Reprinted with permission from FDAWeb Review (www.fdaweb.com)
LASIK Patient Advocacy Network founder Scott A. Tolchin has written President Obama asking for intervention to help order a moratorium on LASIK eye surgery procedures due to an alleged increased rate of adverse events related to the procedure. Tolchin’s letter notes that patient advocates are planning a briefing on Capitol Hill 6/22 to discuss the moratorium request.
The letter acknowledges FDA’s recent interest in LASIK injuries, but it says the “problem is that the FDA alone does not have all of the necessary power to enforce the various aspects of LASIK issues that now threaten the public health and the strength of our economy, as more and more LASIK patients hit the disability roles. Advertising practices are governed by the FTC, doctor malpractice which is rampant is not being handled in a manner that proactively prevents adverse events from occurring, and when they do occur, LASIK patients encounter a ‘White Wall of Silence’ that prevents them from getting any justice, and has led to unprecedented incidences of depression, PTSD, and suicide.”
Additionally, the letter charges that FDA has operated in a corrupt fashion under the previous Bush administration by allowing laser devices to be approved that did not meet FDA guidelines or were cleared under a 510(k) based on a substantially equivalent device that was later recalled.
Here is the full text of Tolchin’s letter:
Dear President Obama,
I am writing to inform you of several issues regarding LASIK eye surgery that need to be addressed at a higher level than the FDA. On Monday, June 22, 2009 a group of LASIK patient advocates will be meeting on Capitol Hill to hold a congressional briefing on LASIK. At that briefing we will be calling for an immediate moratorium on LASIK eye surgery due to the fact that the adverse events are in the 30% range and are only allowed to be 1% or less according to FDA guidelines. This was all put into motion when I sent out 200 letters to congress, and filed a Citizen Petition with the FDA
(Docket # FDA-2009–P-0253-001/CP.)
Acting Commissioner of Food and Drugs, Joshua M. Sharfstein has opened an investigation into LASIK, and I believe that Commissioner Margaret Hamburg will be following up on this matter. The problem is that the FDA alone does not have all of the necessary power to enforce the various aspects of LASIK issues that now threaten the public health and the strength of our economy, as more and more LASIK patients hit the disability rolls. Advertising practices are governed by the FTC, doctor malpractice which is rampant is not being handled in a manner that proactively prevents adverse events from occurring, and when they do occur, LASIK patients encounter a “White Wall of Silence” that prevents them from getting any justice, and has led to unprecedented incidences of depression, PTSD, and suicide. I have documentation to support all of these assertions, most of which are listed in my petition on file with the FDA.
The FDA of the prior administration was rampant with corruption. There have been many instances of laser devices being approved that did not meet FDA guidelines or were approved on a 510(k) clearance based on a prior approved device that was later recalled by the FDA and the 510(k) devices are still on the market posing a dangerous threat to the public.
My group, LASIK Patient Advocacy Network www.LasikPatientAdvocacyNetwork.org is just one many LASIK patient advocacy groups participating in the briefing. The briefing is being sponsored by the National Research Center for Women and Families, and is being held in room HC-6, which was kindly secured with the assistance of Speaker Nancy Pelosi. I hope that you will send a representative from your office to the meeting and will assist us in bringing this matter to the public’s attention, and ensuring that the right steps are taken to protect the public health.
Mr. President, even if a LASIK patient has a perfect outcome from a LASIK procedure, there are several serious effects that they may not be aware of that could result in at best the need for glasses and contacts later in life and at worst the need for corneal transplants, corneal failure, loss of the LASIK flap, cataracts, and blindness. 100% of LASIK patients now have an open wound that was originally believed to heal. The LASIK flap never fully heals and makes the patient susceptible to increased risk of eye infections and diseases, inaccurate intraocular pressure measurements necessary for the detection of Glaucoma, and increased risk of the need for a corneal transplant should the patient lose the corneal flap by a poke or strike to the eye. Again, this is the situation for 100% of LASIK patients.
This procedure is an elective and unnecessary procedure whose risks far outweigh its short term benefits that only 70% of the patients may receive. I urge you to please consider supporting our call for an immediate moratorium on LASIK to protect the public while the FDA works through its investigation, which will surely show incidents of corruption with regard to laser manufacturers, conflicts of interest in LASIK studies that resulted in faulty data serving as the basis for FDA decisions, and a procedure that needs to be made illegal in the United States.
Thank you sincerely for your time to review and consider my request.
God Bless you. You are doing a wonderful job for the country.
Scott A. Tolchin
Founder, LASIK Patient Advocacy Network