Ex-FDA Official Admits FDA "Screwed Up" In Approving LASIK

[LASIK Reporter]

http://www.lasiknewswire.com/2009/09/fo ... lasik.html

Reprinted with permission from http://www.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."

[Cookie]

Wow. For the FDA to admit they screwed up, it really has to be horiffic.

I am still waiting for that announcement re: quinolone antibiotics, but I will let people google "quinolone toxicity" if they wish rather than derail this forum.

Good work, Lasik Reporter.

[Cookie]

Saw this just now and thought of this forum.

FDA to study reports of ill effects from LASIK.

Now if they would only stop minimising reports of ill effects in a lot of other things, including quinolone antibiotics, which can also cause vision problems and eye dryness among countless other adverse effects.

[lasiksecrets]

Don't blame the FDA check this website.
http://lasik-secrets.com/FDA's%20role.html