LASIK Founder Files NDA for LASIK Injury-healing Drug

Reprinted with permission from www.fdaweb.com
03/09/2012

David Muller, who as founder and CEO of Summit Technology gained in 1996 the first excimer laser approval for the controversial LASIK vision correction surgical procedure, announced 3/8 the submission of an NDA for VibeX (riboflavin ophthalmic solution)/KXL System to be used in treating corneal damage often associated with LASIK. The announcement came from his new company Waltham, MA-based Avedro Inc., which Muller formed with venture capital backing in 2007 after Summit was acquired by Alcon.

The new NDA seeks an indication for the treatment of keratoconus (a naturally occurring disease in which the cornea distends in a cone shape) and corneal ectasia following refractive surgery (LASIK). Morris Waxler, the CDRH branch chief who led the approval of Muller’s device in 1996 and others like it, is now aggressively seeking the removal of their LASIK indication based on a higher permanent injury rate from the LASIK procedure than disclosed by the sponsors in their data submissions.

Avedro’s news release quoted Cornea and Laser Eye Institute medical monitor and director Peter Hersh as saying that the “ophthalmology community is now looking forward to the possibility of offering cross-linking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need. Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Cross-linking has the promise of stabilizing these progressive corneal disorders and maintaining patients’ visual function over time.”

Corneal collagen cross-linking with riboflavin and ultraviolet light is described by the National Keratoconus Foundation as a process that increases natural collagen crosslinks in the cornea, thus strengthening it and preventing it from further bulging out. The treatment’s possible extension to treat post-LASIK ectasia was recognized by FDA last year as deserving of orphan drug designation, offering seven years market exclusivity. Avedro’s news release said the VibeX/KXL System for corneal collagen cross-linking received the European CE Mark in 2010 and has been commercially available internationally since then.

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Related:

Watch video of an American Investigator report concerning David Muller, Summit Technology, and the scandal surrounding FDA leak of competitor’s, VISX Inc., documents. Watch

Read Jim Dickinson’s March 1999 article on the 1995 VISX Inc. document leak to rival Summit Technology’s then-President, David Muller: [Capitol] Hill closes file on device secrets leak: ex-reviewer did it. Read article

Dr. Kim Robbins, MD, Robbins Eye Center complaint

December 31, 2011

On 12/27/2011, the LASIK industry watchdog group, LASIK Surgery Watch (LSW), sent a letter to the FDA’s Center for Devices and Radiological Health requesting “that the FDA take immediate action to stop deceptive and misleading advertising of LASIK by Kim Robbins, M.D.”

The letter, addressed to Steven Silverman, Director of the Office of Compliance, alleged false and misleading advertising of LASIK on the Robbins Eye Center website.

Attached to the letter was a 34-page “Consent Order” issued 11/22/2011 by the Connecticut Department of Health citing Robbins Eye Center for “wrong eye surgery, inadequate sanitation in the operating room, inadequate medical follow-up and monitoring after surgery, and questionable credentials of medical staff.”

Read letter with attached consent order

FDA Warns Against Illegal LASIK Ads Again

Reprinted with permission from www.fdaweb.com
09/28/2011
FDA Warns Against Illegal LASIK Ads — Again

Despite a 5/22/09 letter to eye care professionals cautioning against inappropriate advertising and promotion of FDA-approved lasers used in refractive procedures such as LASIK, FDA says it continues to receive information concerning improper promotion and advertising practices by eye care professionals. So it is writing to them again.

In a 9/23 letter, FDA says it wants to “emphasize the importance of providing adequate risk information in [your] advertising and promotion of FDA-approved lasers used in refractive procedures, and to advise these professionals where to get additional information, if needed.”

FDA says it expects that the notice and information about FDA resources on approved lasers and their associated risks will be sufficient to enable eye care professionals to correct within 90 days any ads or promotional materials that don’t comply with the Federal Food, Drug, and Cosmetic Act. “After that time,” it warns, “FDA may take regulatory action against eye care professionals whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions, and civil money penalty proceedings.”

