The Dry Eye Zone

Rebecca's Blog

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4/25/08 FDA LASIK Hearing: What happened to compassion?

Expressions of compassion in a public venue can come in many flavors.

Planned.
Spontaneous.
Humble.
Condescending.
Generous.
Niggardly.
Heartfelt.
Convenient.

I’m not picky. On April 25th, so far as I am concerned, any of the above would have done. It’s not as though I went to the hearing expecting an outpouring of sympathy for complications patients.

I was thinking along the lines of a thimbleful or two of smooth, designed-for-television lip-service to the people who had brought about the hearing, before moving on to happier topics, like the more than 800 ecstatically happy physicians and their families that such and such a speaker has operated on over the years, or the excitement of being landed on an aircraft carrier by a newly lasered F17 pilot whose surgery was performed by such and such a speaker.

But we didn’t get the thimbleful.

Why?

You’re in a public venue, you’ve just heard a bunch of people pouring their hearts out about years of emotional and physical suffering from surgical mishaps, botched aftercare and the like. You’ve even seen photos of suicide notes and heard calmly spoken but gut-wrenching stories from loved ones.

It’s as natural to say it as it is unnatural to not say it:

“I’m sorry for the pain you people have been through.”

But no.

Why?

It seems to me that logically there are three explanations:

One, you don’t get it.

Two, you get it and you don’t care.

Three, you get it and you care but acknowledging the existence and plight of an unfortunate minority is inexpedient.

Let’s try those one at a time.

1. Is denial a plausible explanation?

The physicians representing the LASIK industry that day are among the best-known and most respected in the country.

I cannot believe that, given their clinical experience and research background, they could have failed to grasp something of the life impact of severe post LASIK dry eye. In fact, I would argue that a working knowledge of the published medical literature on dry eye is all you need.

Furthermore, it is statistically implausible that any of them have not, by now, had some LASIK patients of their own with severe dry eye symptoms, some with distressing vision quality symptoms, and some with both. Even if that were not the case, it is certainly the case that they are all regularly consulted by patients with such symptoms whose surgery was performed elsewhere and who have come to them for a second opinion and further treatment opinions.

They can’t not get it.

To be honest, how anyone can have the audacity to act as though it’s not a problem is beyond me. I go to the trade meetings. Who floods my DryEyeShop booth looking for new dry eye remedies? The techs from the LASIK clinics. On the internet, what dry eye keyphrase fetches the very highest bids for click ads? “LASIK dry eye”.

There are even artificial tears marketed specifically for LASIK dry eye. Why is it we have “Laser Drops” in drugstores, but we don’t have “Sjogrens Drops” or “Menopause Drops” or “Geriatric Drops”? There are an estimated 4 million people in this country with Sjogrens Syndrome, of which severe aqueous deficient dry eye is a hallmark symptom. There are 7 million people who have had LASIK, 95% of whom are reportedly “satisfied”. Even supposing ALL of the “dissatisfied” 5% have dry eye, 350,000 people do not constitute a market for a retail eyedrop. Are pharmaceutical companies stupid, or do they understand patients’ needs that much better than the doctors do?

Denial? No way. The ophthalmic profession knows full well that LASIK dry eye is widespread and that a non-trivial number of the people with LASIK dry eye are in real distress for want of effective remedies.

2. Is sheer callousness to suffering the answer?

Engineer type. Perfectionist mentality. It beats me how these people can keep whining about a little bit of halo and starburst. I mean come on, I got him to 20/15 unaided! ... This gal is always talking about pain. I swear her corneas are white and quiet every single time I’ve looked at them, no staining, no nothing, but she just goes on and on. Another Restasis script and out you go. I’ll give her a couple of extra samples of Optive this time.... Boy, I wish there were a way to screen out the loonies, you never really know when someone’s going to go off the deep end about the slightest thing.... Real shame about this guy’s spherical ab, never seen such high numbers, but what can you do. Can’t take it personally. Stuff happens when you’ve got this many patients.... Why is Mrs. X still coming back? I thought I told you not to schedule any more follow-ups for her. There’s nothing more we can do for her.... Nancy, I overheard a patient talking to somebody in the waiting room about their dry eyes. I told you not to put those types in the general waiting room – use the small one at the back. It was full? Well put them in a room somewhere, don’t leave them out front for heaven’s sakes....

I know this brand of surgeon well. And no, of course I’m not suggesting that leading surgeons think this way. I’m merely pointing out that if wilful ignorance and authentic callousness are not the explanation for the failure to express any compassion towards the casualties of refractive surgery, there is only one other explanation:

3. Expediency.

Expediency carefully measures each and every statement in the light of how it could impact public perception of one’s trade and/or personal standing amongst one’s peers. Expediency consequently refrains from any public acknowledgement that (a) unpleasant outcomes impact significant numbers of people, and (b) for some people there are no successful treatments.

I can see all too easily how one might feel one can’t risk it. You just never know what the press might zoom in on. You’re one of the best-respected refractive docs in the country. You’re up there in the spotlight. Suppose you are the one that unwittingly provides the fatal soundbite to the press admitting that there are some truly unfortunate casualties out there. Think of the repercussions.

So expediency says things like:

There are many exciting new therapies under FDA evaluation....


Ha. Like rebamipide and pimecrolimus? Today’s exciting new therapies are tomorrow’s footnotes in a megapharma’s financials. On my clinical trial roster I have at least 25 exciting new therapies for dry eye in some stage of clinical research. How much money would you stake that 5% of those make it through Phase III clinicals? Restasis, for all its blockbuster sales now that it’s being prescribed for every indication that it was not approved for, narrowly squeaked through approval after failing twice. Once-promising diquafasol failed three times and has had to start over. So far as I know there is currently nothing anywhere near FDA approval. Mind, I’m pleased and very grateful that research is being done, but given the track record of dry eye drug clinical trials, the potential for new drugs is neither an adequate consolation to all the patients currently up a creek nor a sound basis for risk evaluation by future LASIK candidates.

Dry eye syndrome is extremely common... Severe dry eye post LASIK is extremely rare. (Dr. Donnelfeld)


.........
(Dr. Solomon)

.........
(Scott Barnes OBO Doyle Stulting)

.........
(Dr. Schallhorn)

Et cetera.

Dry eye? What dry eye? Perhaps if we don’t talk about it, or if we act like it’s no big deal, the press and the public won’t think about it. After all, that policy has served us well for years. Never mind the evidence in the published literature, in our practice, at the professional meetings, and on the drugstore shelves.

Expediency can somehow hear of 5 different suicides connected to LASIK complications and look supremely unconcerned.

But most significantly:

Expediency diverts attention from real numbers of real, specific, prevalent complications - dry eye syndrome and glare disability - and focuses instead on THE RED HERRING OF PATIENT SATISFACTION. (The topic of my next post – stay tuned.)

But I’m not done with compassion yet.

The people I know with severe LASIK dry eye or other complications are real, live people.

They’re not some nameless, faceless 5% - or “possibly fewer than 1%” depending who you were listening to.

They’re real people.

Bankers.
Nurses.
Lawyers.
Soccer moms.
Psychiatrists.
Soldiers.
Builders.
Cashiers.
Computer programmers.
Judges.
Truck drivers.
Insurance adjusters.
Ophthalmologists.
Ministers.
Policemen.
Teachers.
Retirees.

They’re real people, and they deserved a lot more from the ophthalmic profession than they got that day.
Rebecca1 Comment