The following disclosures are from the LASIK WORLD LITERATURE
REVIEW (95.4% satisfaction POS article) which was published in 2009.
Richard Lindstrom takes the prize. (I'm still trying to understand
Schallhorn's involvement in a $45 million Defense contract -- which was
announced immediately following Schallhorn's retirement from the Navy --
awarded to IntraLase, which was acquired by Advanced Medical Optics, in which
Schallhorn has financial interests.)
Jennifer Morse ASCRS consultant and former Navy Program Director for Psychiatry in San Diego, talked about the benefits of LASIK in military and civilian populations, and asserted that there is no scientific evidence of any direct link between LASIK and depression or suicide. Several months later at an AAO annual meeting, Dr. Morse spoke about dissatisfied LASIK patients, saying there must be some neurologic disconnect between what their eyes are seeing and what their brain is processing. It should be known that ASCRS paid all of Dr. Morse’s travel expenses to attend the hearing and produce a "biased testimony" that many say was a "cooked testimony" to make sure there were no connections between having a bad LASIK outcome and having depression.
Jennifer Morse ASCRS consultant and former Navy Program Director for Psychiatry in San Diego, talked about the benefits of LASIK in military and civilian populations, and asserted that there is no scientific evidence of any direct link between LASIK and depression or suicide. Several months later at an AAO annual meeting, Dr. Morse spoke about dissatisfied LASIK patients, saying there must be some neurologic disconnect between what their eyes are seeing and what their brain is processing. It should be known that ASCRS paid all of Dr. Morse’s travel expenses to attend the hearing and produce a "biased testimony" that many say was a "cooked testimony" to make sure there were no connections between having a bad LASIK outcome and having depression.
http://www.eyeworld.org/article.php?sid=4653
http://www.youtube.com/watch?v=_TEejJ7J22I
Kerry D. Solomon is a consultant for
Alcon Laboratories, Inc., Allergan, Inc.,
Advanced Medical Optics, Advanced Vision Research, Bausch & Lomb,
Incorporated, Eyemaginations, Inc., and QLT.
Eric D. Donnenfeld is a consultant for
Alcon Laboratories, Inc., Allergan, Inc., Advanced Medical Optics,
Advanced Vision Research, Bausch & Lomb, Incorporated, Eyemaginations,
Inc., Pfizer, QLT, TLC, and Wavetec.
Richard L. Lindstrom is a consultant
for AcuFocus Inc, Advanced Medical Optics, Advanced Refractive Technologies,
Alcon Laboratories, AVS, Bausch and Lomb, Inc, BioSyntrx, Clarity
Ophthalmics, Clear Sight, CoDa Therapeutics, EBV Partners, Egg Factory,
Encore, Eyemaginations, Inc, Glaukos Corporation, High Performance Optics,
Improve Your Vision, I-Therapeutix, Lensar, LenSX, S.V.L. Sciences,
Midwest Surgical Services, Minnesota Eye Consultants, P.A., Neurovision,
NuLens, OccuLogix, Ocular Surgery News/Slack, Omeros Corporation, Pixel Optics,
Quest, Refractec, RXVP, Supply Eye, 3-D Vision Systems, TCL Vision, Tracey
Technologies, Versant, and Vision Solutions Technologies. Supported in part by the American
Society of Cataract and Refractive Surgery Foundation, Fairfax, Virginia;
NIH/NEI EY-014793 (vision core); and an unrestricted grant to MUSC-SEI
from Research to Prevent Blindness, New York, NY.
Steven Schallhorn is a consultant and many feel has a biased/financial incentive to keep LASIK SAFETY STUDIES looking good (COOKED) so he can continue to reap millions!
More of Steve Schallhorn/Navy/Femtosecond Laser:
More of Steve Schallhorn/Navy/Femtosecond Laser:
Ties
to Navy Ophthalmologist and Department of Defense:
(they are handling the LASIK quality of life study shown here, again, before
the study has even begun, they are boasting a 95.4% patient satisfaction rate
and that it will prove LASIK to be safe and effective)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186858.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186858.htm
The Department of Defense and Navy are covering all of this up. They control the fabricated studies, and then report back to the FDA that LASIK is safe. They try to back it up using “navy and army guys in the field of battle and in “live or die” “intense situations,” which of course they will do better than having to wear contacts or glasses! But you can’t compare that to daily, un battle like situations behind a desk, on the computer, driving a car, as eye pain post surgery is “UNACCECPTABLE” etc… Below is a timeline, showing a huge “medical cover-up” with a $45 Million dollar DOD contract on Intralase: “the laser that never had any clinical studies, yet Dr. Steven Schallhorn, who has financial interests in AMO parent company, owns an interest in the company that received a lot of these profits, one month after he resigned from the DOD…” This is corrupt! Now the Navy is urging “happy patients” to go online and issue “happy” comments here:
www.regulations.gov
For clarification, very few people ever
submit a comments to the LASIK docket on www.regulations.gov . It's not
like MedWatch reports on the FDA’s website. When you have 15
submissions on the LASIK docket from one source, that sticks out like a sore thumb.