The letter notes that it is critical that eye care professionals disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the device’s use. “FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health,” it concludes.

LASIK Patients Ask Hamburg’s Help on Petition

August 16, 2011
Reprinted with permission from www.fdaweb.com

LASIK Patients Ask Hamburg’s Help on Deferred Petition 08/16/2011

While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her to “carefully consider each signer’s remarks.”

Typical of such remarks were:

Eileen Newell, CA: “This issue is VERY important to me as I am one of the 20% of people with disastrous Lasik results. I have extremely dry eyes, starbursts, double vision, and severe depression. I can’t see my husband across from me at 12 feet or so. Can’t drive safely night or day. I am sick that I was misled regarding the chances of something like this happening.”

Vandana Gupta, India: “Because my life has changed forever. And because I have to start it afresh. And that is not easy.”

Robert Owen, United Kingdom: “Am now left with huge floaters constantly in my vision as a result of LASIK; a totally unnecessary practice.”

Janis Morrow, TX: “We came way too close to risk destroying our daughter’s eyes with this procedure. I pray they recall the lasik devices and outlaw the procedure.”

Zoltan Zeisky, PA: “I had LASIK, and I wish I could turn back the clock to undo my life altering MISTAKE!!”

Name not displayed, MO: “My brother has been practically blinded by LASIK surgery. He lives in chronic pain.”

Similar anecdotal testimony, although fewer in number, was given by injured LASIK patients at an April 25, 2008 meeting of the Ophthalmic Devices Panel of FDA’s Medical Devices Advisory Committee.

After hearing it all, panel chair Jayne Weiss, ophthalmology professor at Detroit’s Kresge Eye Institute faulted the industry for its “aggressive marketing” but wimped out by suggesting it was something for the Federal Trade Commission to look into. Subsequent efforts to interest that agency in LASIK vendors’ promotional violations produced nothing.

CDRH Disowns Statutory Authority Over LASIK Ads 01/31/2011

Reprinted with permission from www.fdaweb.com
2/1/2011

Twenty months after CDRH’s then director of compliance, Timothy Ulatowski, cautioned the nation’s eye care professionals not to make misleading or unsubstantiated claims in their advertisements about the effectiveness of lasers used in LASIK surgery, the Center has conducted no follow-up and last week announced it has no jurisdiction over LASIK ads.

“These lasers,” wrote Ulatowski back then, “are restricted medical devices that have been approved for particular uses and have risks associated with their use. Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.

“A restricted device is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 USC 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 USC 321(n)).”

Fast-forward 20 months to last Friday (1/28), when CDRH ombudsman David S. Buckles told LASIK victim and activist Paula Cofer: “I’ve investigated the matter you raised regarding the advertising practices cited in your message. Because the advertising practices apparently do not relate to medical products per se, but rather are advertising for the provision of services, we do not have jurisdiction in this matter. My understanding is that these issues are handled as ‘service industry claims’ by the Federal Trade Commission.”

Cofer, an FDA advisory panel patient representative, had sent CDRH compliance director Steven Silverman what she called a “blatantly deceptive” Web site link by Florida-based Brandon Eye Associates, and Silverman passed her off to Buckles, who has no enforcement authority.

In her request to Silverman, Cofer wrote that the Web site’s front page banner headline, “Kiss Your Contacts and Glasses Goodbye is misleading and deceptive. There is no disclaimer that some patients may need to continue wearing glasses or contact lenses, and there is no mention of risks, side effects, and contraindications.

“This is an example of the typical hype and failure to disclose risks that is prevalent in LASIK advertising on the Internet,” Cofer’s email to Silverman went on. “We, the injured LASIK patient community, have complained about this for years, but I have seen no change in the way LASIK is advertised. Former director of compliance, Timothy Ulatowski, sent a letter on 5/22/2009 to eye care professionals in what appeared to be a crack down on false and misleading LASIK ads. Since that time, it’s only gotten worse. There are thousands of LASIK ad violators on the Internet.

