In some of the most one-sided journalism that I have seen, Diane Sawyer and ABC's World News Tonight  reported on the safety of LASIK surgery.  The story was based on an interview with Morris Waxler, a former FDA official who was involved in the approval process of LASIK in the 1990's. 

I take exception with many points in this story, including:

  • Diane Sawyer introduces Waxler as the "official who led the drive to approve the procedure."  As an FDA official, he led no such drive, his job with the FDA would have been to review clinical results and either recommend or strike down LASIK's approval.  He was not involved in the clinical trial process itself.
  • The reporter asks Waxler if he would ever recommend LASIK surgery to anyone interested in the procedure. His response, "no, absolutely not."  Although he is introduced as "Dr. Waxler," he is not an MD, he has a PhD.  I would love to know what clinical experience he purports to have.
  • Waxler states that people don't understand that LASIK "is not like getting your nails done."  I agree, LASIK is not a manicure, it is surgery.  I think this is certainly conveyed to all of my patients!
  • The reports states that "compromised cornea can develop microscopic scar tissue and cause vision problems."  This is simply not true.
  • Waxler claims that 50% of LASIK patients have side effects and 33% continue to need glasses or contact lenses.  I do not know where he gets his data, this is simply not true!  If these claims were true, no one would opt for the procedure.

The FDA is in the process of reviewing long term LASIK results.  One study, USAEyes CORE survey, found:

  • 99% report quality of life as expected, better, or much
    better
  • 98% day vision as expected, better, or much better
  • 98% no complications or issues are seldom problematic
  • 98% would recommend surgery to family and friends.
  • 97% would have surgery again, knowing what they know now
  • 96% wear corrective lenses as often as expected, less, or
    much less than expected
  • 96% report post op vision without lenses as expected, better,
    or much better than expected when compared to preop vision with lenses
  • 96% report overall quality of vision as expected, better,
    or much better than expected
  • 91% no complications at any time
  • 91% night vision as expected, better, or much better
  • 7% complications seldom problematic
    – yet 91% of these same patients would have surgery again
  • 2% complications frequent or always problematic
    – yet 22% of f these same patients would have surgery again

These survey results makes one take pause and wonder where Waxler gets his statistics from and what his motivations might be.  Since retiring from the FDA, Waxler now runs Waxler Regulatory Consultancy, LLC, which "provide consultant services on Food and Drug Agency regulatory issues for the entire life cycle of your medical
devices."  One wonders if one of his clients might be an anti-LASIK organization?

R. Doyle Stulting, MD, PhD, president of the American Society of Cataract and Refractive Sugeons (ASCRS) has also had something to say about Waxler in the past:

“In summary, your letter is filled with false statements, incorrect
citations of the published literature, references that do not fairly
represent the existing literature, mischaracterization of a study
protocol you have never seen, incorrect reference to outcomes of PRK as
if they were for LASIK, citation of results for a laser designed two
decades ago as if were representative of modern lasers,
mischaracterization of results from older lasers as “better than most,”
reference of a graph that does not exist in the reference you cite, and
misrepresentations of the actual performance of modern excimer lasers
for the correction of refractive errors”

I am a little surprised at World News Tonight for reporting in such a biased manner.  Shame on you, Diane Sawyer!

Here is the story.

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