And that source just happens to be the Navy, who is supposed to conduct an
investigation of LASIK for the FDA?.... Here is what Sargeant Scott Barnes said at the FDA Panel I spoke
at: http://www.youtube.com/watch?v=AVFh0vNX60M
Look at this, here it is all spelled out, for you to see the
blueprint unfold:
On
March 10, 2008 an online publication of the America Society of Cataract and
Refractive Surgery (ASCRS) reported:
“In a ground breaking interaction, the U.S. Food
and Drug Administration (FDA), approached the American Society of Cataract and
Refractive Surgery (ASCRS) in the fall of 2006 for guidance in designing
a study to that would identify extremely dissatisfied post-LASIK patients,
define their significant symptoms, and the impact of those symptoms on quality
of life.”
http://www.eyeworld.org/ewweek.php?id=507
http://www.eyeworld.org/ewweek.php?id=507
http://www.aao.org/newsroom/release/20080317.cfm
http://www.ascrs.org/press_releases/ASCRS-TO-PARTICIPATE-IN-AND-CO-FUND-STUDY-ON-POST-LASIK-QUALITY-OF-LIFE-WITH-US-FOOD-AND-DRUG-ADMINISTRATION.cfm
“The Food and Drug
Administration, working with doctors' groups and the National Eye Institute,
plans to study how Lasik affects patients' quality of life no later than
next year, Daniel Schultz, head of the agency's medical devices center,
said today. Identifying why complications occur will help those considering
Lasik make more educated choices, he said.”
http://www.bloomberg.com/apps/news?pid=20601124&refer=home&sid=aX6SKlifKQvU
http://www.bloomberg.com/apps/news?pid=20601124&refer=home&sid=aX6SKlifKQvU
At
the public hearing, Dr. Jennifer Morse, ASCRS consultant and former Navy
Program Director for Psychiatry in San Diego, talked about the benefits of
LASIK in military and civilian populations, and asserted that there is no
scientific evidence of any direct link between LASIK and depression or suicide.
Several months later at an AAO annual meeting, Dr. Morse spoke about
dissatisfied LASIK patients, saying there must be some neurologic disconnect
between what their eyes are seeing and what their brain is processing.
LASIK surgeon, Dr. Steve Schallhorn who retired from the
Navy in early 2007, also spoke at the April, 2008 FDA hearing. Dr. Schallhorn
is a paid medical malpractice defense expert witness, has made public
statements and published literature denying connection between a poor LASIK
outcome and diminished quality of life, and is currently medical director of
one of the largest corporate providers of LASIK in the world. Said Schallhorn:
“While in the Navy, I founded
the Department of Defense Refractive Surgery Program and directed the Navy
program since its inception in 1993… For disclosures, I currently [sic] as a
consultant to AMO, a company that markets an excimer laser… LASIK is safe and
effective… Patient satisfaction after LASIK is excellent, higher than that
reported for other forms of elective surgery.”
On April 8, 2008, just prior to the FDA hearing, Dr.
Schallhorn was quoted in OSN Supersite online saying:
"I think it's important
that there's an appreciation that what we're talking about here is not the
safety and effectiveness of LASIK. That has never been an issue.”
Dr. Schallhorn was quoted in a December, 2009 article in the
Journal of the American Medical Association (JAMA) asserting that the FDA LASIK
study will find that LASIK is safe and effective and improves patients’ quality
of life.
Steven C. Schallhorn, MD,
chairman of the Optical Express International Medical Advisory Board, said he
is confident that once the quality-of-life issues are studied, LASIK will be
shown to be even more safe and effective. Schallhorn, who is currently a
consultant to 2 LASIK companies, bases his opinion on his prior work as a
captain in the Navy… "But in the context of the military and looking at
issues of quality of life and the impact LASIK has, it is not only a
life-changing event, but a performance-enhancing procedure," Schallhorn
said. "The FDA study will come tothe same conclusion," he predicted.
