4/25/08 FDA LASIK Hearing: The open public hearing (1 of 2)

Now that I’ve gotten warmed up, I’ll move on to the proceedings themselves.

The whole of the morning (8:45 to 11:30 am) was dedicated to pre-scheduled speakers, that is, people who had requested to be allowed to give a presentation about the "post-market experience". This opportunity was open to anyone and there was quite a variety of speakers as you'll see.

Each speaker was strictly limited to 5 minutes maximum. I'll take them in the order they presented. Apologies in advance to anyone whose name I didn't catch or have made mincemeat of.

NOTE: Throughout the notes I took, I used the shorthand “NVD” (night vision disturbance) whenever anyone referred to starbursts, haloes, “glare”, etc. So when I use that phrase in my descriptions below, it’s probably not what the person said, it’s just the term I use for it.

MICHAEL PATTERSON PHD
Patient with complications.

I've known Michael via email for several years and met him for the first time at the meeting.

Some highlights I noted from his presentation had to do with post-market surveillance, an area of FDA "un" or "under" activity that I fully agree about. The FDA has some voluntary and mandatory reporting requirements for surgeons and manufacturers but it's no secret that adverse events are woefully underreported. Michael was very critical of the FDA's inaction in the face of a manifest widespread problem with underreporting of excimer laser related adverse events.

Michael, like several later presenters, called for (among other things) a moratorium on LASIK.

DEAN KANTIS
Complications patient, LASIK critic and activist.

He shared quite a lot from his personal experience, including being sued by his doctor for publicly exposing the 40 lawsuits against his doctor. He claimed his family has been harassed and that he has even been subject to death threats.

Dean's key 5 points were about:
1) The truth about "the flap" and about pupil size.
2) Informed consent improvements that are needed.
3) Definition of a LASIK success. (This is a point raised many times throughout the hearing - the disconnect between what a surgeon calls a success and what a patient calls a success.)
4) The problem of post-market reporting of adverse events and how to enforce reporting of them if the FDA is not enforcing it.
5) The unseen emotional problems - depression and suicidal patients.

DAVID HARTZOK OD & BARBARA BERNEY
(statement read on their behalf by Glenn Hagele)
Representing Vision Surgery Rehab Network, a nonprofit 501(c)(3) group for complications patients. VSRN is the successor to The Surgical Eyes Foundation, a nonprofit founded by Ron Link that worked for many years on behalf of complications patients starting in the late 1990s.

The panel must be prepared to hear two extreme arguments today. VSRN believes both extremes are disingenuous.... We would like to start a dialogue with the FDA.

I was puzzled by the use of the word 'disingenuous'. I've often heard, and sometimes used, this word or synonyms in relation to the LASIK industry, but whatever criticisms the 'extreme' activists might at times lay themselves open to, being deliberately dishonest is not something I would ever associate with them. I think they are passionate and dedicated people even if I have differences of opinion or judgment.

With this single exception, I thought the VSRN presentation was excellent. The focus was on "Refractive Surgery Syndrome", comprised of physiological and psychological sequellae of LASIK and similar surgeons. They emphasized the critical importance of how doctors manage a patient with a poor outcome; and how the RSS problem was compounded by ineffective treatment. They asserted that wavefront has not eliminated the vision quality problems of the past. They talked on the theme of acuity (20/20 etc) as an inadequate measure of "success".

Bottom line:

There is a significant but unknown number of patients with Refractive Surgery Syndrome.

GERALD DORRIAN
Father of Colin Dorrian, who committed suicide in 2007, 6 ½ years after his LASIK.

Mr. Dorrian's talk was all the more poignant for being remarkably calm and measured. He described his son, a law student at University of Michigan with no mental illness history.

Colin was contact lens intolerant and had large pupils (two big red flags in my book – but which are routinely overlooked or dismissed by many laser clinics). He was told he had less than 1% chance of a worsening of any night vision complaints. After surgery, his long-term effects included starbursts/haloes, loss of contrast sensitivity, and dry eye. He made three different attempts at specialty gas permeable lenses, which are the safest and most effective form of treatment for these vision disorders, but was not successful.

