Reposted with permission


On the subject of LASIK complications, and who knew what and when...let's just say I can't wait for some depositions to go public.


Here's something that is public that may interest you. Hopefully you have read it. If you have, you would know that there was a BIT of a clinical trials problem, with VISX being much more, shall we say 'problematic' than Alcon. Now there's an understatement.


Now why do you think a company would collect contrast sensitivity data and not report same? Hint, LASIK causes loss of contrast sensitivity in all

patients. Don't want to have to actually tell the victims, er... I mean 'patients' about that, so suppress THOSE DATA!!!


Hard to believe that less than 25% of LASIK patients in a clinical study would bother to show up for their follow-up appointments! It is in their medical best interests to be followed for a year. What do you think that huge patient population gone missing has in common? What do you think the patients who were included had in common? Why do you think they lied about 12 month accountability? If you were to derive means of several metrics of outcome measure, do you think the differences between these groups would be statistically significant?


How about patients who report being dropped from clinical trials for having bad outcomes?


Why the reliance on subjective survey data of symptoms when the technology to gather objective clinical data was available? And then to present inferior subjective survey data on only a subset of patients... in a format that any Stats 101 dropout drooling idiot can easily recognize as bad science! Who set up these 'studies', who was monitoring these clinical trials, who was involved in these clinical trials, and who voted to approve these devices?


If your choices in a subjective survey are on a 'better' or 'worse' scale with no actual measure of magnitude, then a patient who sees starbursts that are a bit larger after surgery is scored the same way as the patient who is incapacitated by starbursts from headlights that are larger than the cars that generate them. How much sense does this make?

Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA



 J Refract Surg. 2004 Sep-Oct;20(5):S588-92.




Wachler BS, Hiatt JA. Boxer Wachler Vision Institute, Beverly Hills, CA 90210, USA. b...@boxerwachler.com  From the full text: "...the refractive outcomes for >70% of the study population are not reported."  ABSTRACT  PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems.  METHODS: VISX and Alcon myopic wavefront laser in situ keratomileusis (LASIK) trials were analyzed based on public information available in the pre-market approval documents.  RESULTS: Clinical tests and outcomes reporting varied between pre-market approvals. One pre-market approval reported contrast sensitivity whereas the other did not, although data was collected in both studies. Based on the FDA definition of "accountability," one pre-market approval reported 12-month accountability of 97.7% although only 24.5% of patients were analyzed at that interval. One pre-market approval reported 6-month results whereas the other reported 6- and 12-month results. One pre-market approval reported grouped pre- and postoperative subjective survey results; the other reported individual changes in pre- to postoperative subjective symptoms.  

CONCLUSION: We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.


Inside the FDA







March, 2006

Inside the FDA

FDA post-approval studies

by Malvina B. Eydelman, M.D.



Eyeing the Perils of LASIK surgery     





Medical Device Safety







FDA: Under new leadership...AGAIN


News Release


Wednesday, March 15, 2006

Contact: HHS Press Office

(202) 690-6343




Secretary Leavitt Applauds Nomination of New FDA Chief


Says Dr. von Eschenbach brings vision and vitality to important agency


HHS Secretary Mike Leavitt today praised the nomination of Andrew C. von Eschenbach, M.D., to lead the Food and Drug Administration (FDA). The nomination was announced earlier today by President George W. Bush. Dr. von Eschenbach has served as acting FDA commissioner since September 2005.


“Andy is an inspired choice to provide permanent leadership at this critical agency. His career has been defined by his vision for progress in research and passion for the care of patients – two qualities which will serve the agency and the American public well,” Secretary Leavitt said.


“FDA needs permanent leadership to spur more innovation, improve drug safety, and help life-saving drugs reach patients faster. Andy understands these needs and will provide leadership to get the job done.”


FDA is the oldest consumer protection agency in the world, celebrating its 100th year of service. FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.


Dr. von Eschenbach has served as acting FDA commissioner since September 2005 concurrently with his position as director of the National Cancer Institute (NCI), to which he was named in January 2002.


Dr. von Eschenbach is a nationally recognized urologic surgeon, medical educator, and cancer advocate. He also is a cancer survivor. Prior to his appointment as director of NCI, Dr. von Eschenbach spent 25 years at the University of Texas M.D. Anderson Cancer Center in Houston, ultimately serving as executive vice president and chief academic officer.


A native of Philadelphia, Dr. von Eschenbach earned a Bachelor of Science degree from St. Joseph’s University in 1963 and his medical degree from Georgetown University School of Medicine in 1967. He completed residencies in general surgery and urology at Pennsylvania Hospital in Philadelphia and was then an instructor in urology at the University of Pennsylvania School of Medicine. From 1968 to 1971, Dr. von Eschenbach served as a Lieutenant Commander in the U.S. Navy Medical Corps.




Will it make a difference this time? Probably NOT!



Will it make a difference this time? Probably NOT!