Source: Mitka M. FDA focuses on
quality-of-life issues for patients following LASIK surgery. JAMA. 2009 Dec
9;302(22):2420, 2422.
Interestingly, in December 2006,
approximately one month before Dr. Schallhorn’s retirement from the Navy, IntraLase
announced that the Department of Defense had awarded the company a $45 million,
5-year contract to supply its FS femtosecond (LASIK flap maker) lasers to the
U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies.
Dr. Schallhorn has ties to AMO, the parent company of
IntraLase (see Exhibit 1).
A third Navy physician, David J. Tanzer, M.D., Program Director
of the Navy Refractive Surgery Program in San Diego, was an invited guest
speaker at the April, 2008 FDA hearing. Dr. Tanzer asserted that LASIK is
safer than contact lenses. Dr. Tanzer emphasized the success and operational
benefits of LASIK in the military, and reported that satisfaction is high. Dr.
Tanzer is co-author of a February 2009 peer-reviewed study with Dr. Morse and
Dr. Schallhorn which states that patients who are depressed before LASIK are
more likely to be dissatisfied with their vision after LASIK. Dr. Tanzer has
published several papers with Dr. Schallhorn, all favorable to LASIK. TLC Laser
Eye Centers, a large corporate provider of LASIK, lists Dr. Tanzer among its
LASIK surgeons on the company’s website.
Also appearing at the April, 2008 FDA hearing was Lt. Col.
Scott Barnes, MD, an Army eye surgeon, who made an impassioned plea on behalf
of soldiers at Fort Bragg in North Carolina:
"Please don't take
[LASIK] away from us." http://www.youtube.com/watch?v=AVFh0vNX60M
However, Lt. Col. Scott Barnes, MD coauthored an article in
the July, 2008 issue of Current Opinion in Ophthalmology, which apparently
contradicts his FDA testimony:
"At Fort Bragg, North
Carolina, the Army surgeons have moved [from LASIK] to 100% surface
ablation in the past 2 years; the five known traumatic flap dislocations (out
of 2500 procedures) due to 'typical' soldier activities contributed to this
change but not as much as an analysis of the visual outcomes."
Obviously, Lt. Col. Scott Barnes was already aware of the
potential for traumatic flap dislocation and poorer visual outcomes with LASIK
eye surgery when he testified.
In May 2009, Scott Tolchin, a LASIK patient advocate, sent a
letter to members of the U.S. House of Representatives Committee on Energy and
Commerce and Subcommittee on Oversight and Investigations and others members of
Congress seeking an immediate moratorium on the use of excimer lasers for LASIK
surgery based on an approximate 20 percent incidence of complications,
including dry eyes and night vision problems, reported by patients in FDA LASIK
clinical trials. The letter states, in part:
The FDA announced that further
study of LASIK dissatisfaction was needed and reported that it had formed an
unprecedented partnership with LASIK professional groups to conduct a
prospective LASIK study to begin in 2009. The proposed study amounts to putting
the fox in charge of the hen house. Surgeons selected to lead the study
include those with direct ties to LASIK device manufactures - a clear
conflict of interest.
“Phase 2 will evaluate the quality of life and
satisfaction following LASIK as reported by patients in a select, active duty
population treated at the Navy Refractive Surgery Center at Naval Medical
Center San Diego.”
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm187351.htm
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm187351.htm
In November 2009, the FDA reopened a public docket to
continue to receive public comments to assist the agency in identifying ways in
which it can improve its public outreach efforts regarding the safety and
effectiveness of LASIK devices. Recently, many of the positive comments
about LASIK have been submitted by military LASIK patients at the direction of
Navy LASIK surgeons in an obvious attempt to slant the FDA's LASIK
investigation findings.
In light of the financial conflicts of interest and bias
exhibited by current and former Department of Defense physicians, and tainting
of the public docket, the FDA should remove the Navy from phase 2 of the
proposed LASIK study.
EXHIBIT 1
In December 2006, approximately one month before Dr.
Schallhorn’s retirement from the Navy, IntraLase announced that the
Department of Defense had awarded the company a $45 million, 5-year contract to
supply its FS femtosecond (LASIK flap maker) lasers to the U.S. Army, Navy, Air
Force, Marine Corps and federal civilian agencies.
