Dr. Morris Waxler's presentation to the FDA Joint Advisory Panel on 2/24/2015 regarding Avedro's application for approval of riboflavin/UVA corneal collagen crosslinking:
Joint Advisory Panel members have at least two public health dilemmas.
1. Dilemma A: Polymerizing agents may hide a high rate of LASIK-induced ectasia, induce long-term corneal problems, and/or make permanent other LASIK-induced adverse events and visual aberrations. Panel members are being asked to recommend approval of corneal polymerizing agents without knowing the true rate of LASIK-induced ectasia.
1.1. Questions for Panel members to consider.
1.1.1. Should you recommend approval of a product masking a high rate of LASIK-induced ectasia?
1.1.2. Should you recommend approval of prophylactic polymerizing agents for LASIK-sickened corneas if the true rate of LASIK-induced ectasia is very low (<0.1%) as claimed by the LASIK-industrial medical complex?
1.1.3. Wouldn’t treating a large number of LASIK-sickened corneas with a low probability of LASIK-induced ectasia have minimal benefit and maximize risk by locking in structural defects causing visual aberrations, haze, halo and causing unknown long-term problems?
1.2. Keep in mind why we do not know the true rate of LASIK-induced ectasia.
1.1.1. Refractive surgeons and user facilities (manufacturers) keep secret files of LASIK-induced ectasia.
220.127.116.11. I have personally reviewed some of these secret files.
18.104.22.168. I told FDA about the existence of these secret files months ago.
22.214.171.124. FDA has not asked me for any information about these secret files.
126.96.36.199. FDA appears to have withheld information about the secret files from Panel members.
1.1.2. FDA has been and continues to facilitate an epidemic of LASIK-sickened corneas by
188.8.131.52. False and misleading promotion of LASIK on its website
184.108.40.206.1. Using a figure falsely showing no dry eyes and night driving problems one year after LASIK.
220.127.116.11.2. Failing to document the data base for this false figure while dropping it from its website after Dr. Waxler told FDA it was false.
18.104.22.168.3. Using vague statements about worst case possibilities of LASIK while withholding actual percentages of adverse events (e.g. 20% or 4%) from consumers.
22.214.171.124.4. Using euphemisms for adverse events, e.g. complications or symptoms.
126.96.36.199. FDA’s continuing indifference to the pain and suffering of LASIK-injured patients, e.g. failure by FDA to take action regarding
188.8.131.52.1. Nearly 4,000 MEDWATCH reports.
184.108.40.206.2. False and misleading advertising and promotion.
220.127.116.11.3. Correction and preventive action to minimize LASIK-induced injuries.
2. Dilemma B: What rate of LASIK-induced ectasia is acceptable to Panel members? 20%, 10%, 4%, 1%, or 0.1%? Millions of Americans have and are going to have LASIK. How many legally blind people are acceptable to you for a few years of “20-happy vision”?
Recommend DISAPPROVAL. I urge Panel members to recommend DISAPPROVAL of corneal polymerizing agents until FDA establishes through its control of device manufacturers and user facilities:
1. The true rate of LASIK-induced ectasia.
2. The root causes of LASIK-induced ectasia.
3. Corrective and preventive actions to reduce root causes of LASIK-induced ectasia.
4. Establishment of a medically and ethically acceptable rate of LASIK-induced ectasia.
FDA in collaboration with the refractive surgery industry has created a LASIK-induced epidemic of sick corneas. One long-term sight-threatening adverse event is LASIK-induced ectasia. The true rate of LASIK-induced ectasia will be buried forever if the Panel recommends approval of FDA’s plans to approve products polymerizing sick corneas.
FDA leadership on LASIK products has a long-standing collegial and professional bias towards fellow ophthalmic professionals in the industry. They work out many issues in regular private meetings; I know because I led many of these meetings and know of many others. FDA needs to change this structural prejudice by meeting regularly with LASIK-injured patients. FDA should focus more on public health, and not solely on the needs of industry.
I urge Panel members to send a strong message to FDA. Recommend DISAPPROVAL of corneal polymerizing agents.
Disclaimer: The information contained on this web site is presented for the purpose of warning people about LASIK complications prior to surgery. LASIK patients experiencing problems should seek the advice of a physician.