ASCRS President Denies Accusations of Former FDA LASIK Chief

Source: Cataract & Refractive Surgery Today

Tuesday, September 21, 2010 | Laser Vision Correction


In a scathing three-page letter to R. Doyle Stulting, MD, PhD, president of the American Society of Cataract and Refractive Surgery (ASCRS), Morris Waxler, PhD, the head of the Food and Drug Administration (FDA) branch responsible for reviewing data on LASIK between 1996 and 2000, accused the ophthalmic organization of blatantly ignoring several of the risks involved in PRK and LASIK procedures.

In the letter dated May 7, 2010, Dr. Waxler, who recently said the FDA’s approval of LASIK devices was a mistake, specifically criticizes a proposed ASCRS phase 2 keratectasia trial, claiming it is unethical and puts patients at risk of post-surgical corneal failure, induces corneal thinning and bulging, and increases the likelihood of other permanent LASIK complications.

“The ASCRS Phase II keratectasia trial proposes doctor-induced (iatrogenic) injury in vulnerable patients in order to study iatrogenic insult, instead of mitigating thinning and bulging of the cornea by not performing LASIK and by determining how to stabilize corneas already damaged by LASIK,” writes Dr. Waxler, who goes on to say he will do everything he can to block the approval of such a study.

In support of his claims, Dr. Waxler cites several clinical reports that, among other statistics, say 15% to 30% of LASIK patients suffer from eye pain, glare, halos, dry eyes, night vision and other problems, and 1% of LASIK patients have keratectasia.

Dr. Waxler also accuses the FDA of being “complicit with LASIK manufacturers, ASCRS, and others in minimizing multiple permanent vision complications.” He asked for Dr. Stulting's cooperation in helping to eliminate unnecessary LASIK through more transparency about the short-term "wow" effects versus the reality of permanent eye injury.

In a response letter dated Sept. 20, 2010, Dr. Stulting broadly denies all of the claims and accusations made by Dr. Waxler, calling his view of LASIK “misinformed, unsupported by evidence, and lacking in balance and perspective.”

“LASIK was first approved by the FDA on your watch, following all the required FDA protocols and guidance documents created to measure safety and effectiveness.  In fact, laser vision correction is one of the most studied elective surgical procedures, with 7,830 patients representing 16,502 eyes in US FDA clinical trials from 1993 to 2005 – not to mention more recent submissions to the FDA and thousands of other patients reported in the published literature.  The FDA review process is more stringent than that of any other country in the world,” he stated.

Addressing Dr. Waxler’s accusation that the ASCRS Phase II keratectasia trial poses a danger to patients, Dr. Stulting called the assertion “plainly wrong,” saying Dr. Waxler does not have access to the protocol he references, making it impossible for him to make a responsible, meaningful comment. “Your negative and accusatory comments are inappropriate, misleading, and without foundation,” he said.

Dr. Stulting also said the statistics Dr. Waxler cited were inflated and inconsistent with existing data. For example, the report that Dr. Waxler’s used to claim that at least 1% of LASIK patients have keratectasia actually gave the rate of 0.66%, and even that is the highest estimate in the literature, Dr. Stulting said. Published estimates of its incidence actually range from 0.0004% to 0.66%, he said.

Dr. Stulting also accused Dr. Waxler of manipulating data by referencing the incidence of keratectasia outside of the United States, and on another occasion referencing the results of LASIK treatments with a laser designed more than 20 years ago that is not commonly used in the United States today.

“In summary, your letter is filled with false statements, incorrect citations of the published literature, references that do not fairly represent the existing literature, mischaracterization of a study protocol you have never seen, incorrect reference to outcomes of PRK as if they were for LASIK, citation of results for a laser designed two decades ago as if were representative of modern lasers, mischaracterization of results from older lasers as “better than most,” reference of a graph that does not exist in the reference you cite, and misrepresentations of the actual performance of modern excimer lasers for the correction of refractive errors,” Dr. Stulting said.



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The letter referenced by this article is available at http://www.lasiknewswire.com/2010/05/former-fda-lasik-chief-calls-clinical-trial-unethical.html

--LasikReport (9/24/2010)