Gaithersburg, MD
April 25, 2008
FDA HEARING PRESENTATION OF LAURANELL H. BURCH
I appreciate the opportunity to speak at this FDA hearing on post-market LASIK issues. My name is Lauranell Burch. I have a Ph.D. in Molecular Biology and Genetics and have been a medical researcher for over 20 years. I am trained to design, conduct, and review medical research studies.
We are all aware of recent media attempts by the LASIK industry to reframe the discussion of these hearings around post-LASIK satisfaction and quality of life issues. The public should be made aware that the proposed task force to examine post-LASIK quality of life issues is dominated by individuals who have conflicts of interest. One of these individuals, Dr. Kerry Solomon, was quoted this week by ABC news regarding this meeting saying: “This is not about safety and effectiveness of LASIK surgery at all,”… If there were no serious concerns about the safety and effectiveness of LASIK - we wouldn’t be here today. What is most important for us all to consider now is the growing body of evidence accumulating in peer-reviewed Ophthalmology journals that indicate that LASIK is a harmful procedure.
Despite claims made by surgeons and the industry about ‘patient satisfaction’, today’s happy 20/20 LASIK patients are often today’s dangerous drivers on our highways at night due to LASIK-induced loss of contrast sensitivity, and may ultimately experience debilitating late-onset complications of LASIK.
Patients who report that they are currently happy with the LASIK procedure likely have no idea of the nature and extent of damage they incurred during the LASIK procedure and the consequences of this damage for their future ocular health and vision. I believe that no patient would want this surgery if they fully understood its consequences.
Here is a short list of permanent adverse effects of LASIK eye surgery:
1. The flap never heals – it just seals a bit around the edges like a Tupperware lid leaving patients who have had LASIK susceptible to traumatic flap injury for life.
2. LASIK separates the stronger anterior cornea, leaving only the weaker posterior cornea to support the intraocular pressure of the eye. This can lead to corneal ectasia and corneal failure months or years after surgery.
3. LASIK causes permanent pathological changes in all corneas. According to an Emory University study that examined post-mortem LASIK corneas, “A spectrum of abnormal histopathologic and ultrastructural findings was present in all corneas.” Some examples include deranged and disorded collagen fibers, granules under the flap, and epithelial ingrowth under the flap.
4. There is no evidence that corneal nerves ever fully regenerate to their normal patterns and density after LASIK.
5. LASIK complicates future cataract surgery.
6. LASIK invalidates intraocular pressure measurement, which is critical in the diagnosis of glaucoma.
7. Perhaps the gravest of all adverse effects of LASIK was reported recently by Mayo clinic researchers in a study which indicates that patients undergoing laser corneal refractive surgeries lose keratocyte (or corneal stromal cell) density at higher rates even years after surgery. Apparently, excimer laser ablation of corneal stroma results in progressive cell loss in the cornea.
In the peer discussion following this study, LASIK surgeon Dr. Roger F. Steinert commented, and I quote him: “One can speculate that this loss might lead to corneal ectasia.”
Clearly, patient satisfaction surveys are no substitute for objective quantitative testing, particularly when the technology for performing objective tests is widely available.
I ask that the FDA abandon the proposed quality of life study in favor of a study which objectively and quantitatively measures aspects of post-LASIK dry eye disease and post-LASIK visual quality. These studies can be performed on existing patient populations with unoperated eyes as controls. Withdrawal of FDA approval for the LASIK procedure should take place immediately pending the outcome of these studies. Only then will the FDA be able to achieve evidence-based policy about corneal refractive surgery devices, and only then will the public receive the benefits of evidence-based medicine.
July 2nd, 2008
May 19, 2008
Dockets Management Branch
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville, MD 20852
Citizen Petition
The undersigned submits this petition to:
1) ban the use of all refractive surgery lasers for LASIK surgery due to substantial deception in the labeling and an unreasonable and substantial risk of injury, and
2) acknowledge and enforce remedy for the misbranding of lasers used for LASIK (false and misleading labeling) due to failure to properly report adverse events and complications.
The authority for the first action is under U.S. Code Title 21, Section 516 [21 USC 360f] of the Federal Food, Drug, and Cosmetic Act, Banned Devices. Authority for the second action is under U.S. Code Title 21, Section 502 [21 USC 352a] of the Federal Food, Drug, and Cosmetic Act, Misbranded drugs and devices - False or misleading label.
Factual Grounds
In the FDA clinical trials of lasers for LASIK, the devices failed to meet the Agency’s safety requirements. The guidance document dated 9/5/1997 titled Discussion Points for Expansion of the “Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers” Draft Document (exhibit A) states that less than one percent of eyes may experience adverse events. A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved from 1998 through 2004 (exhibit B) found that six months after LASIK, 17.5% of patients report halos, 19.7% report glare, 19.3% report night-driving problems and 21% report dry eyes. These complications were deceptively reported as “symptoms”; however, they should have been reported as adverse events. The risk of injury from the medical devices used to perform LASIK is unreasonable and substantial. The purported benefits of LASIK (reduced dependence on glasses or contact lenses) do not outweigh the risks. LASIK surgery does not meet any medical need that cannot be met with safer alternatives, such as glasses or contact lenses.
LASIK devices appear to meet the efficacy standards for approval; and most patients report satisfaction with the visual outcome even in the presence of complications such as dry eyes and night vision impairment. It should be noted, however, that of the 14 FDA approvals for LASIK, no study of safety and effectiveness of LASIK reported adverse events in less than one percent of eyes as required by FDA safety requirements for approval.
Environmental Impact
This petition qualifies for categorical exclusion under 25.30 - 34 of this chapter from the requirement of an environmental impact assessment.
Certification
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner, which are unfavorable to the petition.
______________________________
Name of petitioner: Lauranell H. Burch
Exhibit A: Checklist of information usually submitted in an Investigational Device Exemption (IDE) application for refractive surgery lasers.
Exhibit B: Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54.
July 2nd, 2008
Reports of LASIK complications to the FDA’s MedWatch program (MAUDE Database) for medical device adverse events have nearly doubled since the public announcement of the the April 25th, 2008 Special Hearing of the Ophthalmic Devices Panel, held to discuss post-LASIK quality of life, depression, and suicide. At the hearing, two medical doctors, two optometrists, three psychologists, and a number of injured patients presented compelling information establishing a causal link between bad LASIK, depression, and suicide. Excerpts from two suicide notes were presented, including that of a medical student (video: http://www.youtube.com/watch?v=UX855jmViaM) and that of a police officer who was well respected in his community (video: http://www.youtube.com/watch?v=PBAqnVfJ5GU).
Over the past decade since LASIK was FDA-approved, the Agency has failed to enforce physician reporting of adverse events. In March and April, 2008, patients were made aware of the voluntary reporting option by media reports of an upcoming FDA Special Hearing on LASIK problems.
The recent, rapid growth of complaints in the MAUDE database is, presumably, particularly embarassing for the American Society of Cataract and Refractive Surgery (ASCRS). In its April 7th, 2008 press release, ASCRS attempted to spin public perception of the Special Hearing by stating that “Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients.” Unfortunately for ASCRS, nearly twice as many complaints have been received in the last six months as in the last ten years since LASIK’s approval.
The growth of complaints is also embarassing for the FDA, since some patients at the meeting charged that they are victims of an ongoing medical coverup, perpetrated by collusion between ASCRS and the FDA. Indeed, in its April 7th, 2008 press release, ASCRS stated that “The FDA reaffirms that LASIK is both safe and effective.” LASIK critics have responded to this assertion by asking publicly “When exactly was ASCRS authorized to make public announcements for the Food and Drug Administration?”
Three other sources of information suggest collusion between ASCRS and FDA. First, prior to the Special Hearing, patients who came to the FDA’s website were encouraged to use a comment form to report their vision issues and dry eye complaints to the FDA. Unknown to patients, these complaints were held by FDA Center for Devices and Radiological Health (CDRH), but were never registered in the MAUDE reporting system. Neither were they reported in the April 7th ASCRS press release. Why did the FDA CDRH choose to suppress these complaints? Was it to make LASIK look safer than it really is? Even though LASIK surgeons are required to report adverse events from LASIK to the FDA, most surgeons have apparently never filed a single MedWatch report, despite the fact that ASCRS admits that up to 5% of patients are dissatisfied with their results.
Second, compare the ASCRS press release with a 2006 document issued by the FDA CDRH at http://www.fda.gov/cdrh/postmarket/mdpi-report-1106.html. In this document, CDRH states frankly that “The data that are submitted via MDR rely upon a generation-old software platform (MAUDE) to organize, store and allow management of the data. This software, due to its age and limitations, does not allow MDR to serve its customers well. FDA staff and stakeholders report that MDR…does not provide timely and usable data to staff or other system users…[and]…has a large backlog of reports which hampers the ability to detect signals or identify problems.” Obviously, this document establishes that the FDA has long been aware of deficiencies in the MAUDE reporting system. Why, then, did the FDA allow ASCRS to speak for the agency? Why was ASCRS allowed to publicize deficient and inaccurate information in order spin public perception about the safety of LASIK? If the MAUDE system was known to be broken, why were complaints issued to the agency through its LASIK comment form never counted?
Third, according to an article in the June 2008 issue of Cataract & Refractive Surgery Today, in November 2006, the same month the FDA released criticism of its MAUDE reporting system, the FDA approached ASCRS and American Academy of Ophthalmology (AAO) to form a Joint LASIK Study Task Force in response to complaints sent to the FDA and Congress by damaged LASIK patients. Apparently, ASCRS surgeons had over 1.5 years notice of FDA’s intention to call a Special Hearing for LASIK post-market issues. In contrast, medical doctors, optometrists, psychologists, and injured patients who spoke on behalf of thousands of LASIK victims were not aware of the planned hearing until it was publicly announced in the Federal Register at the end of March, 2008. These individuals had just one month to prepare. Why did the FDA give the LASIK industry 1.5 years notice of the Special Hearing while patient groups and the public had only a one month notice?
Patient advocates want answers to these questions. So do thousands of damaged LASIK patients.
June 16th, 2008
Amid bad publicity for the LASIK industry, a group of LASIK surgeons announced preliminary findings from an unpublished review of medical studies showing a “95.4% global LASIK satisfaction rate”.
Press releases issued by LASIK industry insiders appeared to link this literature review to the FDA with misleading statements such as, “The FDA reaffirms that LASIK is both safe and effective.” When asked for clarification about the link between the study and the FDA, LASIK surgeon Kerry Solomon admitted that the study was performed independently from the FDA.
Clearly, this literature review was the LASIK industry’s attempt to reframe the discussion of last month’s FDA hearing concerning problems with LASIK. The review has not been published, but surgeons involved in the study report that 19 studies (2,199 patients) were selected from the thousands of LASIK studies in the body of peer-reviewed literature for the meta-analysis. This represents only .013% of patients who have had LASIK world-wide.
Interestingly, many more published medical studies show large percentages of patients experience complications after LASIK, even when the visual outcome is considered satisfactory.
Similarly, a published review of data for the twelve lasers approved by the FDA for LASIK between 1998 and 2004, including current technology, shows that six months after LASIK, 17.5 percent of patients report halos, 19.7 percent report glare (starbursts), 19.3 percent have night-driving problems and 21 percent complain of eye dryness. Based on these data, the lasers failed to meet the FDA’s safety requirements for approval.
Not only did the FDA approve unsafe devices for LASIK, the Agency also failed to enforce reporting of adverse events. When a patient experiences a bad outcome from LASIK, the physician should notify the FDA by filing a MedWatch report. The medical literature contains hundreds of case reports of serious complications after LASIK, and thousands of medical studies of LASIK showing frequently occuring complications, yet the FDA recently announced that only 140 reports of adverse events after LASIK have been reported through MedWatch in the past decade. Apparently, most LASIK surgeons have never filed a single MedWatch report, even though all LASIK surgeons have patients with complications. And patients are not informed that they may voluntarily file their own MedWatch report. Clearly, adverse events from LASIK have been grossly underreported, and LASIK surgeons are not held accountable. In response to complaints from patient advocates, the FDA added a link to file a MedWatch report on its LASIK website in late May, 2008.
