On 10/19/2010, the FDA issued a press release to update the public on the LASIK Quality of Life Study, which has been on hold for nearly three years.
After years of public outcry of widespread, long-term problems with the LASIK procedure and reports of LASIK-related depression and suicide, the FDA announced in 2008 that it would reevaluate LASIK safety. The FDA reported that it had partnered with organized ophthalmology — American Society of Cataract and Refractive Surgery (ASCRS) and American Academy of Ophthalmology (AAO) — to conduct a post-LASIK quality of life study. LASIK patient advocates were extremely critical of organized ophthalmology’s involvement in this proposed study, comparing it to “foxes in charge of the hen house”.
In response to negative press surrounding an FDA hearing on LASIK safety, organized ophthalmology launched a media campaign defending the procedure. LASIK surgeons, supported by ASCRS, published a literature review1 of reported ‘LASIK satisfaction’, but withheld the associated high complication rates from the publication.
About the same time, LASIK patient advocates learned that prominent ophthalmologists who attended an ASCRS convention had performed ‘comedy’ skits mocking damaged and suicidal LASIK patients. FDA blogger, Jim Dickinson, sent an email to ASCRS’ Director of Communications, John Ciccone, requesting confirmation that the skits were presented at ASCRS’ annual meeting. Ciccone confirmed that the skits were, in fact, presented at the meeting; however, he expressed regret over the matter.
Months went by with no word from the FDA on the proposed study. LASIK patient advocates accused the FDA of stalling while hundreds of reports of LASIK-related adverse events poured in to the agency. Apparently, the FDA had quietly scrapped plans for involving organized ophthalmology in the proposed study.
Meanwhile, former FDA chief of ophthalmic devices, Morris Waxler, PhD, came forward to speak out publicly against LASIK eye surgery. In the 1990’s, Waxler had been in charge of reviewing the original LASIK clinical trials, and played a key role in its approval. Waxler now believes that the agency was wrong to approve LASIK devices. He says that the FDA lacked in-house expertise to assess the significance of long-term adverse effects, such as dry eyes and night vision problems. These problems were reported by a large number of patients after LASIK. In hindsight, Waxler feels these issues should have been taken more seriously. Waxler says that very renowned ophthalmologists pressured the agency to approve LASIK. Since the original approval, other very serious, delayed complications have emerged such as corneal ectasia, which often requires corneal transplant.
In October 2009, the FDA issued a second press release announcing plans for a LASIK Quality of Life Project and simultaneously announced the issuance of warning letters to a number of LASIK facilities for failure to report LASIK adverse events. This time, the proposed study was to be a collaboration with the U.S. Department of Defense involving an active duty population treated at the Naval Medical Center San Diego (NMCSD).
LASIK patient advocates expressed strong concern of bias on the part of military LASIK surgeons, particularly Navy LASIK surgeons, who have close ties with organized ophthalmology. For example, Steve Schallhorn, MD, Capt, US Navy (Retired) is a paid medical malpractice defense expert witness and an industry consultant, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, has financial interests in companies that manufacture LASIK devices, and is currently medical director of one of the largest corporate providers of LASIK in the world. An article in the December, 2009 edition of JAMA2 reported that Schallhorn is “confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective”. Furthermore, LASIK patient advocates have questioned a defense contract awarded around the time of Schallhorn’s retirement from the Navy. In December 2006, IntraLase announced that the Dept. of Defense had awarded the company a $45 million, 5-year contract to supply its flap-cutting lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies. Shortly thereafter, it was reported that Schallhorn was a consultant for and had financial interests in Advanced Medical Optics, the company that acquired IntraLase.
Another Navy LASIK surgeon, Capt. David Tanzer, MD, is a member of AAO and ASCRS, and co-authored several papers favorable to LASIK with Schallhorn. Tanzer is the current Director of Refractive Surgery at Naval Medical Center San Diego, and has a private practice at one of the country’s largest LASIK chains, TLC Laser Eye Centers.
In spite of mounting criticisms of FDA’s decision to collaborate with the Department of Defense in a study of post-LASIK quality of life, the agency has now placed Bradley S. Cunningham, formerly of Walter Reed Army Institute of Research, over the division that regulates LASIK lasers. LASIK patient advocates feel that by replacing ASCRS with the Department of Defense, FDA has simply traded one embarrassing collaborator with conflicts of interest for another.
The 10/19/2010 FDA press release states that the clinical study will begin within the next three months at Naval Medical Center San Diego. However, the protocol has not been disclosed. On 9/27/2010, Jim Dickinson requested more information under the Freedom of Information Act, but the agency has been unresponsive so far.
In the meantime, LASIK patient advocates continue to wait, hoping for some action on the part of the FDA to quell the growing number of patients injured by a lucrative surgery that serves no medical need. Unfortunately, it appears that the only thing slowing LASIK down is the economy.
1. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.
2. Mike Mitka. FDA Focuses on Quality-of-Life Issues for Patients Following LASIK Surgery. JAMA. 2009;302(22):2420-2422.