“As injured LASIK patients, what should we do when we see this type of illegal ad? Will anything be done by the FDA if we take the time to report them?

“I await a response.”

Another victim and activist, Dean Kantis, says he has sent CDRH “hundreds” of violative LASIK ads, to no effect. Has FDA investigated any of them, and if so, with what result? Buckles says “we are not in a position to disclose the status or even the existence of compliance and enforcement actions that are being contemplated or are in progress.”

Meanwhile, nearly 300 people have signed an online forum supporting a petition filed earlier this month by former CDRH ophthalmic devices director Morris Waxler, seeking an immediate ban on the procedure because of its unacceptable adverse events rate.

FDA did not respond to two requests for its input on this report.

LASIK Mystery Solved: FDA ‘Declassifies’ Secret Ads Policy

Reprinted with permission from www.fdaweb.com

02/01/2011

Direct from FDA’s “egg on our face” department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency’s jurisdiction/no jurisdiction over “restricted” device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted to reconcile a 20-month-old CDRH letter to eye care professionals asserting FDA jurisdiction over their LASIK ads with a 1/29 statement that FDA has no jurisdiction because the Federal Trade Commission has that jurisdiction.

Unstated in either letter was this new information, at the bottom of Riley’s seven-line delayed response to our request for clarification: “If statements in advertising and promotional materials do not relate to any of these restricted devices (or other FDA-regulated product), FDA generally defers oversight of such advertising and promotion to the FTC which has authority over unfair and deceptive business practices, including false advertisements related to products and services.”

If injured LASIK patients had known this 20 months ago, they could have sent all their LASIK ad complaints to FTC rather than to CDRH — which apparently ignored them.

Why LASIK is ‘Too Dangerous to be Allowed’ — German Firm

01/24/2011
Reprinted with permission from www.fdaweb.com

As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure. Adding to data in a petition for an immediate ban from former CDRH LASIK review chief Morris Waxler, the company says it has developed a unique device that measures the topography of the eye during refractive laser treatment and its research has shown “that LASIK in general is too dangerous to be allowed,” according to co-founder Daniel Kluting in an email to FDA Webview.

“The problem is that the LASIK cut brings problems to the structure of the eyes,” Kluting writes. “Because we have the only measuring device that is able to measure the topometry of the eyes with resolution of a few microns, we can look deeper into microeffects than anybody else. One of the major questions in research is, what is the cornea built of? From our research it seems to be that it consists of tissue layers with a tensive strain to all sides. Think about cutting in something like that!”

The permanence of the never-healing corneal flap cut is a major concern in Waxler’s petition, which last week was still deep in a queue in the Commissioner’s Office, awaiting a decision on whether or not to even accept it for consideration. In less than a year, Waxler has hardened his position from tolerating LASIK’s continuation to petitioning the agency for a complete ban and vowing to seek FDA Office of Criminal Investigations focus on laser makers who allegedly hid LASIK safety issues.

Moreover, it has been 16 silent months since former CDRH compliance director Tim Ulatowski launched a mini-blizzard of Warning Letters to LASIK ambulatory surgical facilities over their failure to file MDR reports and peppered the industry with advice to include risk information in their ads — with no further word from him or his successor, Steve Silverman, about agency follow-through, if any.

During the ensuing inactivity, injured LASIK victim and activist Dean Kantis says he has sent the agency “hundreds” of violative LASIK ads “that do not list all known risks and side effects … And the FDA continues to do NOTHING to discipline them. Why is it when I turn on the TV, every prescription drug commercial has 30 seconds of warnings yet when it comes to elective LASIK ads on TV or radio, there isn’t one word mentioned of the warnings?”

FDA’s ingrained unresponsiveness on the LASIK safety issue may be well illustrated by its failure to respond to a cogent 9/13/09, heavily documented 14-page letter from LASIK Surgery Watch to CDRH director Jeff Shuren describing the risks of the procedure and contending that “FDA has been grossly negligent and has placed patients’ interests secondary to interests of surgeons and medical device manufacturers.” The organization said 1/23 that none of its letters to the agency had brought responses.

