http://www.lasikfraud.com/news/archives/000199.html
Jim Dickinson
Editor, FDA Webview & FDA Review
A group of LASIK dissidents, led by injured patient Dean Kantis, have
launched a Web site called LasikFDA.com "to expose deceit, corruption, and
collusion by the FDA and the LASIK industry. You've read the hype about
the
10-minute miracle. Now get the truth." To disown confusion its look-alike
name might invite, its home page prominently declares: "This is not the
FDA
Lasik site. The FDA Lasik site is here," with a live link to CDRH's LASIK
page.
Heavily anchored to excerpted transcripts and video of presentations made
at
FDA's 4/25 Ophthalmic Devices Panel meeting on LASIK post-marketing
experience, the site's home page links to a statement by National Research
Center for Women and Families president Diana Zuckerman, an epidemiologist
saying: "There's very good information on the FDA Web site about the
risks,
but who reads the FDA Web site?"
The cite contends that at that FDA panel meeting, "Insiders acquainted
with
the FDA approval process for medical devices were horrified as one by one,
the presenters alleged deception by individual LASIK surgeons, cover ups
perpetrated by medical device manufacturers, and corruption at the level
of
the FDA itself. Compelling cases were made for massive violations of
federal
law, the failure of the FDA to monitor surgical facilities for LASIK, and
deliberate misclassification of severe complications as simple
side-effects,
as a means of securing premature FDA approval of the excimer laser.
"The mass media attended and filmed the April 25th hearing," the site
says,
before lamenting that "(n)evertheless, the substance of the above
allegations went mostly unre****ted, despite the presentation of four
completed post-LASIK suicides, including excerpts from two actual suicide
notes (these presentations are included in the videos at right). The
American Society of Cataract and Refractive Surgeons (ASCRS) asserted that
individuals with psychological issues post-LASIK certainly had
psychological
issues all along. To anyone without a preconceived bias, the ASCRS
position
seemed indefensible. Still, the mass media focused on a 95% percent
satisfaction rate, a statistic put forward by ASCRS, but not yet published
in their own peer-reviewed literature. Why?"
The site says its creation is an effort counter such impressions, saying
the
4/25 panel meeting "must be regarded as one of the most interesting
sociological dramas in modern medicine, one which is still being played
out.
This site chronicles the events leading up the meeting, including press
releases by the American Society of Cataract and Refractive Surgeons,
videos
by presenters on both sides, and the reaction of the American press.
"Judge for yourself the significance of these events, and come to your own
conclusions about LASIK, the industry behind it, and the FDA."
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Learn about Glenn Hagele, USAEyes, and Council for Refractive Surgery
Quality Assurance at the following web sites:
http://www.theglennhagelere****t.com
http://www.usaeyes.us
http://www.lasikpimp.com
http://www.lasikfraud.com
http://www.lasikdisaster.com
http://www.lifeafterlasik.com
http://www.lasik-flap.com/forum/viewforum.php?f=21
http://www.lasikscam.com/viewforum.php?f=21
http://www.jackholladay.com/avoid_this_doctor.html
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CRSQA (Council for Refractive Quality Assurance) is a referral service for
LASIK surgeons, operated by Glenn Hagele out of his home. Despite its
pretentious name, CRSQA is just a cynical marketing ploy that "certifies"
refractive surgeons willing to fork over $7,000 in the first year and
$5,000/year thereafter. In exchange, Glenn Hagele provides these surgeons
with a bogus seal of approval on his USAEYES.org web site to promote
their
practices. Don't be fooled by Glenn Hagele's advertising claims - CRSQA's
quality "standards" are actually below industry standards. Glenn Hagele
is
not qualified to issue certifications as he is not a doctor, but simply a
high school graduate with a single college course in marketing.
Out of 17,000 ophthalmologists in the US, about 30-50 pay Glenn Hagele to
market their practices. It is somewhat difficult to tell exactly what
ophthalmologists are members of CRSQA at any one time, as Glenn Hagele has
designed his web site in such a manner to implicitly suggest that 17,000
ophthalmologists are members.
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