"They Wanted to Make Money. And (the FDA) Helped Them."

In Featured Article, Health Warning

Getting laser surgery to fix your eyes is the last thing you want to do. We’ve told you plenty of times before about the horror stories that come from it.

You may also remember that we spilled the beans on Lasik eye surgery, when we talked to a former FDA chief about it. And how he told us that the FDA should never have approved it in the first place.

That story fired up at least one Lasik eye surgeon and kicked off a fiery debate between them. (If you didn’t see those articles, you can read both of them here.)

Since then we’ve gotten tons of feedback on this issue, with many of you asking us to look into it further.

So we decided to go back to the source and do another interview with the former FDA chief himself.

His name is ­Dr. Morris Waxler. And in this interview, we dig even deeper into what he knows about the FDA.

“I think the agency is structurally deficient,” he tells us. “And it really can’t do its public health job adequately.”

This comes from a guy who was a leader at the FDA for four years…and still has friends who work there.

He also reveals:

  • The real problem with the FDA approval process…
  • Why he thinks too many crimes have been committed in the case of the laser eye devices…
  • Why he originally approved the devices…
  • How the FDA has responded to his speaking out…

Keep reading below to get our full interview with Dr. Waxler…

NHD: Can you tell us what you did at the FDA?

DR. WAXLER: I was in the Office for Device Evaluation, in the Division of Ophthalmic Devices. Within that division there were branches that covered different kinds of devices – implants, contact lenses. And then there was a division that covered a variety of ophthalmic devices such as Lasik machines and other kinds of capital equipment.

NHD: So you focused on Lasik machines?

DR. WAXLER: Yes I did. I was working there as a reviewer to review Lasik devices. Then I was asked to be the chief of that branch.

NHD: And how long were you chief?

DR. WAXLER: I was chief for four years.

NHD: And it was during that period that the Lasik devices were approved?

DR. WAXLER: Correct.

NHD: When did you retire?

DR. WAXLER: In 2000.

NHD: And when were the devices approved?

DR. WAXLER: The first devices that were approved were the PRKs, where they didn’t take a slice of the cornea without making a flap. And those devices were approved, the first one, probably ’93. Then when I became chief, the devices were approved for Lasik. The first one was probably ’95, ’96, maybe ’97.

It was actually a very complicated process because Lasik requires two pieces of machinery. In addition to the laser, you need a microkeratome, which makes the slice for the flap in the cornea. And that device had already been on the market for other purposes. So when we decided to make the laser companies responsible for Lasik, they said the Lasik device included both of those products. That is the laser that removed the tissue from under the flap, as well as the microkeratome which made the flap. So it was a bit of a complicated process. Because initially the laser companies didn’t want to be responsible for Lasik. All they wanted to be responsible for was removing the tissue. FDA folks above my pay grade decided that they had to be responsible for the entire product.

NHD: When you left the FDA, did you leave on good terms?

DR. WAXLER: Oh, absolutely.

NHD: Do you have any personal reasons for wanting to discredit the agency?

DR. WAXLER: Absolutely not. I still have lots of friends there. I got many awards for my work in that branch, and there were never any personal issues. In fact, the only reason I’m back on this issue is I was asked several years ago (by patients that were injured)…why did I approve this terrible device? I listened to that for a couple of years before I decided to look at it in more detail.

NHD: In your position, what role did you actually play in the approval?

DR. WAXLER: A branch chief is the first line manager of a team of technical experts that review the document. The reviewers would review the document and technical information from the manufacturer. And then they would make their recommendations to me, and I would have a critique of the review. Then I would make my recommendation to the division director.

In this particular instance, my engagement was much more hands on than many branch chiefs because there were lots of illegal lasers that were on the market. I was involved in compliance actions against these various folks who were illegally using and producing these devices. So I did a bit more than most branch chiefs did. And also I was very much involved in making sure the ophthalmologists and the refractive surgeons conducted the proper studies.

NHD: When you were reviewing the information at that time, were you aware of the persistent adverse side effects that the lasers presented?

DR. WAXLER: At that time? Good question. Very good question. Well, I would say “yes” and “no.” I was caught up in my job, which was to get these manufacturers under regulatory control. When I came on the scene, there was a sort of Wild West mentality to refractive surgery. Refractive surgeons felt FDA should move out of their way. This was something that the refractive surgeons knew how to do on patients’ eyes. And they took umbrage with the FDA trying to stick their nose in it. So my task was to make sure that FDA processes worked and that everybody that manufactured these devices be under regulatory control. And from that perspective, I was successful.

I think what I wasn’t completely aware of was the extent to which there were the longer-term consequences for patients’ eyes. Partly because…in retrospect, what I realized is that refractive surgeons whom I admired and had tremendous reputations were basically playing a game with me. They kept information. They minimized certain problems. So I assumed as clinicians they would be honest and straightforward with regards to these problems.