Kluting’s email says that “from our point of view we would like to see LASIK stopped immediately. Then the laser manufacturers need to do some basic research on eyes [to] probably come up with a completely new way how to do refractive surgery. During the last 7 years the laser industry knew the problems, but did not want to go through the process of basic research combined with the [stopping] of LASIK. Right now with LASIK the cornea is damaged, the only good thing is that the cornea excuses a lot and the eye is still able to see. Nearly all risks of LASIK are because the procedure is not safe. It’s not because of the patient or a misfortune.

“We have just a measuring device. Our goal was to measure the ablation during refractive surgery to avoid using nomograms and be more precise. We did clinical trials with one of the large players on the market. But we found out that first all surgeons and the industry need to understand the eye better. We have a couple of ideas how refractive surgery can be in the future, but till now … laser manufacturers avoid … [talking] with us. Even those we made the clinical trials with, 8 years ago. It’s easier to leave the moneymaking machine LASIK turned on than to go through the struggle of development.

“So we went into the market of scleral lenses and wait for the refractive market to wake up. All patients who got hurt by LASIK since mid-2005 could have been prevented.”

BioShape’s new report next week is expected to update and supersede its 2005 report on the same subject, Complications of Refractive Laser Surgery.

In a comment to FDA Webview, former FDA medical device compliance director Larry R. Pilot, who has been deeply involved in the LASIK issue with injured patients, called FDA’s management of its regulatory program for LASIK “a clear dereliction of duty and responsibility to the concept of ‘protection of the public health’.

While there may be valid applications for LASIK eye surgery,” Pilot continued, “the vast majority of uses involve risks to the patient/customer that are often unknown until after the fact. The FDA/CDRH has failed incredibly to monitor post market experience through its mandatory MDR program. For just this program alone, the potential for patient protection was there for years, yet the CDRH deliberately ignored the responsibility to inspect or review the performance of any of the possible thousands of user facilities which were in absolute violation of law and regulation.

“Current and past FDA/CDRH employees shared this liability and should have been/should be punished for their failures. … I agree that the optimal approach to reporting is to have the FDA/CDRH enforce the MDR requirement applicable to user facilities. From the outset of my involvement with this LASIK issue, I have repeatedly emphasized this fact. It took two years for the FDA to display some movement, but more is needed.”

Asked to comment on this story, FDA press officer Karen Riley replied: “We cannot comment on the specifics of the German report, as we have not received or reviewed it. As you well know, FDA continues to monitor the safety and effectiveness of all devices, including the lasers approved for LASIK. In October of last year we provided a brief update on our role in a three-part study of LASIK that is still in the beginning phases. It is a project that we hope will yield additional insights about this procedure. Stay tuned.”

FDAer Who OK’d LASIK Petitions for Revocation

Reprinted with permission from www.fdaweb.com
01/06/2011

Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who has publicly said the agency “screwed up” when it approved LASIK vision enhancement lasers on his watch in 1997, petitioned the agency 1/6 to undo that mistake by “withdraw[ing] FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery.” CDRH is currently awaiting the results of a U.S. Navy LASIK quality-of-life study it commissioned in 2009 that is expected to report at the end of 2012.

In his extensively documented petition, Waxler says the approval was based on data that were “dominated by LASIK surgeons working hand-in-glove with LASIK manufacturers. Data recently brought to light exposes this partnership for what it was: a classic example of the fox guarding the henhouse, wherein the primary arbiters of safety and effectiveness of LASIK devices were the device manufacturers and its collaborators.

“Surgeons used LASIK devices in violation of required manufacturing quality controls (21 CFR 820), patient protections (including but not limited to 21 CFR 50; 54; 56; and 812), and reports of adverse events (including but not limited to 21 CFR 803; 812; and 820) when they manufactured and distributed LASIK devices in interstate commerce within the United States as:

• Homemade lasers (‘black boxes’)
• Imported investigational lasers (‘grey boxes’)
• Illegal key cards (“Bermuda cards”) and
• ‘Off-label’ photorefractive keratectomy (PRK) lasers

“As a consequence,” Waxler’s petition continues, “the FDA was deprived of knowledge of the full extent of LASIK injuries prior to and during FDA reviews of documents submitted in support of the safety and effectiveness of LASIK devices under 21 CFR 812 and 21 CFR 814.

