Nearly 10 years after the first excimer laser was approved for use in LASIK, and more like 15 years since LASIK was commercially available, I must confess I am finding it difficult to extract from my heart the requisite gratitude for the letter the FDA recently sent to eyecare professionals.
Letter from the FDA to eyecare professionals (May 22, 2009)
The FDA believes that eliminating deceptive or misleading health-related advertising claims is an important part of protecting the public health.
Gosh. I'm so inspired.
Am I glad they sent it? Surely. Do I wish they had at some point in the last ten years? Even more surely.
Several years ago in London I participated in a meeting of a small panel of ophthalmologists and consumers presenting information to two MPs. A great deal of the discussion and presentations surrounded advertising abuses and inappropriate commercial practices of refractive surgery centers in the UK. This was all in the wake of an article published in Health Which? (a consumer magazine) about the negatives of LASIK.
There were a couple of remarkable aspects of the meeting and the process which followed - aspects which I despair of seeing ever mirrored on this side of the Atlantic.
One, ophthalmologists were voluntarily involved and were quite candid in exposing wrongs in the industry. True, their self-interest was very much involved. They were the most highly regarded surgeons in and around London and it would be in their interest to distinguish themselves from the cut-rate chains (the intended distinction, apparently, being between high-calibre medical professionals and simple businesses). It would also behoove them to have some input, rather than no input, into any resulting legislation.
Two, advertising by lasik centers was absolutely hammered by all presenters except (naturally) the one representing a chain - and he was forced to concede by the end of the meeting that some changes were perhaps needed.
Three, the legislators were truly engaged and made sure it did not stop there. A working group was put together and in due course a bill for regulating the industry was introduced to Parliament. Did it get anywhere? Ultimately, no, but it did go through three readings, and in the process contributed quite a lot to public awareness. Hopefully, that was helpful in making consumers cautious before leaping into surgery without a proper understanding of its risks and benefits.
Can you imagine any of those things happening here?
Can you imagine some of the top refractive surgeons in the US sitting down with a couple of congressmen and some consumers?
Can you imagine them candidly discussing industry problems, presenting eggregious examples, and proposing solutions?
No, instead, in April 2008 we were treated to a polished sales pitch for the excellent state of the LASIK industry. They even paraded before us badly disabled people giving testimonials to the personal benefits they had experienced from LASIK. Their callous oblivion and evident disregard for the real-life impact of current incidence of complications and poor outcomes (the which complications and outcomes are documented thoroughly in the profession's own literature), with dry eye at the top of the list, greatly shocked me.
A little over a year has gone by since that meeting and even now reflecting on it it's hard to stop the emotions from rising. There are many things for which I am grateful. I am grateful for the conscientious ophthalmologists that I know. I am grateful for the ophthalmologists and optometrists who dedicate time from their practice to help those of us with short or long term complications.
And I suppose I ought to be grateful even for a letter from the FDA to doctors suggesting they obey advertising laws, after many years of rather blatant disregard for such laws. But, alas....
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