I knew there were these night-driving problems. And I knew there were these halos and glare and loss of contrast sensitivity. There were long discussions about that. But the refractive surgeons, their power…not just their monetary power…but their stature in the world, they have a lot of presence and “authority.” They exuded that sort of authority. And I’m afraid that I succumbed to that – the halo they had over their heads – and ignored the halos they produced in people’s eyes.

So I wouldn’t say I ignored it. I just assumed these were minimal kinds of issues. And so it wasn’t until much later, when I saw that the agency had a graph that showed all of these nighttime problems…and all of these glare and halo problems. When I saw the graph on the FDA’s website that says all of these are gone by six months, I said this is ridiculous…we know they’re not gone by six months. When I was there, they were called adverse events and they persisted for a long time.

So I started to explore. And I found out that that graph was actually produced by the industry. And there’s no data behind that research graph. In fact, I went back and reviewed that data. It shows that 20 percent of the eyes that are treated have these persistent problems for much longer than a year.

And one of the most amazing things to me is that the agency still has that graph on its website. And I’ve talked to them several times about it. I urged them to get rid of that graph or explain what the data is. And they will not even do that. It’s just totally incorrect.

NHD: So you did review the documents prior to approval?

DR. WAXLER: Oh, absolutely.

NHD: And it did show that there would be some side effects. But you’re saying that the industry misrepresented how severe and long-term the effects were?

DR. WAXLER: Correct.

NHD: Now the information you’ve seen has convinced you that the original information was misrepresented. How are you finding all this evidence now?

Dr. Waxler: Two sources basically. The first source is from actual data that’s on FDA’s website that anybody can go to. I went back and analyzed the data that exists for each company, and not just the original ones. Some of the refractive surgeons now say that I’m misrepresenting their data by only looking at the early machines. That’s not correct. If you look at my analysis, I include all Lasik devices that have been approved, even the most recent ones. At least up to the time that I published my petition.

I went back to each of the data tables that are on the FDA’s website that came from the company. And I just went down and re-analyzed that data. I looked at how many halos, what was the percentage of halos, and what time after surgery. It took me months and months of hard work. It was not computer work because I had to go in and analyze them by hand.

And then I also analyzed the published literature, the peer review literature. You’ll see a comparison in my petition of the published literature with these same problems and the literature the manufacturers submitted to the agency. And they’re very close to each other. So I don’t think there’s any doubt that there’s 20 percent, or even more, adverse events.

The problem is…what the refractive surgeons and manufacturers want to say is that these should not be called “adverse events.” But these are problems that persist. And they are adverse events. They’re adverse to seeing well. So it’s a word game that the manufacturers and refractive surgeons are playing because they get paid an enormous amount of money to take a few minutes to cut someone’s eye and so-called reshape it.

NHD: So if you were still working for the FDA, do you feel you would have had the independence to be able to look at it from the point of view that you look at it now?

DR. WAXLER: Absolutely. If I was completely aware of what was going on, I would have recommended disapproval. Maybe it would have removed me, I don’t know. But I can’t speak to that issue. That’s all hypothetical. But I certainly know what I would do. I would not have approved it.

NHD: Do you think that this is an isolated situation? Or is there something inherently wrong with the FDA approval process that leads to such risks to public health?

DR. WAXLER: I’m afraid to say it’s the latter…mostly because Congress over the years has developed an approval structure for devices that puts the agency in a very awkward position. It’s a system that favors the manufacturers. It does not favor the public. It’s not a public health law from the standpoint of really primarily trying to protect the public.

Even if you look deeply into the way the studies are conducted…these studies are conducted to get the best possible results. Not to determine what the realistic outcome will be. Not to determine the real risk benefit. What’s the real risk benefit in this situation? We should’ve been right from the beginning, from a public health point of view.

We should’ve said: What is the risk of getting your eye cut and tissue removed in order to correct your vision to 20/20 when you have alternative and much less risky products on the market? You have glasses, you have contact lenses. There was never any such comparison.

You cannot take off a Lasik. Once you do Lasik, your eye is cut. You cannot remove Lasik. You can’t treat any problems you create. With contact lenses, you can remove the contact lenses. With glasses, if you’re having halo or glare or something, you can remove the glasses…get a better prescription.

So I think the agency is overwhelmed because it doesn’t have the resources, but it’s also structurally deficient. And it really can’t do its public health job adequately.

And recently there was a review of FDA regulations, focused on the pre-market notification process, that essentially came to the same conclusion…

So I think it’s a structural problem. I think what my friends at the agency would say was that they did the best with the information they had. And I agree. I think I did the best that I could at the time, but I wasn’t aware of all the forces and all of the willingness of people to outright lie and also to withhold information and to shape the words so they would be in their best interest…and not in the best interest of the patients. They don’t really have the patient’s interest at heart. They wanted to make money. That was the entire effort. And we, the agency, helped them. Again, my focus was to make sure they were under regulatory control. So I did a really marvelous job of doing that. But I didn’t do a marvelous job of protecting the public health. And that’s just the way it is. And I can’t change that…that was then.