“In addition, LASIK manufacturers and their collaborators withheld safety and effectiveness information from their investigational device exemption (IDE) reports to the FDA. In addition, they hid LASIK injuries from FDA within the context of out-of-court settlement of innumerable lawsuits. Clinic-sponsored IDE studies cherry-picked, withheld, and hid data from FDA that clearly showed LASIK with excessive adverse event rates (greater than 1%). These activities were an industry-wide effort, organized wholly or in part by the manufacturers and their collaborators in order to circumvent FDA law and regulation. I will submit CONFIDENTIAL information on these matters separately to FDA’s Office of Criminal Investigation.”

Waxler petition says that contrary to FDA’s own device approval standard limiting adverse events to 1%, published scientific data show that LASIK devices induce an average adverse event rate of about 22% “that persists beyond six months to five or more years.”

Moreover, he says, the published data shows that LASIK devices transform healthy corneas into sick corneas that never completely heal; are permanently weakened, vulnerable to trauma and inflammation; cause neuropathic dry eyes, have pathology that progresses annually; are vulnerable to blinding corneal bulging (keratectasia); compromise night vision; have unstable vision corrections that regress; and require eye care that otherwise would not be needed.

“FDA originally counted glare, halos, dry eye, night driving difficulties, and similar problems after excimer laser refractive surgery as adverse events,” Waxler’s petition says, citing the FDA-approved Patient Information Brochure where it says “…adverse events beyond the first few months: night vision difficulty (48.1% at six months)…glare (34.4% at 6 months)…”

Waxler says LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than 1%. “The true adverse event rate six months or more post-LASIK is at least 20 times the FDA approvable rate of 1%,” he says.

Waxler’s petition includes a table showing, he says, that “manufacturers knew that about 43% of LASIK patients’ visual acuity could be improved by wearing spectacles 6-12 months after surgery. The manufacturers and their collaborators distorted this evidence.”

Is the Assault on LASIK ‘Critics’ Justified?

11/23/2010

An article titled “Is the Assault on LASIK Justified?” appears in the November, 2010 issue of Cataract & Refractive Surgery Today.

This article is essentially an “assault” on Morris Waxler, PhD, former head of the FDA branch responsible for reviewing the original LASIK clinical trials. In typical LASIK industry fashion, the article’s contributors attempt to discredit Waxler professionally because he exposed LASIK risks. But it doesn’t stop there. The article is also a personal attack, filled with insults and false accusations against Waxler.

Waxler went public in 2009 regarding his concerns about LASIK eye surgery after taking a second look at data from LASIK clinical trials, and also examining recent data published in peer-reviewed medical journals. Waxler communicated with a number of injured LASIK patients in an effort to understand their complaints, and he found a disconnect between LASIK surgeons’ definition of a success and patients’ experiences. Waxler now feels that problems such as persistent dry eyes, starbursts (“glare”), halos, and night driving problems, which may have a profound negative impact on patients’ quality of life, should have been counted as “adverse events” rather than dismissed as mere “symptoms” by the FDA. Importantly, Waxler found that incidence of these problems reported by patients in clinical trials is unacceptably high, even with the latest LASIK technology.

Furthermore, Waxler has serious concerns about late onset complications and long-term risks, which were not detected in clinical trials with short-term follow-up. Specifically, the FDA did not consider delayed post-LASIK corneal ectasia and problems related to the fact that the corneal flap heals only minimally, leaving the cornea fragile and weak for the patient’s entire lifetime. Waxler now believes the FDA made a mistake in approving LASIK devices in an environment of enormous pressure from prominent ophthalmologists who worked hand-in-glove with FDA reviewers.

