May 10, 2008
Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Dear Dr. Schultz:
I was initially encouraged to see the FDA take action by convening an advisory panel on April 25, 2008 to conduct a hearing on LASIK post-market issues including the impact on a patients' quality of life (QOL). However, I attended the hearing and found the lack of panel discussion regarding post-LASIK quality of life (QOL) issues to be disappointing. It was stated publicly before the hearing that QOL would be on the panel members' agenda and there were several accounts from open public hearing speakers who had interacted with hundreds of patients with severe depression and suicidal ideation post-LASIK. Yet there was no discussion amongst the panel members regarding post-LASIK QOL issues.
The open public hearing speakers who discussed the potentially severe emotional toll related to post-LASIK visual disturbances and severe dry eyes included a clinical psychologist, a medical doctor, an optometrist, a father whose son took his own life and left a note detailing his emotional struggles due to his sight having been ruined by LASIK, a wife whose husband took his life last month in Tennessee and left a note stating that his post-LASIK visual disturbances and severe dry eyes were the cause, a wife of a patient who discussed two additional LASIK related suicides, and two patient advocates who have formed support groups for post-LASIK complication patients. Most of the emotional toll from LASIK adverse events was caused by night vision disturbances, loss of best correctable vision and severe chronic dry eyes.
While the FDA has announced plans to study QOL issues related to LASIK, I am concerned that the proposed study will be biased. The FDA and National Eye Institute (NEI) have announced an unprecedented partnership with industry. The American Society of Cataract and Refractive Surgeons (ASCRS) and the
I recommend the following actions be taken to protect and inform the public that the FDA is entrusted to protect.
1. Halos, glare, night-driving problems and chronic dry eyes should be reported as adverse events and not symptoms by the FDA. Mary Weick-Brady of the FDA's Center for Devices and Radiological Health stated the following in a National Public Radio (NPR) interview aired on May 1st, 2008; "If it's a decrease in vision, if it's a halo, if it's a starburst, if it's a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision". In addition, at the FDA hearing on April 25th, 2008, Malvina Eydelman, MD, head of the FDA's division of ophthalmic devices, also stated that it was her understanding that halos, glare, and night-driving problems were listed as adverse events. The statements made by the FDA are consistent and logical when describing these complications as adverse events since they can be permanent and life altering. Therefore, I anticipate that the FDA will officially accept that LASIK induced halos, glare, night-driving problems and chronic dry eyes are indeed adverse events.
2. The FDA has partnered with ASCRS LASIK surgeons who have financial conflicts of interest in the procedure. I request that any ASCRS member with financial interests in LASIK device makers be rejected by the FDA. It is imperative that proper FDA monitoring and oversight controls be put in place to avoid LASIK surgeon-biased outcomes. I also feel that Drs. Lindstrom and Schallhorn particularly should be excluded from such studies, as they have publicly expressed their belief that there is no correlation between depression and post-LASIK adverse events such as visual disturbances and severe dry eyes. These statements have been made despite the fact that two post-LASIK suicides have occurred within the last year where patients have left suicide notes stating that they could no longer live with their post-LASIK vision disturbances and severe dry eyes.
3. The FDA should advise prospective LASIK patients that clinical depression can result secondary to LASIK complications including post-LASIK visual disturbances and severe dry eyes. In order to meet this recommendation, clinical depression should be listed as a potential side effect of LASIK in the labeling and on the FDA website.
In the interest of informing the public of the risks of LASIK, I look forward to seeing the FDA adopt the changes recommended at its upcoming meeting.
Sincerely,
Matt Kotsovolos
