4/25/08 FDA LASIK Hearing: Summing things up...

I'm not done commenting on some of the specific things that took place at the meeting and their significance, but in the meantime I would like to give a brief sum-up of my personal opinion about what each "group" accomplished collectively at Friday's meeting.

THE CONSUMERS

1. Effectively communicated to the Ophthalmic Devices Panel that chronic dry eye and vision distortions both can occur in a degree of severity that should classify them as serious complications with serious quality of life impact, and that this badly needs addressing both in warnings before surgery and in the care of patients after surgery. (Sadly, there is little to nothing the ODP can do about it.)

2. Got enough solid press coverage to raise public awareness of LASIK risks higher than it has been in probably at least seven years (i.e. back when SurgicalEyes was generating a lot of press coverage.) Will it quickly return to the status quo, or grow? Time will tell.

THE DOCTORS / INDUSTRY

1. Got excellent press coverage.

2. Unabashedly used the event as a well-orchestrated marketing opportunity.

3. Did an excellent job of further alienating complications patients. Could not have performed their respective parts with more gusto if they'd planned it that way. I think in this regard they played their cards wrong. Time will tell.

THE OPHTHALMIC DEVICES PANEL

1. Had an excellent chairperson in Dr. Jayne Weiss.

2. Did a good job of listening, and certainly seemed to “get” the key concerns the public was putting across.

3. Recommended to the FDA the inclusion of some important new warnings in their information for patients getting LASIK.

... And is in no position to accomplish much more than they did, because of the limited role of the FDA in LASIK.

THE FDA

I can only say I hope and pray they are willing and able to ensure the instrument they are devising to use in their 1,200 patient study is what it needs to be. There is reason for worry, and some of the worries were raised by the ODP.

THE UNITED STATES NAVY

Remind me, why are they on this list?