WHICH LASIK SURGEONS HAVE A FINANCIALLY-BIASED INTEREST IN KEEPING LASIK LOOKING SAFE AND COULD BE "COOKING" THE SAFETY STUDIES FOR PROFIT?

WHICH LASIK SURGEONS HAVE A FINANCIALLY-BIASED INTEREST IN KEEPING LASIK LOOKING SAFE AND COULD BE "COOKING" THE SAFETY STUDIES FOR PROFIT?

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.

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:
 

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

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

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

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

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.

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.eyeworld.org/article.php?sid=4653
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 

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. 

http://www.osnsupersite.com/view.aspx?rid=20499 

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. 

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

 

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?

http://www.airwarriors.com/forum/showthread.php/148182-Starbursting-af

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… Originally Posted by cdmike112

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.

Originally Posted by eddie

Don't tell anyone. Wait awhile.

             Originally Posted by spitfiremkxiv

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.”

“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.”