Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

07/07/2014

LASIK patient advocate and former FDA LASIK advisory panel patient representative Paula Cofer has sharply criticized an eight-page FDA letter that denied a citizen petition submitted by former CDER branch chief Morris Waxler seeking the market withdrawal of approved LASIK excimer lasers and a public health advisory on their continued use.

Writing to FDA Webview, Cofer says the letter states that “risks associated with each LASIK device are described in the patient labeling” (patient information booklet), yet in 2006 FDA removed from laser approvals the requirement for patients to be given the patient labeling, stating, “[i]t is the responsibility of the practitioner, who is not regulated by the FDA, to provide the patient information booklet to their patients.”

Prior to 2006, Cofer writes, the conditions of approval for LASIK lasers contained the following or similar language, “[p]rospective patients, as soon as they express an interest in LASIK and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet.” However, she says, LASIK patient advocates have repeatedly complained to the agency that LASIK practitioners withheld the booklets ─ “likely because the information contained in them would cause many patients to decline the surgery.”

Cofer says that in addition, FDA denied that it was ‘pressured’ by laser manufacturers to classify post-LASIK glare, halos, dry eyes, and night driving problems as ‘symptoms’ instead of adverse events; however, the agency acknowledged that these problems ‘may occur following LASIK surgery.’ They state that ‘[n]ot all of these visual symptoms are clinically significant enough to warrant classification as an adverse event’ and are often not persistent, according to published literature.

FDA, Cofer writes, “is aware of several LASIK-related suicides due to these types of so-called ‘symptoms,’ and the agency’s own database of medical device-related injuries contains thousands of reports of these very symptoms after LASIK, many of which describe these ‘symptoms’ as life-destroying. The agency states that ‘such visual symptoms are disclosed as potential risks in the patient labeling’ and that the ‘patient labeling for each LASIK device also includes a summary of the data on these visual symptoms observed in the clinical studies submitted in the PMA application.’

Cofer concedes that patient labeling for LASIK devices, “which most patients never see because the agency won’t enforce, discloses that approximately 20% of patients in LASIK clinical trials report halos, glare (starbursts), night driving problems and dryness persisting beyond the endpoint of the trials.

“Furthermore,” she continues, “the agency acknowledges the issue of problems with future cataract surgery raised by Dr. Waxler, but indicates that it has addressed this problem by partnering with the American Academy of Ophthalmology in the development of a patient k-card to record patients’ preoperative eye measurements. Again, the FDA has placed the fox in charge of the hen house. Virtually no LASIK practitioner provides the k-card to patients because doing so would alert patients to long-term consequences of LASIK, which were not disclosed prior to surgery.

Astonishingly, the agency refers to short-term patient satisfaction surveys in disputing points raised by Dr. Waxler in his petition. The scientists and officials at the FDA know full well that use of unvalidated surveys or questionnaires is neither scientific nor a reliable indicator of LASIK safety or efficacy.

“Indeed, the FDA repeatedly takes cover behind the patient labeling in its letter denying Dr. Waxler’s petition while simultaneously refusing to ensure that prospective LASIK patients actually receive the labeling. Dr. Waxler led the team at the FDA that reviewed the original pre-market application for LASIK. He knows what transpired. He was there. This is not simply a case of FDA failure to ensure the safety of a medical device; this is the FDA acting deliberately in the best interest of industry over public health. This is the FDA saying that patients do not have a right to know the hidden risks of LASIK before undergoing this irreversible, unnecessary surgery on their only pair of eyes. Clearly, as long as the current team is in charge at the CDRH and the Division of Ophthalmic Devices, they will continue protecting Big Ophthalmology.”