Waxler says political and industry pressure had a lot to do with FDA’s willingness essentially to look the other way when it came to the side effects. “The heat from Congress was tremendous, and the agency didn’t want to have a fight with the high-powered ophthalmological group. We tried to accommodate their interests,” he says. “Who got hurt were the patients. Patients don’t have a voice at the agency. Patients are an afterthought.”
LOOK TWICE. When activists urged Lasik patients to report adverse reactions directly, the number of negative outcomes in Food and Drug Administration's database soared.
Dry eye can be severe or disabling in some cases. Dr. Anat Galor, who is a surgeon at Bascom Palmer Eye Institute, says an estimated 20 percent to 30 percent of Lasik patients have painful and itchy (but manageable) dry eye, but 5 percent of patients have severe dry eye. Severe dry eye is permanent and extremely uncomfortable and can require the constant use of eye drops and moisture goggles. Nearly 1 percent of patients, Galor says, are unable to function as a result. Galor and Dr. Perry Rosenthal, who is the founder of Boston EyePain Foundation, say that in extreme cases, dry eye is a neuropathic pain syndrome that’s brought on by Lasik. Both researchers published papers in medical journals in 2015 about this rare but debilitating phenomenon.
Even if rare, the consequences of lost vision and pain can be profound. According to Cofer, seven Lasik patients committed suicide because of disastrous outcomes, at least two others attempted suicide and countless cases of suicidal thoughts have been reported by Lasik patients who had bad outcomes. Activists say the depth of these patients’ suffering merits a better response from FDA and surgeons.
When it comes to the benefits of Lasik, misinformation also is common: If your goal is never to use glasses again, you’ll be disappointed. Activists say doctors rarely are upfront about information—gleaned from the few long-term studies that exist—that shows that Lasik regresses, or wears off, over time. Further, because of the eyes’ natural aging, you still are likely to require reading—if not corrective—glasses as you age.
KEEPING TABS. Careful records of how often that adverse events happen in the real world help to construct a safety profile for a procedure. However, not only is what constitutes an “adverse event” with regard to Lasik being called into question, but surgeons and manufacturers also have been remiss in reporting adverse events. This means that the safety of Lasik likely is inflated.
Take the case of a devastating side effect that’s called post-Lasik ectasia, in which a Lasik-weakened cornea buckles and causes vision that’s so distorted that it renders a patient legally blind. We spoke with the office manager of a leading cornea specialist, two lawyers who specialize in cases that involve Lasik and injured patient activists who tell us that it’s common for patients who suffer from post-Lasik ectasia to be told by their doctor that they instead have keratoconus, which has similar symptoms. Because it’s a naturally occurring disorder, keratoconus wouldn’t have to be reported as an adverse event. However, if a patient had Lasik and shows these symptoms, it really is post-Lasik ectasia, experts tell us, so calling it something else is an attempt to dodge reporting an adverse event.
Lawyer Todd Krouner says he never had a Lasik-related case in which the surgeon reported any adverse event. Available medical literature reports that post-Lasik ectasia occurs in about 0.66 percent of Lasik cases, but, Krouner asks, “How do you know that is true if not even the leaders in the industry are reporting it to the FDA?”
Waxler says that as an expert witness in personal-injury lawsuits, he saw files that were maintained by surgeons of adverse events, including some during clinical trials, that never were reported to FDA. Waxler offered this information to FDA’s Office of Criminal Investigations in his petition but says he never got a response. When we asked FDA about this, the agency, instead of addressing the handling of Waxler’s petition, responded that anyone is free to submit information that’s related to misconduct to the office of compliance.
In 2009, FDA started to crack down on the reporting problem by issuing warning letters to 35 facilities that didn’t have adequate reporting systems in place for adverse events. Around the same time, patient advocates began to push injured patients to report their own negative outcomes.
Our review of FDA’s adverse-event-reporting database revealed 499 reports of adverse events in 2015, through May. In 2014, the database had 1,801 reports. Most reports were filed by patients, not surgical centers or manufacturers. Before 2007, the totals were in the dozens, or low hundreds, according to an analysis that was performed by activists on older data that aren’t available on FDA’s website. Activists’ analysis reveals that, through 2011, 55 percent of the reports were filed by patients.