Mr. Dorrian read from a letter Colin had written not too long before he took his life. In it he acknowledged he might even have “tended” to be a bit on the depressive side before but that until LASIK, he always managed to get by and bounce back.

Mr. Dorrian stated that people involved in refractive surgery need to take responsibility for the problems, not just broadcast the successes. He was then cut off as he had reached the 5 minute limit.

SANDY KELLER
Patient with complications. Founded (but does not currently run) www.lasikdisaster.com, a longtime popular website for information on complications. She was not present but a statement was read on her behalf by Glenn Hagele.

Sandy was one of the early LASIK patients with horrific complications and badly botched post-operative care. She had risk factors before surgery (large pupils, dry eye). The blade jammed during surgery. She developed Stage IV DLK. She found information and support from The Surgical Eyes Foundation (predecessor to VSRN as mentioned). She describes the betrayal she felt when she learned the financial particulars of the “co-management” arrangement between her surgeon and optometrist. She sued them and they each blamed each other. Her medical records were altered.

She described her emotional experiences as similar to PTSD. Her business suffered and she said that at times she wanted to die. At this point the reader lost composure and the chair proceeded to call another presenter. If there was any more to her statement I don’t think it was read.

DOMINIC MORGAN
Patient with complications and activist. Founded and runs www.lasikdecision.com.

Dom was another of the early LASIK patients with a true horror story. His surgery was performed with improper use of an investigational device. He never should have been a candidate as he had blatant contraindications (he was 20/50 BCVA and had retinopathy of prematurity). He states the he and many others were dropped from a study because of their complications.

His doctor sued him for publicizing details on his website.

He states that he filed a petition to the FDA in 2003 which was ignored.

Dom says that he has been contacted by hundreds of patients via email, some suicidal. He describes them as “ordinary people” with nothing to suggest they are “perfectionists” or have other characteristics physicians use to explain or dismiss dissatisfied patients.

Dom was critical of the involvement of ASCRS in the study that the FDA is undertaking and suggested that patients have no more reason to trust an organization of LASIK surgeons more than they trusted their individual surgeon. He suggested that it would be interesting to conduct a survey asking how many patients with complications feel they were lied to.

Dom concluded by suggesting that a moratorium on LASIK advertising would be an intriguing idea. I have an additional scribble in my notes that looks like “Patient selection or doctor selection?”

DAVID SHELL
Patient with complications.

David was another of the early (1998) complications patients. A former engineer, he described how after 50 years of healthy eyes he underwent LASIK and is now handicapped by constant eye pain and strain, and experiences distorted vision even with specialty gas permeable lenses.

David provided some images on posters to show how someone with, technically, good acuity can still have horrible vision. The posters showed a snellen eye chart with ghosting; pictures of starbursts on lights; and multiple moons.

In 2002 David testified to the FDA about LASIK dry eye, describing the constant burning and stinging and how his eyes never feel comfortable. He has been to experts around the country seeking treatment.

David called on the FDA to do three things:
1) Reclassify night vision disturbances (starbursts, haloes, glare and the like) and dry eye syndrome as a complication.
2) Conduct a truly independent study
3) Re-examine the safety and effectiveness of LASIK.

BARRY ELBASANI
(sp?) Patient with good results. He was not there personally but a statement was read on his behalf by Glenn Hagele.

Barry is paralyzed from the chest down due to a pool accident. He described how since his accident so many things that most people consider trivial are now much more difficult – including dealing with glasses or contacts. Being paralyzed he cannot even put them on and take them off by himself. Getting LASIK was a huge benefit to him because it’s one area of his life that he does not have to be dependent on others for.

GLENN HAGELE
President of CRSQA, a doctor referral/certification service. Runs www.usaeyes.org.

Glenn stated that quality of life has always been the yardstick for LASIK, and that expectations are central to patient satisfaction. I was rather taken aback when Glenn asked the ‘casualties’ (people with poor LASIK results) in the audience to raise their hand. I did not raise mine. I suppose the show of hands was a help to the press in finding people to interview, but personally I felt it was inappropriate.

Glenn presented results from his “CORE Survey”, a patient satisfaction survey conducted between March 3 and April 16 with a 31% response rate. 99% said that their quality of life was as expected or better.

