As such incapacities provoke public criticism, FDA has answered by applying central control over the news media, lest lack of confidence in its mission be spread. As just one example, our questions since mid-March to find out who is conducting the joint FDA-Department of Defense study of LASIK post-surgical outcomes and the study's protocol have been routinely deflected by the FDA Press Office, the sole entry-point into the agency for the news media. Why? Nobody, not even principal deputy commissioner Joshua Sharfstein, who heads the agency's much-promoted Transparency Task Force, will answer. The hypothesis this presents is: Was the FDA-DoD LASIK outcomes study given to pro-LASIK Navy surgeons to achieve a biased result that would (a) vindicate CDRH's 1997 approval of the LASIK indication despite the chief approver's public recanting of that decision since, and (b) rescue an entire industry from liability lawsuits?
Read more...May 2010 Archives
"I am Morris Waxler, Ph.D., former Food and Drug Administration (FDA) official in charge of approving laser vision correction (LASIK) devices between 1996-2000 (resume attached). Thanks to pointed questioning by LASIK-injured patients, I have re-examined the data FDA used to approve LASIK devices as well as the data from subsequent scientific studies and now conclude that LASIK-induced risks of permanent loss of vision overwhelm the temporary benefit of visual acuity improvement."
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Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and "I will do everything I can to block approval of such a study." Waxler, who has recently said the agency's approval of LASIK devices was a mistake, defined keratectasia as "a rare but serious complication of laser vision correction of any refractive errors."
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