Dickinson's FDA WEBVIEW (www.fdaweb.com)
Dickinson's FDA REVIEW
Dickinson's FDA Update
April 19, 2010
Dean Andrew Kantis
Founder/Editor
www.LifeAfterLasik.com
"Hurt LASIK Patient Network"
Dear Mr. Kantis:
You have asked for my objective observations on the FDA approval and post-market
surveillance of laswers used in the cosmetic vision enhancement surgical
procedure known as LASIK.
After researching all of the publicly accessible FDA documentation and a large
amount of non-FDA literature, including peer-reviewed journals, correspondence
between informed parties, and federal court documents, it is my carefully
considered opinion that:
(1) These lasers and associated hardware were respectively PMA-approved and
510(k)-cleared by FDA with egregiously insufficient evidence of their long-term
safety and effectiveness for the LASIK indication.
(2) FDA developed an unwise working relationship with the American Society of
Cataract and Refractive Surgery under which the falsely-based misperception that
LASIK has a 95% post-surgical no-defects rate was perpetuated by the agency,
seriously retarding the public realization that the defective vision rate is
actualy 20%-plus, or 20 times the incidence that FDA itself had said in a
guidance document was tolerable.
(3) Although it performed a token enforcement action in 2009 involving
inspection of some 20 LASIK-performing ambulatory surgical facilities and
issuance of a cautionary letter to the profession about its obligation to
include adverse event factors in members' advertising, FDA has not advised that
it has conducted any effective follow-up to these activities. Failure to visibly
follow-up in the face of multiple examples of continuing, even accelerating,
violations in the LASIK surgery industry is clear evidence of insincerity on
FDA's part and is suggestive that its unwise alliance with the ASCRS (see
preceding observationi) is continuing.
(4) FDA's 2009 decision to collaborate with the Department of Defense in a long
term study of LASIK's quality -of-life issues puts it in a conflict-of-interest
situation with the Department of the Navy, which conducts the majority of LASIk
procedures on active-duty Defense personnel for military purposes; personnel
performing these procedures have been accused of covering up adverse events and
being biased in favor of the procedure, citing data that may not be relevant to
the civilian population most at-risk for experiencing LASIK adverse events.
(5) There is sufficient adverse-event information in the public record for FDA
to issue a lay-language public warning about LASIK advising that one in every
five people who undergo this procedure will experience lifelong, sometimes
delayed, vision problems that may be so disabling that other medical conditions
will be caused, such as depression and suicidality.
I hope the foregoing observations are helpful.
Sincerely,
James G. Dickinson
Editor and President
Posted by Admin at April 20, 2010 01:44 AM