Reprinted with permission from www.fdaweb.com
Former CDRH chief of ophthalmic devices Morris Waxler and leading Houston, TX ophthalmic surgeon Stephen G. Slade came to a televised Mexican stand-off 9/28 on the safety and effectiveness of elective LASIK vision correction. After the seven-minute CNN segment, anti-LASIK activists accused Slade of making false statements in it.
The segment opened with Waxler saying LASIK’s approval was mistaken because his review team focused on making sure there was no loss of visual acuity from the procedure and did not pay enough attention to other problems like post-procedure glare, halos and night driving problems. His examination of post-approval FDA experience reports showed that only 60% of patients were able to get rid of the glasses and contact lenses — this, plus the level of adverse events demonstrated to him that LASIK is “a failure,” Waxler said.
Slade disagreed, calling LASIK “arguably the most-studied elective procedure in the U.S.” with over 16,000 eyes “extensively studied” for the issues cited by Waxler –“The science is there. All branches of the military have approved it, including the astronauts.”
Waxler responded that he “heartily disagreed” with Slade’s comments, though he respected him “a great deal.” He said he had looked at the PMAs and confirmed that patient problems remain after a year, for a failure rate of over 50%, counting failure to be able to discard glasses and contact lenses, 18% reporting glare, halos, and dry eyes. “It took me 2-3 years to figure out I was wrong to discount haze, halo, glare … people have a miserable time with their LASIK.”
The studies cited by Slade, Waxler said, were done by “people who have a financial interest in the outcome. Not one independent study has been done. … some of the military ophthalmologists have a side business in doing this … they have profited mightily. LASIK has been promoted as if it was like having your fingernails manicured or your hair curled. It’s not. You’re taking a perfectly formed cornea, messing it up by making a slice, putting a flap over … you have a lot of problems.”
Slade responded that he disagreed with everything Waxler said. Night vision for driving “is better after LASIK than before LASIK,” Slade contended, adding that “FDA agrees with this.” Some of Waxler’s data come from 20-year-old technology, Slade said, challenging viewers to think what their laptops and cell phones were like 20 years ago. LASIK is no longer performed by “slicing” the cornea but by use of lasers. As for dissatisfied patients, “we will do everything we can for them.” Ectasia (corneal scarring) rates are far lower than Waxler said, and there a now new drugs for dry eye, Slade told CNN.
In on-line reactions to the CNN segment, injured LASIK patient Paula Cofer said it was “a lie” that LASIK surgeons “are very interested in helping patients with LASIK complications. … For one thing, they have NEVER reached out to us, and for another, they know there’s nothing they can do for us. I’ve been to several of the so-called ‘best’ surgeons in the country and even Canada and the UK. They just want us to shut up and go away. Their latest line of defense is saying that all of the problems occurred on the old technology. That’s another lie. I hear from patients almost daily who were injured on the ‘latest’ technology.”
Cofer challenged Slade or one of his colleagues to debate her in an open public forum on the risks vs. “supposed benefits of LASIK. Slade says the science is not there to support Dr. Waxler’s statements. I’ll prove that it is.”
Another patient alleged “industry retaliation” against patients who publicly complain.”We were targeted, stalked and harassed by the LASIK industry and its agents because we spoke out about problems with LASIK publicly,” this person wrote in an e-mail. “The industry, surgeons and their thugs were willing to ruin us to shut us up. This is what happens when individuals speak out against multi-billion dollar industries.”
Injured patient Dean Kantis, operator of the Life After LASIK Web site, told his email network that he had been called by Slade after the CNN segment aired to argue issues Kantis had emailed to him. During the conversation, Kantis wrote, Slade contended “more than once” that the LASIK flap does heal. This is a contentious issue in the LASIK community; Kantis said he told Slade that the post-LASIK flap loses 98% of its strength and as reported in Scientific literature never heals. Slade ended the conversation quickly after that, Kantis said.
Texas patient Sylvia Stephens emailed the network after seeing the segment. “I’ve had 2 procedures on my left eye and 3 on my right eye, all done by Dr. Slade. My left eye is not perfect, but I’m satisfied with it; however, my right eye had very bad double vision after an enhancement. I had the 3rd procedure to try to correct the double vision. The doubling is not as bad now but I cannot see clearly out of that eye at any distance – near or far. It bothers me constantly as it is my dominant eye. I regret having the surgery. And in my opinion, Dr. Slade is one of those doctors who will never admit a mistake or that something may be wrong. He was recommended to me as being ‘the very best.’ I beg to differ.”