Glenn did not present the data on night vision symptoms or dry eye “due to time constraints”. Most unfortunate, from my view, considering that night vision symptoms and dry eye are acknowledged to be the most frequent causes of complaints.

DIANA ZUCKERMAN PHD
President of the National Research Center (NRC) for Women & Families. Expert on national health policy and women’s health.

Dr. Zuckerman mentioned that there were a lot of problems with surveys that rely on subjective assessment and self-reporting “such as you have just heard”.

She told us that there was very good information available about LASIK on the FDA’s website – “but who reads it?” She was also critical of the FDA’s patient information booklets as being far too sophisticated for the average reader, even going so far as to state that they read as though they are designed to satisfy someone at the FDA without respect to what actually helps patients.

She talked about eye pain and dry eye as being the most common complaints (hear, hear!!) and referred to specific study numbers in the 20% range at 6 months post-operatively.

She said that the possibility of an unusually high suicide rate has been raised and needs to be researched.

Dr. Zuckerman concluded with the statement that overall, patients do not have informed consent. Healthcare practitioners are focused on the consent rather than the information. Informed consent is a process, not a piece of paper.

LAURANELL BURCH PHD
Patient with complications.

Dr. Burch accused the industry of trying to re-frame the discussion the FDA has opened. She said that Dr. Kerry Solomon had been quoted as saying “This is not about safety and effectiveness”, but she felt that if this was true, “We would not be here”.

She raised many future health concerns for eyes that have undergone LASIK and felt that nobody would get LASIK if these were fully understood. She cited specific examples, including:
- Flap-related issues (non-healing; structurally weakened cornea at risk of ectasia)
- Potential complications for future cataract surgery
- Potential inaccuracy of intra-ocular pressure measurements

Dr. Burch stated that patient satisfaction surveys are not the right target and that instead we should be measuring vision quality loss and dry eye syndrome. (Hear, hear.)

MATT KOTSOVOULOS
Patient with complications.

Matt’s situation is quite different from some of the other patients because his surgery is recent (2006) and took place with the very latest technology (Intralase and wavefront) at a highly reputed center (Duke University, where he was CFO of the eye center at the time of his surgery).

Since his surgery, Matt says he experiences constant eye pain. He complained of unethical marketing, and specifically referred to dry eye and night vision problems being classed as “symptoms” rather than complications. Like Dr. Zuckerman he referred to an OSU study showing a 20% rate of worsened dry eye symptoms after LASIK and 15% night vision symptoms.

Matt said that the LASIK industry wants to use a high satisfaction rate to imply a low complications rate, but asserted that these are two entirely different matters.

Matt said he has met plenty of people who are depressed or even suicidal because of “side effects” not classed as complications.

In conclusion he called for a moratorium on LASIK, and wants to see studies of complications including depression. He wants night vision disturbance and dry eye syndrome to be classed as complications.

BETH KOTSOVOULOS
Wife of patient with complications

I noted this one down as one of the most compelling of the day. It gave us a snapshot of what a poor outcome of LASIK does to your average American family.

Beth described how severe dry eye “almost destroyed our family”, how Matt experienced post-traumatic stress disorder and suicidal ideation.

She called on the surgeons present to try to be objective about this and really listen to what patients are experiencing when they have these kinds of results.

Her message to the media was also clear: The minority matter – not just the happy majority.

She called for an investigation into the link between LASIK and depression, and referred to many examples including:
- Two LASIK suicides. (Note: These are in addition to any other suicides discussed Friday morning. Incidentally, one of them is a patient I was personally closely acquainted with.)
- An army major currently stationed in Iraq (side note – he is a longtime member of Dry Eye Talk known to many in the online dry eye community)
- A lady named Linda who underwent cancer 10 years ago and never experienced depression, but who found that a 20-minute eye surgery turned her life upside down.

Beth described LASIK complications as wreaking havoc on American families – not as the straw that breaks the camel’s back but as the 200 lb gorilla. Her last remark before being cut off by the time limit was to call on the FDA to investigate clinical depression and suicide connected to LASIK.