Injured LASIK patients believe that there has been industry-wide cover-up of LASIK problems from the beginning, and that financially-motivated investigators corrupted LASIK clinical trials by submitting massaged and falsified data and withholding negative data. They also believe that LASIK surgeons will stop at nothing to protect their cash cow.

The LASIK industry and its representatives have a long history of attacking groups and individuals who speak out about hidden risks and long-term consequences of LASIK. Many vocal critics of LASIK have become victims of cyber-bullying, intimidation, threats directed at themselves and their family members, harassment, defamation, interference with employment, frivolous lawsuits, SLAPP lawsuits, and even criminal acts.

Public outcry of widespread problems with LASIK, such as intractable dry eye and night vision problems, led to a showdown between injured LASIK patients and LASIK industry representatives at an FDA hearing in April, 2008. Several cases of LASIK-related suicide and suicidal depression were discussed during the open public hearing. Just weeks prior to the FDA hearing, a North Carolina newspaper reported, “Scientists at the Emory Eye Center in Atlanta reviewed suicides among organ donors who had had laser eye surgery. Preliminary results suggested the suicide rate might be four times as high among cornea donors who had had LASIK as among cornea donors who had not.” Richard Lindstrom, MD, then-president of the American Society of Cataract and Refractive Surgery (ASCRS), a professional organization of LASIK surgeons, was quick to criticize the newspaper in a letter to the editor, characterizing the story as irresponsible reporting and a “disservice to the millions of Americans who elect to undergo vision correction surgery each year.”

At the same FDA hearing, Diana Zuckerman, PhD, of the National Research Center for Women & Families reported that she had contacted Emory in an unsuccessful attempt to obtain more information about the organ donor study, which has not been published. Injured LASIK patients believe LASIK surgeons suppressed the data.

Several months later at the 2009 ASCRS annual meeting, LASIK surgeons performed comedy skits mocking injured and suicidal LASIK patients.

In a surprising turn of events, the FDA began inspecting LASIK clinics and issued warning letters in 2009 for failure to report LASIK complications as required by federal law. LASIK critics say this move was long overdue, as they have complained to the FDA for years that the LASIK industry was hiding LASIK problems.

LASIK critics have nothing to gain by speaking up, and they face backlash and retaliation by the LASIK industry. On the other hand, LASIK surgeons have plenty to lose financially if the public learns the truth about this risky, unnecessary surgery.

LASIK surgeons are crying foul over what they perceive as an “assault on LASIK”. Perhaps LASIK surgeons are concerned about loss of income and potential class action lawsuits which may result from closer scrutiny of the LASIK procedure.

Mounting Frustration Over Delays and Bias in FDA Study of LASIK

Opinion Editorial
10/20/2010

On 10/19/2010, the FDA issued a press release to update the public on the LASIK Quality of Life Study, which has been on hold for nearly three years.

After years of public outcry of widespread, long-term problems with the LASIK procedure and reports of LASIK-related depression and suicide, the FDA announced in 2008 that it would reevaluate LASIK safety. The FDA reported that it had partnered with organized ophthalmology — American Society of Cataract and Refractive Surgery (ASCRS) and American Academy of Ophthalmology (AAO) — to conduct a post-LASIK quality of life study. LASIK patient advocates were extremely critical of organized ophthalmology’s involvement in this proposed study, comparing it to “foxes in charge of the hen house”.

In response to negative press surrounding an FDA hearing on LASIK safety, organized ophthalmology launched a media campaign defending the procedure. LASIK surgeons, supported by ASCRS, published a literature review1 of reported ‘LASIK satisfaction’, but withheld the associated high complication rates from the publication.

About the same time, LASIK patient advocates learned that prominent ophthalmologists who attended an ASCRS convention had performed ‘comedy’ skits mocking damaged and suicidal LASIK patients. FDA blogger, Jim Dickinson, sent an email to ASCRS’ Director of Communications, John Ciccone, requesting confirmation that the skits were presented at ASCRS’ annual meeting. Ciccone confirmed that the skits were, in fact, presented at the meeting; however, he expressed regret over the matter.

