April 25, 2008
I am glad to testify on behalf of the National Research Center for Women & Families, a nonprofit organization that is dedicated to using research-based information to improve programs and policies that affect the health and safety of adults and children.
I am trained in epidemiology at Yale Medical School, and that training is usually very helpful when I participate in FDA advisory committee meetings. Since FDA did not make LASIK safety and efficacy data available to the public prior to this meeting, I must rely on published data on LASIK procedures and interviews with patients who have told us about their experiences.
The FDA’s mission is to ensure that medical products are safe and effective. For LASIK, it is essential that we remember that safe alternatives are less expensive and readily available: glasses and contact lenses. The risks have to be examined in that context.
It is clear that patients who have had serious problems from LASIK surgery feel that they were not warned about the risks. There is excellent information on the FDA web site about the risks of LASIK procedures in general, but who reads the FDA web site? This advisory committee should respond to any questions about the FDA web site by reminding the FDA that there are better mechanisms for ensuring informed consent for patients than the FDA web site or product labeling.
There are criticisms that should be made of the FDA web site information on LASIK, especially regarding specific devices. The FDA web site information for patients and professionals is difficult to navigate and the information is not useful to patients. Even the patient booklets are clearly not designed to help patients: they are much too long, the vocabulary is much too sophisticated — using terms such as “visual acuity” and “N=350″ — and the booklets look like a grad school homework assignment. They are clearly not designed to be read – if they were, they would not start with a biology lesson about parts of the eye. To be blunt: the patient booklets are apparently designed to satisfy someone at the FDA who does not care if any patients read or understand the patient booklets.
I want to conclude my remarks by commenting on the questions you will vote on today. There are several possible adverse reactions that you apparently will not be asked to address, but you should be. Most important are eye pain and chronic dry eye. Dry eyes are the most common complication from LASIK, with approximately half the patients having that adverse reaction in the first week after surgery (Hovanesian et al, 2001) and 20% persisting more than 6 months (Shoja & Beharati, 2007). This problem is more likely among women patients and those with higher attempted correction. Eye pain can be caused by dry eyes, or have other causes. Both are debilitating, serious complications and must be included in your questions.
The need for additional surgery is also important to measure and to warn patients about. Research by Alio et al. (2008), published this year in the American Journal of Ophthalmology , reported that 28% of the eyes treated with LASIK needed re-treatment within 10 years because of undercorrection, overcorrection, or regression. The percentage of patients was even higher: 35%. Patients need that information.
The possibility of high suicide rates among patients has been raised, but better research is needed. I contacted the Emory University researchers whose work has been cited but not published, but was unable to obtain information about their research.
Overall, patients do not seem to have informed consent when they have LASIK surgery, and part of the reason is the relatively little long-term data available to share with potential patients. I would like to assume that the health professionals involved wanted to give the best possible informed consent to their patients, but in general health professionals focus on the “consent” part of informed consent, not the “informed” part. Informed consent is a process, not a piece of paper. Potential patients need clear, understandable information in advance of making a decision. Patient booklets should be short, focused on risks and benefits, easy to understand, user-friendly, andrequired. The information in the booklets should be reiterated by the health professionals, not undermined with reassuring statements such as “this procedure is very safe” or “all my patients are very happy.” Patients deserve better and it is your job to urge the FDA to make sure patients get the information they need.
Alio JA et al. Ten-year follow-up of laser in situ keratomileusis for myopia of up to – 10 diopters. Am J of Opthalmology 2008; 145: 46-54.
Hova JA. Symptoms of dry eye and recurrent erosion syndrome after refractive surgery. J Cataract Refract Surg2001; 27: 577-584.
Shoja MR Besharati MR. Tear volume and stability after LASIK. Eur J Ophthalmol 2007; 17 (1): 1-6.