NHD: So you filed a petition to the FDA?

DR. WAXLER: Right.

NHD: And you’re asking them to seize all FDA approved lasers…to remove FDA approval…and issue a public health advisory? And also investigate Lasik crimes?

DR. WAXLER: Correct.

NHD: So you believe that the FDA and the Lasik industry knowingly misled the public and that there’s some sort of criminal activity here?

DR. WAXLER: Of course, I didn’t have access to all of the information that’s needed to make a declarative statement. But I know enough. I know a lot of the details of what happened. And in retrospect, I can say that, yeah, there were crimes that went on. The agency has all that information. The agency has the power to look into it, and that’s what I want the agency to do. But I don’t know if they’re doing it or not, because as far as I can tell, they’re not doing anything.

NHD: When you say that crimes went on, is it the FDA you believe committed the crimes? Or is it the industry, the manufacturers?

DR. WAXLER: I don’t think the agency people committed any crimes, including myself. We were trying to do the best we could. We were misled about a lot of information. We were getting partial information. The information we were given [was for] the best patients only. And so there were a variety of tricks that were played on us collectively that led us to the patient decisions.

There’s one exception, though. The graph that I spoke of. It still sits on FDA’s website. It shows that there are no glare, halo…that these sorts of problems do not exist after six months. That graph came from the industry. There’s no data that’s the basis for that graph. Somebody from the agency put that graph on FDA’s website. So someone, or some individuals in the FDA, is personally responsible for doing that. To my way of reading it, I don’t know what kind of crime it is. I’m not a lawyer. But it’s false. It’s misleading. It’s the very thing the agency should not be doing. They shouldn’t be misleading patients that are going to that website.

NHD: But you believe that the manufacturers have acted criminally?

DR. WAXLER: Absolutely. I can point to several instances where they have just withheld information. They distorted information. They would claim that…they couldn’t get file information from 20 percent, 30 percent, 40 percent of the patients that had surgery. And the agency, we went along with that, saying that these patients were so well off that they didn’t want to come back in. That’s a lousy way to run a clinical trial. They should have 90 percent of patients surveyed. That’s their responsibility, to make sure they follow up with patients. But they didn’t, and we let them get away with that…

I can’t say why exactly we did that, except that I think there was a lot of trust involved. There were many very well-known ophthalmologists involved in this. And trust is something that we had, I had…and that misled us.

QUESTION: So how a big a problem do you think this is, and how big a threat to the public?

DR. WAXLER: You have 20 percent of patients who are going to have persistent eye problems. You’re not cutting a marble. It’s not cutting a piece of plastic. You’re cutting a live piece of tissue that has nerves running through it. So almost all patients that have Lasik have problems with dry eyes. For some people it’s a big problem. For some people, it’s a small problem. So Lasik inherently causes eye problems. It doesn’t make a better eye. It creates a sick cornea.

I say patients, but they’re not really patients. They are people that have normal corneas that are not shaped exactly like everybody else’s corneas. It’s a natural variation in the particular shape of a cornea. So this kind of a fix is no fix at all. It’s actually creating an unnatural cornea, a cornea with lots of bumps and irregularities in it. And sometimes the bumps and the irregularities create halos at night, vision problems at night, loss of contrast sensitivity. And, in addition, a long-term risk is undermining the strength of the cornea and producing a bulging cornea. So I think it’s a very high risk, a totally unnecessary risk.

NHD: What has been the agency’s reaction to your petition?

DR. WAXLER: Pretty much nothing. The only thing I’ve gotten in response was that they haven’t been able to make a decision. They’ve had six months to look at this information, and they can’t make a decision. They can’t even make a decision about this graph that sits on their website that’s totally and completely incorrect…and which I have demonstrated in my petition is totally unsupported by the data the agency has in its own files. And where did that graph come from? It came from industry without any supporting data. So, I mean, if they can’t even pull that graph off the website, it’s really, really puzzling. It doesn’t make any sense at all.

NHD: Why is this so important to you? Why do you want to fix this problem?

DR. WAXLER: Because I finally realize that people are being injured by something I did. And although I don’t blame myself, I want to set it right. I don’t want that to be something I’m remembered for. And I’m thankful, actually, for patients that persisted in challenging me to look back at what had been done. Otherwise, I would have gone along merrily saying, “Well, I did a good job.”

So I do feel passionate about it, and I can’t understand why others can’t see the need to do something differently.

Wishing you good health,

Ian Robinson

Editorial Director, NHD “Health Watch”