRIS: And did you understand him to be in charge of all their maintenance in the United States of these Alcon Autonomous LadarVision systems?
DR. WAXLER: That's correct.
MR. HARRIS: And what, if anything, would be suggested to you if the, if the evidence shows that the machines are identical through the serial numbers as to their software and as to their build and as to any significant aspects, and some are recalled and some are not for equipment they all have, what, if anything, would be suggested by that?
DR. WAXLER: Good question. Well, either it means that there's some feature about the recall that we don't understand that was specific to certain models and not others....
MR. HARRIS: And let me interrupt that long enough to say that ****, head of technical service, doesn't understand, either, true?
DR. WAXLER: Or that some of the ones that should have been recalled weren't? I mean, and I don't know which of those two interpretations is correct because I don't have enough information. Mr. **** didn't provide any, so he didn't seem to know, which was puzzling, but I don't know what to conclude. I have nothing more to really add to
(On potential for FDA action if manufacturer is not tracking retreatments)
MR. HARRIS: And if you were back in your old position at the FDA and it came to your attention that Alcon was not keeping track of treatments and retreatments in a meaningful way, would you order them to do so?
DR. WAXLER: Yeah, they would have to, they would have to provide that detailed information. And in fact, they would, typically what they did -- again, to be fair to Alcon, they would have to do what would they referred to as an accurate retreatment rate. It would have to – analyze those gross retreatment rates and say, the gross retreatment rates were due to such-and-such and such-and-such, and here's how many were due to overcorrections. Here's how many were due to undercorrections. Here's how many were due to this and that and so forth. So they would have to be very detailed analysis before that would go forward....
MR. HARRIS: ...In any event, it suggests investigation by both you and, both the FDA and the company?
DR. WAXLER: (Nodding head up and down.)
MR. HARRIS: Now, suppose if you were back on the FDA in your old position, it came to your attention that Alcon was not keeping track of unscheduled maintenance in any meaningful or statistical way, would you order them to start doing so?
DR. WAXLER: That typically would come to the Office of Compliance.... Within CDRH.... How they become aware of it would be totally complicated.... Somebody would have to tell them from inside the company.
MR. HARRIS: Just assume with me.
DR. WAXLER: But if that happened, then, sure, there would be a question as to, someone would be questioning Alcon about, you know, how many -- and tell you what goes on in that drill is that the agency inspectors come in and they start, oh, you have a problem with unscheduled maintenance records. Let's see what else problems you have. And they start pulling at these matters and it starts to unravel.
MR. HARRIS: And when you say keeping track of unscheduled maintenance, do you merely mean having it written down somewhere or do you mean analyzing it in some meaningful, statistical way?
DR. WAXLER: No, using it to inform management that there is or isn't a problem with the product. That's the whole point of keeping the information, not just to store it.
MR. HARRIS: And does that same principle apply to treatment rates as well as retreatment rates?
DR. WAXLER: Of course.
MR. HARRIS: So the mere fact that you somewhere somehow have treatment rates and retreatment rates or could get them if you wanted them to, does that meet the requirement?
DR. WAXLER: No. You have to have a, in their quality system manual, they should have standard operating procedures for how to handle those, that information and lay out exactly what they do and how they make their decisions related to that information. It's not there just to occupy the record space. Someone... is supposed to meet rather regularly to ascertain, you know, what's going on with the quality of the product in all of its various aspects. So use that as base data to say you're having a problem with this subcomponent or this subsystem or everything is hunky dory or whatever. So that would be a typical routine, ongoing operation of quality, sort of feedback as it were to make sure the product stays in compliance.
From further examination by Mr. Brown, counsel for Alcon Laboratories et al
MR. BROWN: Are the folks at [**** university] who Mr. Harris told you have retreatment rates of X and Y percent showing up on the billing document committing some sort of a malpractice or acting unethically by continuing to use LadarVision on patients in their practice?
DR. WAXLER: I have no idea what they're doing. I don't know if they're continuing.
MR. BROWN: Mr. Harris asked you about [**** university]’s retreatment rates that show up on that billing document. Remember that?
DR. WAXLER: Yeah.
MR. BROWN: And he said something like 23 percent for some given year period. You remember that?
DR. WAXLER: Yeah.
MR. BROWN: And so if [**** university] tracks how many of patients of those they're retreating and they see that it's 23 percent and they continue to use LadarVision on their patients, are they committing malpractice?
DR. WAXLER: Well, I'm not an attorney. So I wouldn't really know, but I don't even know if they are continuing to use it is what my point was.
MR. BROWN: Well, when they were using. Well, let's take it a different way. They at least were using it in 2001 and 2002 because there's numbers on that billing record, correct?
DR. WAXLER: I see your point.
MR. BROWN: You understand that?
DR. WAXLER: Yeah.
MR. BROWN: So in 2001, what Mr. Harris told you was there was percentage higher than 10.5, correct?
DR. WAXLER: Right.
MR. BROWN: So they knew in 2001 they had a percentage higher than 10.5, correct?
DR. WAXLER: I see your point.
MR. BROWN: And then 2002, they continued to use it on their patients, correct?
DR. WAXLER: Uh-huh.
MR. BROWN: Is there anything unethical about that in your view?
DR. WAXLER: Well, it may be problematic, actually. It might be. The fact that they're problematic doesn't mean that Alcon's not --
MR. BROWN: My question is, do you think for every practice in that billing record that appears to show a billing retreatment rate of above 10.5, if those practices know what their rates are and continue to use LadarVision, does that create practice specific problems in your view?
DR. WAXLER: Probably.
MR. BROWN: So they all may be acting unethically?
DR. WAXLER: Yeah.
MR. BROWN: Was that a yes?
DR. WAXLER: Probably, yeah. I mean, good question.
From further examination by Mr. Harris:
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 Alcons. 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.
MR. HARRIS: And isn’t it up to Alcon to inform the doctors if retreatment rates above 10.5 percent should be something they should look for and should be something they should be concerned about. Isn’t it up to Alcon?
DR. WAXLER: I would have thought that Alcon would have... made explicit what the expected retreatment rates are, and that should be based upon the clinical trial that they did which provided the basis....
MR. HARRIS: Would it surprise you to learn that there are no paper documents of any variety supplied to doctors, not their training documents, not letters, not memos, not emails, not of any variety that tell the doctors to look out for retreatment rates above 10.5 percent such as you've described, nothing. Would that surprise you to learn that?
DR. WAXLER: Yeah, I would have thought that... given the emphasis that we had on retreatments, ... that that would be something that there would be at least a mention, there would be some sort of an implication since it's in the labeling, you know, to be alerted to the fact that there was a certain retreatment rate above which is, it's a problem.
MR. HARRIS: Would it surprise you to learn that numerous doctors have been told by representatives of Alcon that retreatment rates are not important?... They're not a significant part of the treatment process?
DR. WAXLER: I would be surprised.
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