First, lets listen to Schallhorn's paid testimony at the Emergency Opthalmic LASIK Device Panel in DC on April 25th, 2008:
Steven Schallhorn's Ties
to Navy Ophthalmologist and DoD (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)
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:
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
Look at this, here it is all spelled out, for you to see the
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
On March 17, 2008, the America Academy of Ophthalmology (AAO) issued a press
release announcing, “Organized Ophthalmology and Government Agencies Discuss
Study Design for Dissatisfied LASIK Patient Clinical Trial”.
On April 7, 2008, ASCRS issued a similar press release:
On April 24, 2008, Bloomberg.com quoted Daniel Schultz, then-director of
FDA’s Center for Devices and Radiological Health (CDRH), as saying that the
LASIK study involving organized ophthalmology would begin no later than 2009:
“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.”
On April 25, 2008, the FDA held a public meeting of the Ophthalmic Devices
advisory panel to discuss post-marketing experience with LASIK. LASIK patients,
family members of LASIK patients, physicians, psychologists, and optometrists
spoke about the high incidence of LASIK complications and the emotional toll
that a bad outcome from LASIK takes on patients. Several LASIK-related
suicides and suicide attempts were reported at the meeting. Organized
ophthalmology representatives and active-duty and retired Navy and Army
physicians gave testimony asserting that LASIK is safe and effective, and denied
any connection between a bad outcome from LASIK and depression.
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.
ASCRS paid Dr.
Morse’s travel expenses to attend the hearing.
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
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
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:
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 April, 2009, ASCRS held its annual convention in San Francisco. At the
convention, LASIK surgeons performed skits making fun of suicidal LASIK
patients. One skit poked fun at patients who complain of halos and glare
after refractive surgery. Another skit featured Dr. Parag Majmudar as
"Dr. I. M. Suicidal" singing of "pushing the boundaries of
ethics". The skits were published on YouTube by Dr. Majmudar.
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.
On October 15, 2009, the FDA announced that it had launched a collaborative study
with the National Eye Institute (NEI) and the Department of Defense to examine
the potential impact on quality of life from LASIK.
“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.”
The FDA did not, however, explain the sudden departure of ‘organized
ophthalmology’ from the proposed LASIK study.
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
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.
To date, the FDA has not explained the 3-plus year delay (from the time it
approached ASCRS) in investigating LASIK dissatisfaction. Although new
safety concerns have been raised, LASIK continues to be performed unabated in
direct conflict with FDA’s mission to protect the American public from unsafe
medical devices. Considering the elective nature of LASIK and the fact
that LASIK carries significant risk to patients’ vital sense of sight, this is
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
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: