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This letter addresses my concern about the safety of LASIK surgery. I have practiced ophthalmology for thirty-three years. After taking all the courses on LASIK, I decided not to do the surgery. I believe LASIK surgery is not consistent with the ophthalmologist’s hypocritic oath of “first do no harm. ” Statistics on complications could easily be manipulated by surgeons and I don’t think their reporting of complications can be relied upon. I think a few points are more valid: it was reported in the last year in the literature that LASIK surgeons have an income creating the setting for significant bias. A highly significant fact that seems to be passed over without much comment is that the LASIK flap can be easily lifted for up to at least ten years exposing the pt to the risk of dislocating and/or losing the flap when subjected to injury. A recent article told of four such cases after ten yrs. When I have explained this fact to hundreds of patients who were considering LASIK, everyone stated that it is enough reason not to do the surgery. I explained to them that it’s as if you had a circular patch of skin incised and replaced and it could be easily lifted up ten years later. Everyone is overwhelmed with this fact and say they are convinced that they won’t do the surgery. When I have seen patients that have had LASIK surgery with other doctors, none of them were aware of this fact. We are playing Russian roulette with these patients, hoping statistically that they won’t be hit in the eye. We are also playing this Roulette game hoping beyond all hope that they don’t get infection, but we all know infections happen. I went to a meeting at the last conference in 2007 which was concerned with how commonly senior citizens eyes become irritated from dryness and the use of multiple preservatives over the years. I asked the panel at the meeting, many of whom are LASIK surgeons, why aren’t we more concerned about the damaging effects of LASIK which causes dry eye and damaged corneal nerves. They elected not to answer the question. I think we have a panel already in this country that is ideal to give you the answer to the problems with LASIK. The panel consists of the thousands of ophthalmologists who chose not to do this procedure knowing they could make a half million dollars more per year. I think you should send a questionnaire out to all the ophthalmologists, especially those who don’t do this surgery and ask them why they don’t do it. I have seen other examples of where the FDA allows higher risk manipulations of the eyes when it clearly is against the patients’ interest. Two of these examples are allowing all-in-one chemical solutions for contact lenses without advising the patient to rinse off the detergent and disinfectant with saline. These patients are soaking their eye all day in these two irritating chemicals. The three most commonly used solutions do not recommend rinsing. Another pandering to patients is the following of no-stitch cataract surgery, even though Medicare has shown the doubling of the incidence of infection in the eyes in the last ten years since no-stitch surgery has been initiated. This is not likely a coincidence. The three examples cited in the letter, i. e. , LASIK surgery, all -in-one contact lens solutions, and no-stitch cataract surgery are all examples of pandering to patients vulnerable instincts in an effort to promote a “wow” factor, rather than a healthier outcome. I have seen over the last thirty-five years in ophthalmology a steady trend within the profit side of medicine taking precedence over “first do not harm”.
Source: FDA Maude Database Report
August 9th, 2008
MIAMI, FLORIDA — A new study published in the July, 2008 edition of Archives of Ophthalmology demonstrates an elevated risk of suicide in people with visual impairment.
The psychosocial and health consequences of ocular conditions that lead to visual impairment (VI) are broad and include impaired activities of daily living, social isolation, cognitive impairment, impaired functional status and functional decline, increased dependency on others, increased risk of motor vehicle crashes, falls and fractures, poor self-rated health, and depression. Increased mortality risks also have been noted in adults with VI and disabling eye disease… Up to two-thirds of people who commit suicide have some type of physician contact in their last month, and physician education is effective in reducing suicide rates. Our results suggest older adults and those with nonocular health conditions, poor self-rated health, and reported VI are at increased suicide risk. Eye care professionals should be aware of the potential increased risk of suicide for patients with VI, especially those in poor health, and provide appropriate referrals for these patients… In summary, we observed that reported VI increased suicide risk, particularly indirectly via reported health status and health conditions.
Earlier this year in response to media reports of depression and suicide following LASIK, LASIK industry insiders denied any connection.
Dr. Richard Lindstrom, “The premise of your Feb. 3 article ‘Some link depression, failed LASIK’ was based upon incomplete, unpublished and anecdotal research and did a disservice to the millions of Americans who elect to undergo vision correction surgery each year. It is irresponsible to draw a conclusion between LASIK and suicide. There is simply no scientific basis to support a direct connection between a sub-optimal outcome from eye surgery and suicide.” Source
Dr. Steven C. Schallhorn, “There’s no cause and effect.” Source
These statements by LASIK industry leaders are perplexing, given the contradictory evidence published in the body of scientific literature. It is widely reported that visual impairment has an adverse effect on quality of life, which may lead to depression and thoughts of suicide.
At the April 25, 2008 FDA hearing on post-LASIK issues, several speakers gave compelling testimony of the link between bad outcomes from LASIK and depression and suicide. LASIK industry representatives in attendance appeared unmoved.
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Byron L. Lam; Sharon L. Christ; David J. Lee; D. Diane Zheng; Kristopher L. Arheart. Reported Visual Impairment and Risk of Suicide: The 1986-1996 National Health Interview Surveys. Arch Ophthalmol. 2008;126(7):975-980.
July 19th, 2008
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
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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