The Dry Eye Zone

Rebecca's Blog

-

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

(Continued)

RICHARD LINDSTROM MD
LASIK surgeon. Immediate former ASCRS president. Dr. Lindstrom was unable to attend due to illness and a statement was read on his behalf by Kerry Solomon MD.

We find all available clinical data reinforces the safety and efficacy of LASIK....


(An aside: I think this quote effectively sums up the collective input by surgeons speaking either on their own behalf or on behalf of professional societies on Friday. I will save any further comment on what’s glaringly missing from that response for another post.)

His message to complications patients was:

We hear, we care, and we are responding. The satisfaction rate of LASIK is higher than that of any other elective surgery, but it can be improved. We’re here to understand the subjective reasons for dissatisfaction.


I noted down only one other items from Dr. Lindstrom’s statement:

The primary patient advocate is the patient’s physician.


ERIC DONNENFELD MD
LASIK surgeon

Like all the LASIK surgeons who spoke at the hearing, Dr. Donnenfeld is one of the top leaders in his field. (I believe he stated that he was attending as representative of ASCRS but I need to confirm this.)

Dr. Donnenfeld described at length his passion for improving quality of life in his LASIK patients and explained that he has peformed LASIK on 800 doctors and their families. He stated that LASIK has always been very safe. He compared the risk from contact lenses to the risk from LASIK.

Dr. Donnenfeld was the only one of the doctors presenting that directly addressed dry eye. I have been trying hard to refrain from commenting on the presentations while I’m describing them and here, and I’m about to make my first major exception. Between the outrageously misleading character of some of the statements and the eggregious abuse of medical literature in support of them... On second thought, this deserves its own blog post, so I reserve further comment.

Dr. Donnenfeld began by saying that an estimated 55 million Americans suffer from dry eye, including people who have had LASIK. He went on to describe how the recently formed LASIK task force undertook an extensive review of the medical literature. Charts, graphs etc. in abundance of all the peer reviewed articles. The results here presented were as follows:

- 32% of people experience pre-operative symptoms of dry eye
- 35% of LASIK patients experience post-operative dry eye.
- Severe dry eye post LASIK is “extremely rare”.

Dr. Donnenfeld talked about how there are many exciting therapies under FDA evaluation.

Dr. Donnenfeld’s bottom line message was that LASIK improves lives. He was cut off for time when he launched into a story about a transplant patient of his.

DOYLE STULTING MD
LASIK surgeon. Emory University. Editor-in-chief of Cornea (a peer-reviewed medical journal).
A statement was read on his behalf by Scott Barnes. Mr. Barnes was in military dress but I did not manage to hear his rank.

I took only very cursory notes of the statement by Dr. Stulting. I think this is where I was distracted by the person next to me, or perhaps I was even suffering from a little ennui. I’ll indulge just this once in simply reproducing my unabridged scribbles:

“Another AMO consultant. Focuses on those with less NVD after than before. Better technology, better screening etc. Blah blah. How much it helps the military.”

KERRY SOLOMON MD
LASIK surgeon. Storm Eye Institute.

Like Dr. Donnenfeld, Dr. Solomon focused on ASCRS’ recent medical literature review about patient satisfaction and quality of life. He talked about the 95% satisfaction rate being higher than all other elective surgeries.

ODP chair Dr. Weiss took the trouble of clarifying at the end of Dr. Solomon’s talk that ASCRS had conducted that literature review off their own bat, not at the request of the FDA.

TODD KROUNER
Attorney.

Mr. Krouner urged the FDA to be independent in the QOL study they are undertaking. He said that since the industry is convinced there is such a high satisfaction rate, they should welcome independent confirmation of that.

He talked about how complex the LASIK screening process can be.

He discussed the problem of industry under-reporting of post-market device problems and is concerned about mandatory reporting not being enforced.

He showed some nice visuals demonstrating the difference between vision quality and acuity and discussed what he termed the dishonesty of claiming LASIK success based on uncorrected acuity (i.e. what line you can read on the chart) alone. He used as an example the recent story of Abby Ellin in the New York Times.

PETER MCDONNELL MD
LASIK surgeon, Wilmer Eye (Johns Hopkins)

I had rather scanty notes on this talk.

Dr. McDonnell talked a bit about technological improvements.

He stated that many patients seek LASIK because of dry eye symptoms wearing contact lenses, and some get dry eye syndrome afterwards. Talked about how contact lenses have their own risks. (One of my notes to myself is the implication that LASIK may be safer.)