May 31st, 2008
May 10, 2008
Daniel Schultz, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Dear Dr. Schultz:
I was initially encouraged to see the FDA take action by convening an advisory panel on April 25, 2008 to conduct a hearing on LASIK post-market issues including the impact on a patients’ quality of life (QOL). However, I attended the hearing and found the lack of panel discussion regarding post-LASIK quality of life (QOL) issues to be disappointing. It was stated publicly before the hearing that QOL would be on the panel members’ agenda and there were several accounts from open public hearing speakers who had interacted with hundreds of patients with severe depression and suicidal ideation post-LASIK. Yet there was no discussion amongst the panel members regarding post-LASIK QOL issues.
The open public hearing speakers who discussed the potentially severe emotional toll related to post-LASIK visual disturbances and severe dry eyes included a clinical psychologist, a medical doctor, an optometrist, a father whose son took his own life and left a note detailing his emotional struggles due to his sight having been ruined by LASIK, a wife whose husband took his life last month in Tennessee and left a note stating that his post-LASIK visual disturbances and severe dry eyes were the cause, a wife of a patient who discussed two additional LASIK related suicides, and two patient advocates who have formed support groups for post-LASIK complication patients. Most of the emotional toll from LASIK adverse events was caused by night vision disturbances, loss of best correctable vision and severe chronic dry eyes.
While the FDA has announced plans to study QOL issues related to LASIK, I am concerned that the proposed study will be biased. The FDA and National Eye Institute (NEI) have announced an unprecedented partnership with industry. The American Society of Cataract and Refractive Surgeons (ASCRS) and the American Academy of Ophthalmology (AAO) plan to conduct a post-LASIK QOL study to commence by 2009. ASCRS has announced the names of three LASIK surgeons who will design and conduct the study. These doctors have obvious financial conflicts of interest. Also, Drs. Lindstrom and Schallhorn have publicly stated that there is no correlation between depression and post-LASIK adverse events such as visual disturbances and severe dry eyes, and therefore cannot be expected to conduct unbiased research on this issue.
I recommend the following actions be taken to protect and inform the public that the FDA is entrusted to protect.
1. Halos, glare, night-driving problems and chronic dry eyes should be reported as adverse events and not symptoms by the FDA. Mary Weick-Brady of the FDA’s Center for Devices and Radiological Health stated the following in a National Public Radio (NPR) interview aired on May 1st, 2008; “If it’s a decrease in vision, if it’s a halo, if it’s a starburst, if it’s a problem with night vision, these types of things would be considered adverse events to FDA, and we would want those reported because it has affected your vision”. In addition, at the FDA hearing on April 25th, 2008, Malvina Eydelman, MD, head of the FDA’s division of ophthalmic devices, also stated that it was her understanding that halos, glare, and night-driving problems were listed as adverse events. The statements made by the FDA are consistent and logical when describing these complications as adverse events since they can be permanent and life altering. Therefore, I anticipate that the FDA will officially accept that LASIK induced halos, glare, night-driving problems and chronic dry eyes are indeed adverse events.
2. The FDA has partnered with ASCRS LASIK surgeons who have financial conflicts of interest in the procedure. I request that any ASCRS member with financial interests in LASIK device makers be rejected by the FDA. It is imperative that proper FDA monitoring and oversight controls be put in place to avoid LASIK surgeon-biased outcomes. I also feel that Drs. Lindstrom and Schallhorn particularly should be excluded from such studies, as they have publicly expressed their belief that there is no correlation between depression and post-LASIK adverse events such as visual disturbances and severe dry eyes. These statements have been made despite the fact that two post-LASIK suicides have occurred within the last year where patients have left suicide notes stating that they could no longer live with their post-LASIK vision disturbances and severe dry eyes.
3. The FDA should advise prospective LASIK patients that clinical depression can result secondary to LASIK complications including post-LASIK visual disturbances and severe dry eyes. In order to meet this recommendation, clinical depression should be listed as a potential side effect of LASIK in the labeling and on the FDA website.
In the interest of informing the public of the risks of LASIK, I look forward to seeing the FDA adopt the changes recommended at its upcoming meeting.
Sincerely,
Matt Kotsovolos
May 12th, 2008
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