4/25/08 FDA LASIK Hearing: My letter to the FDA

Some of you may recall that when the 4/25 meeting was scheduled, the FDA invited the public to submit information in writing and/or request an opportunity to speak at the hearing.

The letters submitted in writing were all made available for viewing at the meeting. I leafed through the binder - there were stacks upon stacks of emails. It was interesting reading. Many were, of course, from complications patients. There were also many testimonials from happy patients.

For what it's worth... here is the text of the letter I sent to the FDA.

------------

Ophthalmic Device Panel
Division of Ophthalmic and ENT Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Food and Drug Administration

To the Members of the Ophthalmic Device Panel:

Re: April 25th meeting / LASIK

I am very grateful for the opportunity you have provided for the public to share their post-market experience with LASIK. I am writing to you on my own behalf and in two additional capacities:

1) As president of LaserMyEye, Inc., a 501(c)(3) nonprofit foundation I helped found which runs an informational website and online support group for people with complications from laser refractive surgeries; and
2) As founder and owner of The Dry Eye Company, which sells consumer products designed to improve quality of life for people suffering from dry eye, runs internet support groups, and collects and disseminates current information about the diagnosis and treatment of dry eye diseases.

My personal experience with LASIK

I underwent bilateral LASIK for high myopia and astigmatism in California in July of 2001. My surgeon is a highly trained cornea fellow with impeccable credentials. The excimer laser was a VISX Star S3, advanced technology at that time and still in common use. I considered myself a well informed patient. I was 32 years old at the time with healthy eyes and a stable refraction, and I was told I was an excellent candidate. I experienced no intra- or post-operative complications. I was given a videotape of my surgery which revealed no obvious errors. Nearly all my refractive error was eliminated in a single procedure.

Notwithstanding this superficially excellent result, I lost five to six lines of best-corrected visual acuity in each eye due to unexplained irregular topographical changes and high order aberrations. I also began to experience severe symptoms of dry eye, which worsened and have continued to this day. After two years of seeking treatment for the vision loss from some of the best international experts, including a second surgery on one eye which resulted in further loss, I had to leave a fulfilling and demanding career in international aviation finance due to poor visual performance and eye pain. I had no income source for approximately three years. I continued to seek treatment with large rigid gas permeable lenses with limited success. In 2006 I was successfully fitted with the Boston scleral prosthetic device (18.5mm custom lathed rigid lenses which hold fluid over my corneas). This has enabled me to work regular hours consistently. I wear these lenses all day, sometimes supplemented with moisture chamber eyewear for additional relief, and I employ various devices and products such as moisture goggles to protect my eyes at night. I am also heavily dependent on eye drops which proved so uniquely effective in my case that I purchased manufacturing rights to them in order to ensure their continued production.

While I have accepted my personal experience of LASIK and I would not hesitate to describe myself as a very happy person, there is no denying that for many years LASIK dramatically impacted my life physically, emotionally, professionally and financially, and it continues to affect me physically on a daily basis.

My qualifications to speak on behalf of other LASIK patients

Not long after my surgery, I discovered large numbers of unhelped and apparently unhelpable complications patients on the internet. I began engaging in informal patient advocacy work. While living in the United Kingdom (2002-2004) I counseled complications patients, undertook speaking engagements at medical conferences, ran a popular website for laser eye surgery patients, and lobbied for, then assisted in the proceedings of a special parliamentary committee to regulate the laser eye surgery industry in the UK

Since moving back to the US, I have engaged full time in helping fellow patients in any way I can devise. I joined with others to form nonprofit LaserMyEye, Inc., which took over the website I had personally formed and added an online community for patients to network. Later, I formed The Dry Eye Company (TDEC), in part to restore to commercial production three ophthalmic demulcents which had been sidelined by the industry but which have been remarkably helpful to many LASIK dry eye patients. TDEC now runs several popular consumer websites, an internet store with more than 75 specialty products for dry eye patients, an online ‘support group’ with more than 2,000 members and several doctor contributors, physician directories, product consumer reviews, newsletters and blogs. While it is aimed at dry eye patients of all kinds, LASIK dry eye patients represent a significant percentage of TDEC’s users and customers.

During the years 2002-2008, first as a patient advocate by hobby, then as founder and president of LaserMyEye, and finally as proprietor of The Dry Eye Company, I have personally interacted with at least 1,500 LASIK patients via telephone, support group meetings, email, and internet forums. Most of the remainder of this letter, in which I outline my key concerns with LASIK, is based upon those interactions and the research I have done on behalf of LASIK patients who have contacted me.