NAME?
This is the only one I did not catch at all. She is on the “joint task force”, represents ASCRS (I think?), has a background in psychiatry and psychosomatic medicine, and is or was a Navy physician.

Like others she talked about wanting to better understand the “small number of dissatisfied individuals” and their “subjective experiences”.

She discussed quality of life as being comprised of both physical and psychological factors.

She stated that 20 million people in the US suffer from depression and emphasized that depression is almost always multifactorial, extremely unlikely to be caused exclusively by a single event. She indicated many other key factors include background, personality, coping skills and genetics.

If I didn’t happen to know better from my many years of interacting with depressed LASIK patients, my take-home message (and it’s a relatively easy sell to an unsuspecting public) would have been that there is something already wrong with these people who get depression after LASIK.

STEVE SCHALLHORN MD
LASIK surgeon. Ex Navy. I will have to doublecheck when the transcript comes out but it was my impression he was present representing the AAO.

Another one for which I had scanty notes. He said something about quality of life results being a different matter than safety and efficacy and emphasized that sometimes there are simply other factors in patient satisfaction that we can’t explain.

He told a story about a firefighter and contact lenses and I got distracted somewhere during it.

DR. TERRI ETHBANKIS (sp?)
Psychologist? I did not catch the details – apologies.

Physician counselor for LASIK complications support groups for several years. Discussed depression and anxiety related to LASIK outcomes.

Also discussed some future eye health concerns for LASIK patients as they age, including more complicated cataract surgeries and possible future complications because of the flap interface.

She talked of LASIK problems as an open secret and described it as a disgrace of modern medicine.

KIM HARBINGER
Patient with complications. Statement was read on her behalf.

Kim was a nurse who had RK 14 years ago. Her prescription regressed and in 2006 she underwent LASIK by a surgeon who told her it was “no problem”. (For those who don’t know, LASIK over RK is anything but “no problem”. Cutting a flap in a cornea that has a whole bunch of incisions in it from RK is ticklish business to say the least.)

Her complications left her depressed and suicidal and this was described at some length. Hard contact lenses have now improved her vision.

Her bottom line: “Medical remedies trial medical advances.”

DR. MICHAEL MULLORY
Patient with complications.

Dr. Mullory pushed for mental health professionals to be the ones studying quality of life after LASIK. He discussed a publication in a medical journal about fear of vision loss and its relation to suicide risk which was really quite interesting and ties into something I’ll be posting about later on.

He asserted that depression screening for patients before surgery (which has been suggested by some in the industry) is not the answer, but that stopping vision loss is.

He told the story of “Ajay”, with severe depression despite no mental health history, and additional stories of patients with suicidal ideation, all involving patients whose doctors considered them “successes” based on their visual results. One such patient, who underwent a transplant, he said had their concerns compounded by a sense of collusion in a medical community where none of the local doctors consulted told her she had ectasia.

Dr. Mullory called for a moratorium on LASIK but suggested that if this was impracticeable then the device labelling should include depression and suicide as risks.

COURTENEY HENDRICKS
Patient with good outcome. Quadraplegic.

ASCRS paid for Courteney to attend the meeting. Her story was similar to Barry Elbasani’s – loss of independence, and a wonderful sense of regaining a small piece of independence by no longer being dependent on others for things like wiping smudges from her glasses.

AMANDA CAMPBELL
Widow of complications patient who committed suicide. Unable to attend; attorney Todd Krouner made presentation on her behalf.

Mrs. Campbell is the widow of Lawrence Campbell, who committed on March 16th, 2008. Mother of two children, she could not afford to come because of her situation.

She shared details of his suicide note. It included a detailed description of how unremitting pain from chronic dry eye limited his activities and affected him emotionally, and how he did not want to live out the remainder of his life on Xanax.

The note concluded with the statement “Do not have LASIK surgery. Tell the media.”

Mrs. Campbell said he had no mental illness history whatsoever and that LASIK was unquestionably the contributing if not the sole factor in his suicide.

She (or Mr. Krouner?) named the laser center where the surgery was performed, stated that they did not know whether malpractice occurred, but also stated that the widow and children had so far been denied access to Lawrence’s medicla records.

Mr. Krouner ended with a request that the FDA’s work be more transparent. He complained that he had filed a Freedom of Information Act request with the FDA with respect to Alcon related documents 9 months ago and had not received them. At that point he was cut off by the chair.

