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Shedding light on LASIK's darker side [Medical Marketing and Media](Medical Marketing and Media Via Acquire Media NewsEdge) ENTER "LASIK" into your favorite search engine and you'll open a sunny advertising world of bright-eyed people who've thrown away their glasses forev- er after a quick and easy, painless procedure with a high-tech laser. But listen to an unlikely dissi- dent duo-the FDA branch chief who approved the machines and a Harvard ophthalmology professor who has studied their effects-and you'll glimpse the dark underbelly of regulatory negligence, an alleged LASIK adverse event rate 20 times high- er than FDA accepted when the lasers were approved, and oph- thalmology journals that won't publish a word about it. In July, the ex-FDA branch chief, Morris Waxler, asked FDA to reconsider its June denial of his petition to ban these devices. LASIK (laser in-situ ker- atomileusis) is a wildly popular in-office procedure in which a U-shaped flap is cut in the sur- face of the cornea over the iris, the underlying tissue shaved with an excimer laser, and the flap folded back in place. The flap never heals, and is always prone to dislodgement and infec- tion in sporting activities and accidental trauma, critics say. Waxler, who led the review team that approved the first of these lasers for LASIK in the 1990s, was content with the deci- sion until 2004, when a Florida microjet salesman, Dean Kantis, found Waxler in retirement. Kantis belonged to a large net- work of injured LASIK patients. There had been no patient- informed consent in any of their procedures, he claimed; an FDA- required, product-specific patient information brochure was not being routinely given to LASIK surgery candidates. Kantis connected Waxler to other injured patients. At first Waxler was wary, but he became intrigued. "It took me two years to realize something was going on," he remembers. He began a five-year jour- ney of rediscovery, interview- ing severely injured LASIK patients and re-analyzing indus- try data on which he had relied to approve the devices. He peti- tioned FDA to ban them in 2011. Waxler's conclusion: the laser makers had submitted fraudu- lent data to FDA attesting to a less-than-one-percent incidence of post-operative adverse events, whereas his re-analysis showed an incidence of more than 20%. Meanwhile, Harvard Medical School assistant clinical profes- sor of ophthalmology Perry Rosenthal had come to a parallel conclusion about LASIK adverse events. He had identified and studied 21 patients who devel- oped "unrelenting agonizing" eye pain after LASIK surgery, pain that had persisted for 2-15 years at the time of the study. The pain was so devastating and resistant to treatments that most of these patients admitted to thoughts of suicide. Rosenthal also discovered that the onset of this "neuropathic" eye pain was often delayed for years after the patients' eyes had healed. This type of pain had not been reported in the medical lit- erature and because these eyes typically looked normal, the suf- ferers had been accused of exag- gerating or fabricating their pain. Nevertheless, his paper on these findings was rejected by two peer-reviewed ophthalmol- ogy journals, and Rosenthal says he had to post it on his nonprofit website to avoid it being buried. He estimates there are 800,000 LASIK procedures every year worldwide and the pool of sur- gical candidates is growing by 2 million eyes per year. Rosenthal's next step was to send his paper to FDA, despite being warned that the agency would not respond. FDA not only blew off Rosenthal's study, it also blew off Waxler's petition. FDA told Waxler that his alle- gations that laser manufactur- ers had withheld and distorted safety data in their marketing applications and had pressured FDA to classify post-LASIK surgery glare, halos, dry eye and night driving difficulties as "symptoms" instead of "adverse events" lacked sufficient support. On July 22, Waxler filed a peti- tion for reconsideration in which he charged that FDA "grossly underestimates the risks of LASIK by conflating data used to legally support the [marketing approvals] with LASIK indus- try information used to promote sales." In doing so, he wrote, FDA had sent two messages: that the LASIK industry could feel secure because "the agency has your back," and that the pub- lic should beware because "FDA does not have your back." Waxler told the agency that it had "made deals" with the LASIK industry that "degraded the scientific quality of the col- lection and analysis of adverse event data of LASIK devices." He listed alleged deals with Kremer Laser, American Society for Cataract and Refractive Sur- gery, CRS Inc., and more than 100 user facilities that he says received IDEs "to study LASIK in order to minimize their expo- sure to violating off-label rules." Waxler is sanguine about his chance of changing minds at FDA: "The industry owns them," he says. -James G. Dickinson A former FDA branch chief says that the agency should ban LASIK eye-surgery devices (c) 2014 Haymarket Media, Inc. |