Problem #1: Clinical depression

The single most consistently recurring theme in all my personal dealings with LASIK patients is depression. Based on their own representations to me, I estimate that at least 85% of the patients I have interacted with have experienced clinical depression following their surgery. Furthermore, a disturbing number of these patients indicate they have experienced suicidal ideation. I have personal knowledge of several patients who have planned or attempted suicide and one patient who committed suicide, and I have second-hand knowledge of additional close calls and one further actual suicide.

The high incidence of depression following LASIK seems to be associated with the following patient experiences:

* Lack of validation:
o Physician disbelief of patient’s reported symptoms, e.g. glare disability; severe dry eye pain
o As a result, physician failure to order appropriate diagnostic tests, e.g. wavefront analysis
* Ineffectual treatment for dry eye pain. It does not seem to be widely recognized in the medical community how intense dry eye pain can be and that unremitting dry eye pain can drive patients do distraction. In TDEC’s online support group (dryeyetalk.com), new members of all ages and walks of life routinely describe how their lives have been completely turned upside down.
* Unexplained and untreated visual symptoms (usually glare disability). As with dry eye, these symptoms can be experienced in a degree which is extremely distressing to the patient while physicians remain dismissive of its impact upon their lives.
* Impact upon work performance, leisure activities, driving ability, and home life.
* Impact upon relationships.
* Sense of isolation (physician says they are “the only one” reporting such symptoms; family and friends do not understand).
* Financial stress from medical costs and fears about future income loss.
* Self-blame due to the elective nature of the surgery.

Problem #2: Lack of remediation for the top two adverse effects of LASIK

Considering that I have dedicated a large part of my professional life to meeting consumer demand for information about treatments for dry eye and vision quality complaints from LASIK, I am well positioned to describe the plight of a special class of LASIK patients: The unhelpables.

LASIK is creating a non-trivial number of “unhelpable” patients. They typically share the following characteristics:

* They suffer from severe dry eye symptoms, reduced vision quality or both.
* Their occupation and personal lives have been profoundly impacted.
* Their relationship with their surgeon or other physician(s) responsible for their post-operative care has been discontinued, due either to frank abandonment (e.g. surgeon tells patient not to come back because s/he cannot do anything more for them) or voluntary departure by the patient because of the surgeon’s evident unwillingness and/or inability to help them.
* They have sought additional opinions from several doctors. Many travel nationally and internationally seeking out the best known specialists.
* They tirelessly research and attempt potential treatments. Some know more about current research, new products, and clinical trials than clinicians.
* They congregate on patient websites trying to glean new information and, most of all, to gain some hope for the future.

Of these, none speaks more plainly to the failure of remediation than patient abandonment, whether occurring in a medico-legal or strictly moral sense.

Why is this happening?

First, there is a persistent reluctance to admit to the troubled patient what is evident throughout published medical literature and is talked about openly in medical circles: that dry eye and vision quality problems are not only real and measurable, but are not even unusual. A problem that is not acknowledged is not treated. Without validation or treatment, the patient’s anxiety escalates, and the relationship rapidly breaks down.

Second, there is a fundamental disconnect between what a surgeon considers to be a successful LASIK procedure, i.e. a patient with a greatly improved uncorrected visual acuity, and what a patient considers to be a successful LASIK surgery, i.e. a surgery that by and large leaves them better off than they were. Patients with enough pain will consider themselves worse off no matter how good their vision is. Patients with severe enough vision quality problems will consider themselves worse off no matter what line they can make out amongst the ghosts and fuzz on the eye chart. Patients with poor vision quality and in pain are just downright miserable by any measure. Yet some LASIK surgeons persist in a kind of willful agnosia for patient complaints if the patient can, squinting and grimacing, make out some characters on the 20/20 line.

A classic example of this appeared in a New York Times article on 3/13/2008. The journalist chronicles her personal experience with LASIK. She is manifestly dissatisfied with her outcome due to persistent dry eye and poor vision quality. Her surgeon, when interviewed for the article, states that she considers the patient’s procedure a success. The surgeon is even quoted as saying “In 18 years of practice, I’ve never had a patient whose symptoms don’t go away.”

There is, of course, a simple explanation for this kind of claim:

The symptoms did not go away. The patients did.

It’s called “lost to follow-up”.

Problem #3: The myth of voluntary post-market reporting

The FDA’s policy of reliance on voluntary reporting of adverse patient outcomes by LASIK surgeons and device manufacturers is an abject failure. Physicians, and possibly manufacturers, have a poor understanding of their reporting obligations. Physicians and manufacturers alike have glaring financial disincentives to report poor patient outcomes. To grasp the reality of this, one need only look at the stark contrasts between adverse event incidence as reported in (a) device labeling, (b) published medical literature, and (c) the FDA’s MAUDE database.


Conclusion

Ocular surface disease and glare disability secondary to LASIK can be so physically and psychologically devastating that they deserve “black box” warnings.

Sincerely,

Rebecca E. Petris