FDA meeting with patients advocating LASIK ban

Those of you who have dry eye from LASIK may be interested to learn about a patient group meeting with representatives from the FDA on Thursday, September 13.

NEWS RELEASE - Sept 7, 2018 FDA Meets with Patients Advocating LASIK Ban

Mark your calendar for a news conference with a group advocating a ban on LASIK eye surgery. The news conference will take place on September 13, 2018 from 1:00 to 2:00 PM, in the Maple Room at the Sheraton Hotel, 8777 Georgia Ave., Silver Spring, Md. Prior to the news conference, the group will meet with FDA officials at the FDA’s White Oak facility in Silver Spring, Md….

“This is the first time the FDA has agreed to meet with us,” said Paula Cofer of Tampa, Fla., who founded the 6,100-member LASIK Complications Facebook Group in 2014 to give voice to people who have been harmed, she said, by corneal refractive surgeries. “Our membership grows daily because doctors convince patients these are safe surgeries. In fact, they can cause intractable, severe pain; corneal ectasia [deformity], chronic dry eyes, night vision problems and vision loss.”

In a recent blog post, I highlighted some information from TFOS DEWS II’s Pain and Sensation report about how LASIK eye pain patients have been instrumental in drawing attention to the problem of pain in ophthalmology, where traditionally it had been largely ignored. I imagine that the allusion in their report was simply to the collective impact of individual patients’ interactions with their individual doctors.

But for nearly twenty years there has also been a small but determined band of patients advocating for change at a regulatory level. And it seems they are finally getting their day to meet with the FDA.

All things considered, it is astonishing that it could take this long just to even start a dialogue. Consider:

• Peer-reviewed medical literature readily support concerns over the very high rates of dry eye as an extremely common as well as potentially permanent side effect of LASIK. Example here.

• According to this patient group, about 14,000 complaints have been filed with the FDA’s online Medwatch database. This is of course grossly understated, as most people have no idea that complications and side effects ought to be reported, and I wouldn’t hesitate to assert that most ophthalmologists would never consider reporting dry eye as a complication. I don’t believe the question of how many complications and adverse effects get reported has ever been studied.

• FDA involvement over the years in addressing concerns about the need to highlight risks when advertising/promoting LASIK has been scant at best. After gaps of many years. they might issue a little letter to the AAO like this one in which they “recommend” that advertising and promotional materials include information about risks.

The platform being advocated by the group is emotionally worded and extreme in nature:

[Aside: Based on a comment on this article, perhaps clarification is in order: (1) By describing the platform as ‘emotionally worded’, I meant specifically inclusion of phrases like “quit deceiving” and “lives are destroyed”; in no way do I intend to minimize the realities of patient outcomes; and (2) By describing the platform as “extreme in nature”, this is not a personal opinion of the appropriate regulatory steps to be taken in the circumstances but a reflection on how the platform being presented would be viewed by the industry, medical profession and FDA.]

1. Within 30 days, the FDA and doctors must quit deceiving potential patients with promises of zero side effects and, instead, warn the public about the true severity and prevalence of side effects, which is about 20 percent.

2. Within six months, the FDA must convene a panel on care and compensation of LASIK-injured patients, many of whom have lost their jobs and can no longer pay their medical bills.

3. Within six months, the FDA must ban these surgeries, before any more lives are destroyed.

And the bottom line they want to communicate is that “LASIK is inherently harmful….”

My personal perspective?

I could, and perhaps one day will, write a book about what’s wrong with the LASIK industry and about why, given the nature and extent of some of the harm that has been caused, it has not proven practical to hold the industry to account.

But to boil it down to a very compact summary in the meantime, my personal views are roughly as follows:

1. Due to a complex combination of factors, certain LASIK complications and side effects often cause us patients profound emotional harm, which in turn impair our perspectives in some degree at every stage of our journey - in crisis, in recovery, in stability and in advocacy. [Clarification: Since I have clearly offended some people with this, I will add that (1) as I have stated, this is my personal view; and it is based on observations from many years working with patients harmed by a wide variety of elective as well as medically necessary surgeries, which has given opportunities to compare; and (2) I could have been much clearer if I’d added “can in some degree” before “impair”. In suggesting that we incur emotional harm, I absolutely do not minimize or mischaracterize the reality of the complications and side effects but rather intend to add emphasis to how far reaching the nature of the harm done us is.]

2. Ample clinical data exist which would support a reasoned approach to the FDA and/or the AAO highlighting patients’ concerns about the reality of preventable and potentially untreatable harm being done to a minority of patients, that merits attention, and ought to be taken seriously if presented dispassionately and restricted solely to scientific evidence.

3. The American LASIK industry has consistently displayed a gross and determined lack of compassion for those of us who have suffered complications and side effects. Their sole objective when concerns are raised - whether through the press or through regulatory channels - has been to aggressively fight back with claims about subjective patient satisfaction rates (which no one disputes) as opposed to scientific data about ocular surface health outcomes and vision quality outcomes. No concessions, no conciliatory words, no compassion, and no resources are ever extended by industry representatives to those who have been harmed.

The whole thing really is a crying shame.