Months went by with no word from the FDA on the proposed study. LASIK patient advocates accused the FDA of stalling while hundreds of reports of LASIK-related adverse events poured in to the agency. Apparently, the FDA had quietly scrapped plans for involving organized ophthalmology in the proposed study.

Meanwhile, former FDA chief of ophthalmic devices, Morris Waxler, PhD, came forward to speak out publicly against LASIK eye surgery. In the 1990’s, Waxler had been in charge of reviewing the original LASIK clinical trials, and played a key role in its approval. Waxler now believes that the agency was wrong to approve LASIK devices. He says that the FDA lacked in-house expertise to assess the significance of long-term adverse effects, such as dry eyes and night vision problems. These problems were reported by a large number of patients after LASIK. In hindsight, Waxler feels these issues should have been taken more seriously. Waxler says that very renowned ophthalmologists pressured the agency to approve LASIK. Since the original approval, other very serious, delayed complications have emerged such as corneal ectasia, which often requires corneal transplant.

In October 2009, the FDA issued a second press release announcing plans for a LASIK Quality of Life Project and simultaneously announced the issuance of warning letters to a number of LASIK facilities for failure to report LASIK adverse events. This time, the proposed study was to be a collaboration with the U.S. Department of Defense involving an active duty population treated at the Naval Medical Center San Diego (NMCSD).

LASIK patient advocates expressed strong concern of bias on the part of military LASIK surgeons, particularly Navy LASIK surgeons, who have close ties with organized ophthalmology. For example, Steve Schallhorn, MD, Capt, US Navy (Retired) is a paid medical malpractice defense expert witness and an industry consultant, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, has financial interests in companies that manufacture LASIK devices, and is currently medical director of one of the largest corporate providers of LASIK in the world. An article in the December, 2009 edition of JAMA2 reported that Schallhorn is “confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective”. Furthermore, LASIK patient advocates have questioned a defense contract awarded around the time of Schallhorn’s retirement from the Navy. In December 2006, IntraLase announced that the Dept. of Defense had awarded the company a $45 million, 5-year contract to supply its flap-cutting lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies. Shortly thereafter, it was reported that Schallhorn was a consultant for and had financial interests in Advanced Medical Optics, the company that acquired IntraLase.

Another Navy LASIK surgeon, Capt. David Tanzer, MD, is a member of AAO and ASCRS, and co-authored several papers favorable to LASIK with Schallhorn. Tanzer is the current Director of Refractive Surgery at Naval Medical Center San Diego, and has a private practice at one of the country’s largest LASIK chains, TLC Laser Eye Centers.

In spite of mounting criticisms of FDA’s decision to collaborate with the Department of Defense in a study of post-LASIK quality of life, the agency has now placed Bradley S. Cunningham, formerly of Walter Reed Army Institute of Research, over the division that regulates LASIK lasers. LASIK patient advocates feel that by replacing ASCRS with the Department of Defense, FDA has simply traded one embarrassing collaborator with conflicts of interest for another.

The 10/19/2010 FDA press release states that the clinical study will begin within the next three months at Naval Medical Center San Diego. However, the protocol has not been disclosed. On 9/27/2010, Jim Dickinson requested more information under the Freedom of Information Act, but the agency has been unresponsive so far.

In the meantime, LASIK patient advocates continue to wait, hoping for some action on the part of the FDA to quell the growing number of patients injured by a lucrative surgery that serves no medical need. Unfortunately, it appears that the only thing slowing LASIK down is the economy.

References:

1. Solomon KD, Fernández de Castro LE, Sandoval HP, Biber JM, Groat B, Neff KD, Ying MS, French JW, Donnenfeld ED, Lindstrom RL; Joint LASIK Study Task Force. LASIK world literature review: quality of life and patient satisfaction. Ophthalmology. 2009 Apr;116(4):691-701.

2. Mike Mitka. FDA Focuses on Quality-of-Life Issues for Patients Following LASIK Surgery. JAMA. 2009;302(22):2420-2422.