Reprinted with permission from www.fdaweb.com
In his first television interview on the subject, former CDRH branch chief for diagnostic and surgical devices Morris Waxler says that the agency didn’t pay enough attention to negative side effects in some patients. Speaking in an exclusive on ABC’s Good Morning America, Waxler said the staff didn’t know what to do with data showing potential problems.
“I wouldn’t say it was pooh-poohed, so much as it was just shoved aside as the kind of, we don’t know what to do with that data,” he said. “It’s right there in the record. The agencies and the refractive surgeons, people knew these problems occur and there doesn’t seem to be a plan to handle some of the more difficult problems that are created.” Reported adverse effects, including cases in which the problems are permanent, include starbursts, halos, glare double-vision, and night blindness.
Waxler said he feels bad when he hears of patients’ bad experiences. “One of the patients asked me, ‘Don’t you feel bad?’ and I said, ‘I did the best I could with the folks that were all around us,'” he said. “But in hindsight, it wasn’t good enough. It wasn’t good enough.” He says he now believes that FDA erred in not setting tougher standards for LASIK outcomes, but doesn’t think the devices should be pulled from the market. However, he called on FDA to make manufacturers and surgeons be more forthcoming with patients about potential side effects.
FDA told the network that it “considers LASIK to be reasonably safe and effective when used as intended,” and said it disagreed with Waxler’s contention that problems were overlooked at the time the procedure was approved. The agency also said it has been cracking down on false and misleading advertising and will be following up with providers who have inadequate adverse event reporting systems.
Last year, Waxler told FDA Webview that CDRH “screwed up” in not establishing a standard for acceptable adverse events reported from clinical studies (see story). The problem, he said, was that CDRH lacked in-house LASIK expertise and incorrectly judged the significance of adverse events, which an advisory committee had said should be less than 1% of all procedures, but turned out to be higher than 5%.
“We were getting advice from very renowned ophthalmologists, more renowned than anyone we had in the agency,” he said. “We dropped the ball with regard to re-treatments with in excess of 10% re-treatment 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.”