April 25th, 2008 was a historic day for the Food and Drug Administration. On that day, a number of medical doctors, optometrists, psychologists, and injured patients presented at a Special Hearing of the Ophthalmic Devices Panel, responsible for the approval of medical devices for ophthalmic use in the United States. The subject of the hearing was post-LASIK quality of life, depression, and suicide.

Insiders acquainted with the FDA approval process for medical devices were horrified as one by one, the presenters alleged deception by individual LASIK surgeons, cover ups perpetrated by medical device manufacturers, and corruption at the level of the FDA itself. Compelling cases were made for massive violations of federal law, the failure of the FDA to monitor surgical facilities for LASIK, and deliberate misclassification of severe complications as simple side-effects, as a means of securing premature FDA approval of the excimer laser.

The mass media attended and filmed the April 25th hearing. Nevertheless, the substance of the above allegations went mostly unreported, despite the presentation of four completed post-LASIK suicides, including excerpts from two actual suicide notes (these presentations are included in the videos at right). The American Society of Cataract and Refractive Surgeons (ASCRS) asserted that individuals with psychological issues post-LASIK certainly had psychological issues all along. To anyone without a preconceived bias, the ASCRS position seemed indefensible. Still, the mass media focused on a 95% percent satisfaction rate, a statistic put forward by ASCRS, but not yet published in their own peer-reviewed literature. Why?

Fortunately, the entire event was captured on video. Moreover, FDA transcripts are considered government documents, and as such, are not subject to copyright laws. Beyond the obviously sad assocation between severe LASIK complications, depression, suicide, and medical deception and corruption, the April 25th Special Hearing of the Ophthalmic Devices Panel must be regarded as one of the most interesting sociological dramas in modern medicine, one which is still being played out. This site chronicles the events leading up the meeting, including press releases by the American Society of Cataract and Refractive Surgeons (see here and here), videos by presenters on both sides, and the reaction of the American press.

Judge for yourself the significance of these events, and come to your own conclusions about LASIK, the industry behind it, and the FDA.

Dr. Jane Weiss chaired the Ophthalmic Devices Panel meeting in Gaithersburg, Maryland on April 28th, 2008. Press releases issued by ASCRS before the hearing stated that the "FDA confirms that LASIK is safe and effective." Yet, Weiss clearly opts for glasses. Perhaps it's good enough for the public, but it's not good enough for Dr. Jane Weiss.

Reports of LASIK complications to the FDA's MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).

Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events. In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.

The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that "Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients." Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK's approval.

The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that "The FDA reaffirms that LASIK is both safe and effective." LASIK critics have responded to this assertion by asking publicly "When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?"

Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA's website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.

Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that "The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR...does not provide timely and usable data to staff or other system users...[and]...has a large backlog of reports which hampers the ability to detect signals or identify problems." Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?

Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA's intention to call a Special Hearing for LASIK post-market issues. In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?

Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.