In January 2007, Forbes.com
announced that IntraLase was acquired by Advanced Medical Optics (AMO).
In June 2007, EyeWorld magazine reported that Dr.
Schallhorn was a consultant for Advanced Medical Optics (AMO), parent company
of IntraLase.
In November 2007, EyeWorld magazine reported that Dr.
Schallhorn had financial interests with Advanced Medical Optics.
Dr. Schallhorn's daughter, Erin Schallhorn, was employed
by AMO at the time the defense contract was awarded.
The article at the following link states that Erin
Schallhorn is the daughter of Dr. Steve Schallhorn:
CAN ANYONE EXPLAIN TO ME WHY RESEARCH TO PREVENT BLINDNESS IS FUNDING THIS KIND OF JUNK SCIENCE...CALLED LASIK, THE ELECTIVE SURGERY THAT WASN'T EVEN NEEDED IN THE FIRST PLACE, THAT TAKES A PERFECTLY HEALTHY EYE AND MAKES IT SICK AND DISEASED FOR LIFE? LETS SEE WHO AT THE NAVY IS INVOLVED INPROFITING FROM SAFE LASIK SAFETY STUDIES SHALL WE?
Col. Scott D. Barnes, MD, is stationed at Womack Army
Medical Center, Fort Bragg, NC 28310. He can be reached at COL Scott
Barnes, Dept. of Ophthalmology-WAMC, Fort Bragg, NC 28310; 910-907-7921
910-907-7921 e-mail: scott.d.barnes@us.army.mil.
Lt. Col. Charles D. Reilly, MD, can be reached at 59
SSS/SGO2E, Wilford Hall USAF Medical Center, Lackland AFB, 2200 Bergquest
Drive, Suite 1, San Antonio, TX 78236-5300; 210-292-2010
; 210-292-2010
fax: 210-292-2313; Email: charles.reilly@lackland.af.mil.
Steven C. Schallhorn, MD, can be reached at
Email: scschallhorn@yahoo.com .
Capt. David J. Tanzer, MD, can be reached at Naval
Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92135; 619-532-6700
619-532-6700
Email: david.tanzer@med.navy.mil .
LETS SEE WHAT SCHALLHORN'S OWN
NAVY RECRUITS ARE SAYING ABOUT HIM?
Mention of the infamous Steven Schallhorn (many opinions say he controlled a lot of the LASIK studies and possibly falsified or doctored them up while in the Navy and made a fortune from the Intralase Femtosecond laser which really never went through any FDA Approvals, somehow side stepped the FDA approval/trials process) below…
I had
CustomVue PRK on Nov. 20th 2008. I am currently just under 5 months post op,
20/15 in both eyes but still experienceing some starbursting. It has slowly
gotten better over the past month. I was wondering what other peoples
experience has been and how long it took for their starbursting to deminish.
Don't tell anyone. Wait awhile.
To quote
a Navy doc during my recent eye exam:
"Statistics show that pilots and applicants experience very few PRK
complications compared to the rest of the population."
Don't be the abnormal
applicant that has starbursts.
“Interesting is not exactly the word I
used.”
“The bottom line is that unless the starbursts are ridiculously bad, they will not be detected in an eye exam -- it is almost completely subjective. It is also almost completely disqualifying.”
“The bottom line is that unless the starbursts are ridiculously bad, they will not be detected in an eye exam -- it is almost completely subjective. It is also almost completely disqualifying.”
“As a little side note, the former head of Navy Refractive Surgery, (Steven Schallhorn) who developed the Refractive Surgery program for the
Navy and Air Force was an F-14 pilot before going to med school (TOPGUN
Instructor, highest score ever recorded in a scored ACM exercise at the annual
F-14 fighter derby, real underachiever). He claims that he had
horrible starbursts and actually thought it was normal before he became an
ophthalmologist.”
“One of the most significant indicators or starbursts and glare is pupil size vs. treatment zone size. Do you know the size of your fully dilated pupil and the size of the area of your cornea that was treated (it should be on your surgical records)? The other common indicators are bad surgeons and bad luck.”
“One of the most significant indicators or starbursts and glare is pupil size vs. treatment zone size. Do you know the size of your fully dilated pupil and the size of the area of your cornea that was treated (it should be on your surgical records)? The other common indicators are bad surgeons and bad luck.”