ROGER DAVIS PHD
Patient with complications. Clinical psychologist.

Dr. Davis talked about his involvement with The Surgical Eyes Foundation, and having studied 300 complications patients 100 of whom indicated they had experienced suicidal ideation. 83% of those indicated they had been told their surgeries were successful.

In his study he found that dry eye syndrome was more closely associated with depression than any other complication.

Dr. Davis’ term for the psychological phenomena these patients experience is Refractive Surgery Shock Syndrome.

He went over the “stages of inquiry” complications patients go through. I did not catch all the details but it definitely struck me as the most compelling attempt of the day to put people into the head of the LASIK patient. Towards the end of that part he discussed the different paths patients take and where those lead them, including:
- Some patients travel all over the world to specialists, fail to get effective treatment, and just want to be at the end of their journey. [Hence suicides.]
- Some start websites, in order to get some empowerment.
- Some are just barely coping, and have no energy left over for activism.
- Some feel no one anywhere understands them, and that by taking their lives at least people will finally understand how much they have been impacted by their surgery.

Dr. Davis called for the FDA study to look into informed consent and the standard of care. He also said “Forget the quality of life survey. Study the suicidal patients.” He called for a moratorium on LASIK.

JOANNE WILLS on behalf of KEITH WILLS?
Complications patient.

I only caught the barest scraps of this one. LASIK in 1997; part of an investigational study but the patient was not told. Had 7 surgeries to correct initial problems.

SOMEONE FROM MILITARY

I was preoccupied during this one. The speaker expatiated at some length on safety issues for soldiers in the field, and the benefits of LASIK.

JOSEPH SCHNELL
Complications patient.

Mr. Schnell underwent LASIK in 2007 at Lasik Plus. He said something about Scheie Eye and Wilmer – I am not sure if these are places he went for treatment afterwards. He considers his eye health much worse after surgery and described vision quality problems. He described anxiety attacks and other effects the surgery has had on him.

I am pretty sure this was the end of the scheduled speakers – at any rate it’s all I’ve got notes on. Sorry if I left anybody out.

ED BOSHNICK OD
Optometrist

Dr. Boshnick is one of several optometrists who have put a lot of time into treating complications patients with specialty contact lenses. I did not have any notes on what he said because I was hastily scribbling some notes for myself as I had just been called.

REBECCA PETRIS
President, LaserMyEye Inc. (501(c)(3) nonprofit) and founder/owner, The Dry Eye Company

Oops, that’s me!

I had previously sent in a letter to the FDA for the hearing’s written records. I had also missed the deadline to request a speaking slot, and felt that with the crowds who wanted to speak, it was extremely unlikely I’d be called on. I did not prepare a speech, and even if I had, after witnessing the morning’s proceedings, I don’t think I could have brought myself to read it.

Instead, I winged it. It was a bit of a blur afterwards, but I’ll share some bits and scraps that I remember.

I told the panel briefly about my change of career as a result of my LASIK, how I founded LaserMyEye and later The Dry Eye Company. I told them how grateful I was for the opportunity to speak and how I had missed the deadline to request a speaking slot because of being preoccupied with my work with people with dry eye. I told them I had flown out from Seattle on the last redeye flight Thursday night to attend the hearing because I had not been able to tear myself away from the phone.

I described a two-hour conversation that Thursday morning with a young man in Arkansas who was near suicidal as a result of his struggles after undergoing LASIK just 3 months ago, and I talked of how many of these conversations I have regularly with people 3 months, 6 months, 1 year, or many years after their surgery. I talked about unremitting pain from dry eye and what it does to people.

I told them that as regards depression, I agreed with the presenter who insisted that depression does not come from a single event. I said that for patients it’s not a single event (surgery) – it’s what came before (poor screening, poor informed consent) and what came after – complications, poor care, lack of validation, inadequate treatment, and pain, pain and more pain.

I said that there were many doctors in the room and I wished they could be flies on the walls of my office on a typical day to hear the calls from patients looking for help. I said that we had heard a lot from LASIK surgeons that day about improvements to technology and about how exciting all the capabilities of LASIK are. I said that what we had not heard was any compassion for those who experienced problems. I said that if there were any compassion to be had, the doctors and professional organizations should be rallying around the consumer groups offering practical help and support for complications patients.

------

This was followed by a few questions from the panel for one or two of the doctor speakers. That was pretty much it for the public hearing part of the day’s proceedings.
RebeccaComment