ARE THE NAVY'S TOP OPHTHALMOLOGISTS POSSIBLY "COOKING THE LASIK SAFETY STUDIES?" IF CAUGHT, THIS WOULD BE A MEDICAL CRIME CORRECT?
Ties to Navy Ophthalmologist and Department of Defense:(They are handling the "LASIK QUALITY OF LIFE STUDIES" and before the study has even begun, they are boasting a 95.4% patient satisfaction rate that it will AGAIN PROVE LASIK to be safe and effective...WITH NO KNOWN LONG TERM DAMAGES!)
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
HERE ARE THE PIECES TO THE "THE LASIK BLUEPRINT PUZZLE" that further shows how the Navy's Top Ophthalmologists have tightly controlled the "SAFETY" studies for LASIK:
Jennifer Morse (NAVY Psychologist) addresses the "Emergency LASIK Ophthalmic Panel stating that she was paid by the LASIK INDUSTRY, ASCRS, to present her statements...and also stated that anyone having a bad outcome from LASIK and then became depressed had previous pyschological disorders...and that LASIK couldn't be held responsible for such depression..." at the April 25th, 2008 FDA Hearing:
Richard Lindstrom (ASCRS ex President/Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies and previous ASCRS President...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Peter McDonnell (Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Scott Barnes on behalf of Doyle Stulting (ASCRS current President/Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies and previous ASCRS President...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Scott Barnes (ARMY Ophthalmologist) that oversaw special/secret operations and was also involved in the LASIK safety studies...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing: (By the way...it should be known to the public that doesn't hear the other side to this story, that Mr. Barnes is wanting LASIK because he's comparing acts of war, so of course someone getting by with no glasses falling off or contacts falling out, is going to be preferred during war and fighting scenarios, but why isn't he comparing this to those in daily jobs behind a computer, driving a truck at night, etc... Do you see the point? Here's what Mr. Barnes again failed to mention:)
ARMY SURGEONS AT FORT BRAGG DROP LASIK IN FAVOR OF PRK, September, 2008 EyeNet Magazine: "At Fort Bragg in North Carolina, Army surgeons have moved toward surface ablation [PRK] procedures for all refractive surgery candidates because of the rare but real potential for traumatic flap dislocations after LASIK."
Steven Schallhorn (NAVY Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies at the Navy and resides on the board of Optical Express...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Jennifer Morse (NAVY Psychologist) addresses the "Emergency LASIK Ophthalmic Panel stating that she was paid by the LASIK INDUSTRY, ASCRS, to present her statements...and also stated that anyone having a bad outcome from LASIK and then became depressed had previous pyschological disorders...and that LASIK couldn't be held responsible for such depression..." at the April 25th, 2008 FDA Hearing:
Richard Lindstrom (ASCRS ex President/Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies and previous ASCRS President...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Peter McDonnell (Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Scott Barnes on behalf of Doyle Stulting (ASCRS current President/Ophthalmologist) that oversaw and still oversees many of the LASIK safety studies and previous ASCRS President...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing:
Scott Barnes (ARMY Ophthalmologist) that oversaw special/secret operations and was also involved in the LASIK safety studies...addresses the "Emergency LASIK Ophthalmic Panel stating that he was paid to present his statements by the AAO" at the April 25th, 2008 FDA Hearing: (By the way...it should be known to the public that doesn't hear the other side to this story, that Mr. Barnes is wanting LASIK because he's comparing acts of war, so of course someone getting by with no glasses falling off or contacts falling out, is going to be preferred during war and fighting scenarios, but why isn't he comparing this to those in daily jobs behind a computer, driving a truck at night, etc... Do you see the point? Here's what Mr. Barnes again failed to mention:)
ARMY SURGEONS AT FORT BRAGG DROP LASIK IN FAVOR OF PRK, September, 2008 EyeNet Magazine: "At Fort Bragg in North Carolina, Army surgeons have moved toward surface ablation [PRK] procedures for all refractive surgery candidates because of the rare but real potential for traumatic flap dislocations after LASIK."
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
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”. http://www.aao.org/newsroom/release/20080317.cfm
On April 7, 2008, ASCRS issued a similar press release:
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
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
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.”
http://www.bloomberg.com/apps/news?pid=20601124&refer=home&sid=aX6SKlifKQvU
http://www.bloomberg.com/apps/news?pid=20601124&refer=home&sid=aX6SKlifKQvU
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. Patients had to come at their "OWN" expense and speak out as shown here:
http://www.youtube.com/results?search_query=lasik+hearing&aq=f
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.
http://www.youtube.com/watch?v=_TEejJ7J22I
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.”
http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-02.pdf
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.”
http://www.osnsupersite.com/view.aspx?rid=27476
-Proof that Schallhorn and others
may have already "cooked" the outcome-
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 to the same conclusion," he predicted.bbSource: 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. http://www.osnsupersite.com/view.aspx?rid=20499 .
-Dr. Schallhorn has ties to AMO,
the parent company of IntraLase-
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. http://www.tlcvision.com/centers/lajolla/doctors.fxml#item3. 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 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.”
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm187351.htm
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 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. 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 unacceptable.
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.
http://www.osnsupersite.com/view.aspx?rid=20499
In January 2007, Forbes.com announced that IntraLase was acquired by Advanced Medical Optics (AMO). http://www.forbes.com/2007/01/08/advanced-medical-optics-markets-equity-cx_jl_0108markets09.html
In June 2007, EyeWorld magazine reported that Dr. Schallhorn was a consultant for Advanced Medical Optics (AMO), parent company of IntraLase. http://www.eyeworld.org/article-reducing-hoas-to-improve-quality-of-vision
In November 2007, EyeWorld magazine reported that Dr. Schallhorn had financial interests with Advanced Medical Optics.
http://www.eyeworld.org/article-femto-laser-for-intrastromal-ablation
Dr Schallhorn's daughter, Erin Schallhorn, was employed by AMO at the time the defense contract was awarded.
http://www.linkedin.com/pub/erin-schallhorn/3/a5b/924
The article at the following link states that Erin Schallhorn is the daughter of Dr. Steve Schallhorn:
http://legacy.signonsandiego.com/uniontrib/20070218/news_lz1j18seeduty.html
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