TODAY THE LASIK INDUSTRY WILL BE TURNED UPSIDE DOWN...

 

THE LASIK INDUSTRY WILL BE TURNED UPSIDE DOWN!

THE NEXT IRS INVESTIGATION WILL BE INTO THE DIRECTORS AND COMMISSIONERS AT THE FDA, ASCRS, AND THE LIASONS REPRESENTING THE LASER MANUFACTURERS WHO CONTINUE TO FALSIFY ("COOK")SENSITIVE SAFETY DATA...   HERE'S WHY: Reference: http://www.bostoneyepain.org/my-personal-thoughts/    My Personal Thoughts: August, 2013 By Perry Rosenthal, M.D. Assistant Harvard Professor of Ophthalmology     "THE SCANDAL OF LASIK!" Imagine a surgical procedure being performed for cosmetic reasons and patient convenience on a healthy organ critical to our ability to function. Considering that this surgery neither treats nor prevents disease, what is the acceptable rate of serious and permanent complications? Shouldn't it be zero? How can we even consider a rate greater than those of vaccinations that, while also given to healthy people, provide invaluable disease-prevention benefits? LASIK/PRK laser surgeries do not.   How has it been possible that disastrous permanent complications of these surgeries have been ignored by the FDA? In this context, I have a confession to make. Despite my being aware of the many blinding complications of this surgery, having treated many of these patients at the Boston Foundation for Sight (which I founded), like my colleagues, I failed to act on my observations that a surgical procedure performed for non-medical reasons and that has been proven to have disastrous consequences in some, would be sanctioned by the FDA.   I did nothing until I became aware of a complication that had not been previously reported; suicide-provoking pain that is long-lasting and probably life-long. Why had this devastating complication not been reported in the past? I assumed that eye doctors had been misled because these eyes typically look normal and well healed. Moreover, we have been trained to believe that the cause of chronic eye pain can always be identified during traditional examinations and that if nothing is found to explain it, the pain must exist only in the minds of these patients. Moreover, as I discovered, the onset of this type of pain often occurs years after the surgery and their connection is easily dismissed. I thought that these factors probably accounted for its having being overlooked. I was wrong.   I did detailed examinations on 21 such patients and wrote a paper detailing the characteristics of this pain disease (corneal neuropathic centralized pain) in this group in which I explained why it differs from typical temporary post operative pain. I offered my theory about its mechanisms and included suggestions on how it might be possibly prevented or reduced.    As I began to read the history of LASIK and its complications     I became aware of the central role of the FDA in sanctioning these procedures.  However, a cursory look at the results of search engines provided a day's read. Where is the shame?    So I sent my paper to the FDA as documentation of this previously unreported complication despite being warned that they will not respond. I didn't believe it.   I was wrong. I sent it twice without the courtesy of an acknowledgement. Of course they could always say that the paper has no standing because it was rejected.    I would never have imagined that editors of scientific peer-reviewed journals, a for profit manufacturing/marketing industry and, in some cases, even practicing doctors would collaborate to hide these complications from the public and prospective patients. And what about the government agency whose primary responsibility is to protect the public (FDA/CDRH)?     http://bmctoday.net/crstodayeurope/2013/02/article.asp?f=ndyag-treatment-of-epithelial-ingrowth  and more than 28 million have been done world-wide. And it was predicted that at the current rate of 800,000 procedures per year, the available pool of surgical candidates is growing by 2 million eyes per year: http://bmctoday.net/crstoday/2011/08/article.asp?f=the-lasik-market-yesterdays-technology-or-poised-for-recovery     This is a huge industry with tentacles that reach the FDA. In the meantime, think about what will be happening to many of the people who will be undergoing these procedures ignorant of their possible life-destroying complications.  This paper was summarily rejected by a leading peer-reviewed journal in ophthalmology. I shrugged my shoulders and submitted it to one that specializes in corneal laser procedures, fully expecting it to be accepted.   It too was rejected outright. The reviewers' criticisms were impossible to address.   http://www.aao.org/publications/eyenet/200906/feature.cfm    "Because of the infrequency of this complication, it would take more than 15 years at an incredible cost to perform the studies they insisted would be needed by other journals. (They stated that they had no interest in looking at it again.) In other words their suggestions were totally unrealistic.   I was confused. So I sent the paper to world-class pain researchers for their opinions. All supported its being published. (One called my work "transformative".) Notably, both journals ignored my suggestion that at least one of the reviewers be an expert in pain. I began to wonder if they had a hidden agenda. Was I becoming paranoid? I have been accused as having an over-abundance of naivety.    But I can no longer be silent..."       Perry Rosenthal, MD Assistant Harvard Professor of Ophthalmology