See the posting by Dominic Morgan using the alias of "lasikdecisiondotcom"
at
http://bazell.newsvine.com/_news/2008/04/24/1450620-qa-fda-takes-a-closer-look-at-lasik?threadId=255136
Below is my presentation to the FDA's Ophthalmic Panel Meeting held April
25, 2008: My name is Dom Morgan. I am legally blind from my surgeons'
improper use of an investigational laser, a laser sanctioned by the FDA,
known to be responsible for damaging over 30 people. I had Retinopathy of
Prematurity, meaning that my retinas were structurally incomplete at
birth.
I was 20/50 and barely legal to drive when I had LASIK. I was never a
candidate. The intraocular pressure created by the suction ring destroyed
my
retinas. My problems are permanent. As retinal problems they will never be
addressed by a contact lens. I believe my doctor knew and did the
procedure
anyway. I was dropped from their clinical study. So were others. Those
data
were never re****ted to the FDA. The doctors sued me because I set up a
website and told the truth. I've addressed my concerns about LASIK to the
FDA for over five years, not only on my behalf, but also on behalf of
others. In 2003 I filed a petition regarding medical devices and safety of
refractive surgery, which was ignored. Help was offered by Ombudsman Les
Weinstein, and then retracted. My concerns today are with those needlessly
damaged by refractive surgery. Even with the most modern technology, there
are still of too many people writing me telling of the nightmares they now
live with on a daily basis. I received several hundred emails this past
year
from people seeking help. Many of those are depressed. Some of them have
confided that they want to commit suicide. And this is just through one
website. Having corresponded with many of those patients, I believe they
are
just ordinary people cause in unusual cir***stances. There is nothing
remarkable about them, certainly nothing to suggest perfectionism, or any
of
the other reasons that some LASIK doctors use to excuse their own bad
results. The FDA's capacity to oversee the refractive surgery industry is
in
my opinion no different than the doctors who have tarnished it. The FDA
has
been ineffective in overseeing investigational studies, ineffective in
enforcing the policies mandated for the industry, and ineffective in
providing thus far the protection that many of us here today should have
had. Everyone in this room today is here for a reason. Please do not allow
what is presented to you to continue falling on deaf ears. The public must
depend on government agencies like the FDA to protect them. In a recent
press release, ASCRS volunteered to contribute funding for the FDA study
on
LASIK complications and quality of life. The FDA has already received
copious amounts of criticism because of funding received from the
pharmaceutical industry. Essentially, industry funds the FDA, which
creates
conflicts of interest. I ask the panel how funding received from ASCRS is
any different. Most of the patents who have emailed my website feel
deceived
and lied to by surgeons who have exploited the public perception that
doctors are healers. Why should damaged patients trust an organization of
such surgeons any more than they trusted their own surgeon? Included with
my
submission today I would like to emphasize are two letters previously
written to the FDA, which are already public record. These letters apply
not
only to me, but many others: The letter written by Dr. Steven Friedman to
the FDA's Office of Criminal Investigation summarizes not only my
experience
and I believe the outright criminal activity of my doctors, but also
explains why the civil justice system does not work. The letter written by
Dr. James Salz, respected LASIK surgeon and principal investigator for
past
FDA studies emphasizes that I was not a proper candidate for LASIK and
tells
why. Also included are a few do***ents and previous correspondence I sent
to
the FDA. I believe this further sup****ts what I just outlined. My story
and
more can be found at lasikdecision.com. I ask the panel to recommend to
that
FDA conduct its own independent and unbiased study. Survey damaged LASIK
patients nationwide, and ask how many feel lied to by their LASIK doctors.
Conducted without funding from the industry, the results might be
believable. I would also ask that the criminal division of the FDA conduct
an investigation of specific doctors, such as mine, in regards to their
actions in dealing with many of us. I think a moratorium on advertising by
doctors is an intriguing idea. So much is made on patient selection but
more
should be done on doctor selection, maybe a website listing doctor
qualifications in a standardized, verified format. Thank you for your time
and I will gladly post any presentation unedited on my website.
---------------------------------------------------- The FDA considers all
complications as adverse events and request that everyone with
complications
file a MEDWATCH complaint. This can be done at: https(colon//)
This is very im****tant so that the FDA can get an accounting of the true
number of patients damaged, and I urge every one here who has mentioned
their complications to do so.
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