Former branch chief for diagnostic and surgical devices alleges the FDA caved under pressure from ophthalmologists to approve LASIK devices, despite high incidence of complications.
Reprinted with permission from fdaweb.com
On LASIK ‘We Screwed Up’ Says Ex-CDRH Review Leader
09/08/2009

When it first approved laser devices for LASIK indications in 1998, CDRH “screwed up” in not establishing a standard for acceptable adverse events reported from clinical studies, former branch chief for diagnostic and surgical devices Morris Waxler told FDA Webview in a teleconference interview 9/3. Instead, FDA set upper limits in each product’s labeling and reference a voluntary guidance issued two years earlier. Joined in the interview by Life After LASIK founder Dean Andrew Kantis, who is conducting a post-operative on-line study of the procedure’s injuries, Waxler said FDA was under enormous industry pressure when it approved the new indication and its standards for the procedure “were cobbled together.”

Primarily, he said, CDRH totally lacked in-house LASIK expertise at the time and incorrectly judged the significance of adverse events, which input from an advisory panel had said should be less than 1% of all procedures. Actual experience was above 5% in permanent adverse events that the agency listed in the wrong column as so-called “second-tier complications” such as patient-reported persistent pain, blurred images and night-vision difficulties that were not counted as first-tier adverse events (retinal detachment, lost visual acuity, induction of astigmatism, etc.).

CDRH has been under mounting pressure as FDA’s most “dysfunctional” Center, and last month its latest director, Daniel G. Schultz, was moved to resign over its worsening problems, most recently to do with allegations about allegedly improper 510(k) clearances and low employee morale.

“I think we screwed up,” Waxler said of the 1998 approvals. “Nobody’s going to admit that. Basically, I think people made some of those judgments incorrectly. We were getting advice from very renowned ophthalmologists — more renowned than anyone we had in the agency. We dropped the ball with regard to enhancements with in excess of 10% retreatment rates because there was a great deal of pressure from individual doctors who said they had the freedom as a physician to re-treat when they felt it was necessary for the sight of the patient. We waffled on that, we collapsed on that issue. In some of the clinical trials we were very tough on particular companies that came in with high re-treatment rates, and none of that got translated into a requirement for all the manufacturers. So I think we screwed up.

“It’s very difficult to get them to admit there’s been an error. I just think that’s not going to happen until there’s such a crisis that they’re forced to do so.”

CDRH continues to refuse to act against the procedure or to conduct inspections at ambulatory surgical facilities to force the issue on non-reporting of LASIK adverse events under MedWatch and MAUDE, Kantis said. “The agency says, ‘Oh, we have no complaints coming in!’ They won’t listen to us.” Eighteen months ago, he said, CDRH had only 246 LASIK adverse events reported, a number that has risen to over 1,500 after mass media publicity around an advisory committee hearing on the issue in April, 2008.

“The agency doesn’t want to have a fight with the ophthalmologists,” Waxler said. “Why not?” demanded Kantis. “They’d feel weak,” Waxler answered.

Until enough patients have been injured to get together and mount a big lawsuit, Waxler observed, “neither the independent ophthalmologists nor the agency is going to stand up and do anything.”

FDA’s response

In a statement issued 9/8 by FDA’s Press Office, the agency said CDRH’s Ophthalmic Devices Division “never had standards stating that adverse events should be less than 1% for all procedures. In its consideration of LASIK applications, CDRH followed the October 10, 1996 guidance entitled ‘Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers’.” This guidance contains a section on “Definitions of Major Safety Endpoints and Target Values,” which does say as its fifth point, “Adverse events to occur in less than 1.0% of the population.” However, the guidance lists these “definitions” under a caveat: “endpoints and values are only guidance.”

Less than definitively, FDA’s statement added: “Prior to publication of the guidance document, preliminary drafts were discussed extensively at two public meetings of the Ophthalmic Devices Advisory Panel (7/20/1995 and 4/1/1996). Information from these meetings and input from the Eye Care Technology Forum (ECTF) working group, manufacturers, health care professionals, and consumers, was incorporated into FDA’s final guidance. (Oct 10, 1996). After publication, proposed expansions of the guidance were discussed at two additional public meetings of the Ophthalmic Devices Panel (10/21/97 and 10/22/1998). These discussions resulted in a broad consensus regarding the definition and acceptable levels of occurrence of adverse events in IDE clinical trials for refractive surgery laser systems. These were utilized in the subsequent reviews of LASIK pre-market submissions.”

With regard to Waxler’s comment on retreatments, FDA said it “has not approved retreatment for any LASIK device. Furthermore, FDA’s labeling typically contains the following precaution: ‘It is unknown whether LASIK is safe and effective for retreatment with this laser for LASIK, because it is unknown whether LASIK is safe and effective for repeating the LASIK procedure on the same eye.’

“With regard to the adverse event numbers,” FDA’s statement continued, “preliminary search indicates that subsequent to the 4/25/08 Panel, we received reports of 537 events. However, only 97 of them had a date of the event subsequent to the panel meeting. Only 18 of these were received as voluntary reports.”

The FDA statement responded to Kantis’ comment that “The agency… won’t listen to us” by citing the April, 2008 public advisory panel of outside experts that it convened “to listen to patient experiences with LASIK and consider how to improve information for patients and physicians about LASIK. In response to the feedback from the public and LASIK experts, we have been working on several improvements in our communications with the public regarding LASIK-related safety issues. Our accomplishments to date are listed and frequently updated on our web page entitled ‘Latest on FDA’s LASIK Program’.”