Thursday, May 1, 2008

4/25/08 FDA LASIK Hearing: LASIK and the military

I can’t think of a single thing that got my back up at Friday’s hearing so much as the military brass. I went from being merely curious when I walked in that morning and saw all the uniforms in the room, to being very sore by the end of the day.

Very, very sore.

Here is why.

ONE

I’d like to know who invited the DOD, and accorded them special treatment, and why.

Military personnel had their opportunity along with the rest of us in the public hearing session. The 29th presenter (by my count... and unfortunately the only one whose name I did not catch) expatiated at length on the benefits of LASIK to the military, and this was further bolstered by comments from a military man speaking on behalf of Doyle Stulting MD and also from (ex Navy) Steve Schallhorn MD. Fair enough.

But why was the military given the opportunity to hold a 15 minute cheerleading session for LASIK Friday afternoon during the FDA/ODP sessions?

Enquiring minds want to know.

TWO

If Friday’s presentations are anything to judge by, I believe the military are in denial when it comes to dry eye from LASIK and PRK – its incidence among military personnel; its impact on the safety and wellbeing of our active duty service people; and its impact on our veterans.

I listened carefully for the words “dry eye” during those presentations. Presenter #29 did not mention it. Commander Tanzer in his 15 minute session did not mention it even in his listing of complications.

Why? It is well established in all the published medical literature as the most frequent problem after LASIK and has been for many, many years. Even the Journal of Refractive Surgery, printed a study in April concluding “LASIK-induced dry eye and neurotrophic epitheliopathy are common complications of LASIK surgery....” It's no secret.

Yet the Navy’s apologist for LASIK did not deign to spare even 15 seconds of his 15 minutes to pay a little lip service to this well known problem.

We were told that 224,000 procedures have been performed on the military.

I have three questions about this:

1. Has anyone bothered to find out how many of those people have chronic dry eye?

If you have, great, show me the numbers! But they had better be real numbers using a scientifically validated instrument to measure patient symptoms, such as the OSDI.

Until you take the trouble to do this, it’s not hard for us to calculate a probable minimum number. Based on the published medical studies, it could be anywhere from 5% to 36%. (Figures like 15-20% at 6+ months postop were mentioned many times Friday as there are many excellent studies with numbers in that range.) But this is the military, meaning it’s younger and much more male-dominated than the LASIK market at large. And they’re almost certainly getting better treatment than the local 2-for-1 bait-and-switch laser clinic. So let’s give them maximal benefit of the doubt and suggest the actual rate to be as low as 5%. That’s, let me see, a mere 11,200 military service people. Clearly not important enough to tell the FDA or the American public. Especially when glowing reports of increased safety and even “super-vision” are so much more exciting and inspiring.

2. Has anyone investigated how severe or chronic dry eye from LASIK is affecting active duty military and what kind of care they are getting?

Sorry, I didn’t catch your answer. Come again?

3. Has anyone investigated how dry eye from LASIK is affecting our veterans and what kind of care they are getting?

I didn’t think so.

Moving on now from statistics and probabilities to particulars and facts:

Does Commander Tanzer know how many people are registered in our D’Eyealogues forums for LASIK complications patients, or our DryEyeTalk forums for dry eye patients, with email addresses ending in .army.mil, or .navy.mil, or .af.mil?

I do.

Does Commander Tanzer know how many military personnel have registered in these forums under yahoo or gmail accounts?

I don’t either.

Does Commander Tanzer know how many of my customers for moisture chamber goggles and such are active duty military?

I do. (Except, of course, for the ones whose families are purchasing them and sending them on.)

Does Commander Tanzer know any military doctors with severe dry eye stationed in Iraq right now?

I do.

Does Commander Tanzer know any military personnel stateside who have been cast to the winds by the VA - while struggling with, say, recurrent erosions more than a year after PRK? People who now have to pay out of pocket for everything they need – moisture goggles, over-the-counter lubricants, and so on?

I do.

THREE

I’d like to know exactly what kind of informed consent our military is getting when they undergo LASIK.

Informed consent is a serious problem for us civilians. What is the military doing to make sure their personnel understand the real risks of dry eye and night vision disturbance?

The military spoke eloquently Friday about the benefits of LASIK to soldiers in the field, compared with risks of glasses or contacts.

But I’ll wager that some soldiers could speak even more eloquently about what it’s like to get a spontaneous erosion out there in the field. I’ve had women tell me that giving birth was far less painful than the corneal abrasions they've had since they got LASIK dry eye. Now I know our military are tough folks and are willing and able to withstand a great deal in service to their country, but to the extent they have to suffer, I do not want it to be as a result of a procedure they voluntarily underwent in order to become more efficient for their country - without being accurately and fairly informed of the risks by those whose job it is to promote their wellbeing.

I challenge Commander David Tanzer, the United States Navy, and the Department of Defense to take a closer look at the other side of the LASIK coin.


I’d better stop now before I get really worked up.

We’ve all got our biases. Here’s mine: I’m one of the people quietly trying to help pick up the pieces when someone’s great plans for someone else’s eyes have unintended consequences. You’d better believe it’s left me with some chips on my shoulder, and what’s more, I’m not ashamed of it.

1 comment:

Erik Rupard said...

Well said, Rebecca.

Having a few poorly-informed people make decisions for a large, captive audience--unfortunately, all-too-often that is the military way. As I have mentioned to you privately, I constantly come across military members with dry eye post-LASIK, but most of them just "suck it up" (also, a feature of the military).

Re: informed consent. I can speak for myself only, and I acknowledge that my case may be a bit different, as I am an officer and a physician. But I was put through a few classes about PRK and LASIK before I was even allowed to choose among them, and I indeed did sign a lot of papers describing side effects before I could get LASIK.

However, there is another troubling issue here: the military is very strict about enlisted members of the military being enrolled in trials in which they get remuneration in any way, because those kids are pretty susceptible to taking any $$$ offered to them (as has been seen in a few sad cases in the past). To me, the LASIK situation is similar: you offer an 18 year-old kid a $1000 procedure for free, and he's probably gonna sign up without much in the way of second thoughts.

Like most big government agencies, the DoD had a very hard time looking at itself critically.

MAJ Erik J. Rupard, MD
Troop Medical Clinic Staff
Al Asad FOB, Iraq