Copyright Dickinson FDA Webview at www.fdaweb.com. Republished by permission.

05-08-2015

Attaching 1,073 signatures mostly from other purported victims of LASIK eye surgery, activist Paula Cofer 5/8 asked FDA acting commissioner Stephen Ostroff to reopen for consideration a petition from former CDRH ophthalmic device branch chief Morris Waxler that was denied last summer. The petition sought the market withdrawal of LASIK-indicated device and a public health advisory. In her letter, Cofer alleges that the denial was “presumably” directed by CDRH ophthalmic devices director Malvina Eydelman who, she wrote, “has a history of protecting industry interests over public health … It is clear that under the leadership of ophthalmologist Malvina Eydelman, MD, the FDA division that oversees LASIK devices has been ‘captured’ by industry.”

The letter says Waxler asserted that “LASIK manufacturers and their collaborators successfully pressured FDA to classify surgically-induced vision problems (halos, starburst, ghosted images and glare) and chronic dry eyes as mere ‘symptoms’ so that manufacturers could claim that the adverse event rate is less than 1%. ‘The true adverse event rate six months or more post-LASIK is at least 20 times the FDA approvable rate of 1%,’ he says.”

Cofer says FDA “has failed to take action on several other citizen petitions asking for a variety of actions against LASIK, several reports of LASIK-related suicides, numerous letters and emails from the public concerning LASIK problems, countless false and misleading LASIK ads promoting specific LASIK devices, and hundreds of LASIK-injury reports filed with the agency by LASIK patients through MedWatch.”

“What seems to be lost in the LASIK controversy,” the letter concludes, “is the simple fact that LASIK is unnecessary. Visual refractive error is not a disease requiring surgical treatment. Safer alternatives ─ namely glasses and contact lenses ─ are widely available.”