September 24, 2008

LASIK Dissidents Launch 'LasikFDA' Web Site

Jim Dickinson
Editor, FDA Webview & FDA Review

A group of LASIK dissidents, led by injured patient Dean Kantis, have launched a Web site called "to expose deceit, corruption, and collusion by the FDA and the LASIK industry. You've read the hype about the 10-minute miracle. Now get the truth." To disown confusion its look-alike name might invite, its home page prominently declares: "This is not the FDA Lasik site. The FDA Lasik site is here," with a live link to CDRH's LASIK page.

Heavily anchored to excerpted transcripts and video of presentations made at FDA's 4/25 Ophthalmic Devices Panel meeting on LASIK post-marketing experience, the site's home page links to a statement by National Research Center for Women and Families president Diana Zuckerman, an epidemiologist saying: "There's very good information on the FDA Web site about the risks, but who reads the FDA Web site?"

The cite contends that at that FDA panel meeting, "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," the site says, before lamenting that "(n)evertheless, 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?"

The site says its creation is an effort counter such impressions, saying the 4/25 panel meeting "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, 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." Posted by Admin at September 24, 2008 03:19 PM