11/23/2010

An article titled “Is the Assault on LASIK Justified?” appears in the November, 2010 issue of Cataract & Refractive Surgery Today.

This article is essentially an “assault” on Morris Waxler, PhD, former head of the FDA branch responsible for reviewing the original LASIK clinical trials. In typical LASIK industry fashion, the article’s contributors attempt to discredit Waxler professionally because he exposed LASIK risks. But it doesn’t stop there. The article is also a personal attack, filled with insults and false accusations against Waxler.

Waxler went public in 2009 regarding his concerns about LASIK eye surgery after taking a second look at data from LASIK clinical trials, and also examining recent data published in peer-reviewed medical journals. Waxler communicated with a number of injured LASIK patients in an effort to understand their complaints, and he found a disconnect between LASIK surgeons’ definition of a success and patients’ experiences. Waxler now feels that problems such as persistent dry eyes, starbursts (“glare”), halos, and night driving problems, which may have a profound negative impact on patients’ quality of life, should have been counted as “adverse events” rather than dismissed as mere “symptoms” by the FDA. Importantly, Waxler found that incidence of these problems reported by patients in clinical trials is unacceptably high, even with the latest LASIK technology.

Furthermore, Waxler has serious concerns about late onset complications and long-term risks, which were not detected in clinical trials with short-term follow-up. Specifically, the FDA did not consider delayed post-LASIK corneal ectasia and problems related to the fact that the corneal flap heals only minimally, leaving the cornea fragile and weak for the patient’s entire lifetime. Waxler now believes the FDA made a mistake in approving LASIK devices in an environment of enormous pressure from prominent ophthalmologists who worked hand-in-glove with FDA reviewers.

Injured LASIK patients believe that there has been industry-wide cover-up of LASIK problems from the beginning, and that financially-motivated investigators corrupted LASIK clinical trials by submitting massaged and falsified data and withholding negative data. They also believe that LASIK surgeons will stop at nothing to protect their cash cow.

The LASIK industry and its representatives have a long history of attacking groups and individuals who speak out about hidden risks and long-term consequences of LASIK. Many vocal critics of LASIK have become victims of cyber-bullying, intimidation, threats directed at themselves and their family members, harassment, defamation, interference with employment, frivolous lawsuits, SLAPP lawsuits, and even criminal acts.

Public outcry of widespread problems with LASIK, such as intractable dry eye and night vision problems, led to a showdown between injured LASIK patients and LASIK industry representatives at an FDA hearing in April, 2008. Several cases of LASIK-related suicide and suicidal depression were discussed during the open public hearing. Just weeks prior to the FDA hearing, a North Carolina newspaper reported, “Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery. Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had LASIK as among cornea donors who had not.” Richard Lindstrom, MD, then-president of the American Society of Cataract and Refractive Surgery (ASCRS), a professional organization of LASIK surgeons, was quick to criticize the newspaper in a letter to the editor, characterizing the story as irresponsible reporting and a “disservice to the millions of Americans who elect to undergo vision correction surgery each year.”

At the same FDA hearing, Diana Zuckerman, PhD, of the National Research Center for Women & Families reported that she had contacted Emory in an unsuccessful attempt to obtain more information about the organ donor study, which has not been published. Injured LASIK patients believe LASIK surgeons suppressed the data.

Several months later at the 2009 ASCRS annual meeting, LASIK surgeons performed comedy skits mocking injured and suicidal LASIK patients.

In a surprising turn of events, the FDA began inspecting LASIK clinics and issued warning letters in 2009 for failure to report LASIK complications as required by federal law. LASIK critics say this move was long overdue, as they have complained to the FDA for years that the LASIK industry was hiding LASIK problems.

LASIK critics have nothing to gain by speaking up, and they face backlash and retaliation by the LASIK industry. On the other hand, LASIK surgeons have plenty to lose financially if the public learns the truth about this risky, unnecessary surgery.

LASIK surgeons are crying foul over what they perceive as an “assault on LASIK”. Perhaps LASIK surgeons are concerned about loss of income and potential class action lawsuits which may result from closer scrutiny of the LASIK procedure.