Science of Refractive Surgery

Ordinarily, when you think of a scientific study, you think of an honest effort to determine the truth. Ideally, science establishes its integrity through careful methodology, through the dispassionate and single-minded pursuit of the truth, regardless of outside economic or social consequences.

Unfortunately, there is often a considerable difference between what is ideal and what is reality: Reading science in refractive surgery often requires one to read "between the lines." You need to know what the refractive surgery industry needs to establish or further its goals, for example, and how it needs to protect itself legally or extend its presence in the marketplace. Honest research does get done, but it tends to get done after the fact, meaning only after a certain number of people have been injured. These individuals, to whom the procedures were marketed as safe and FDA-approved, are unable to collect damages, simply because---nothing was done outside the so-called "standard of care," that is, their doctor didn't do anything that was known to be unsafe at the time of their surgery. Moreover, studies damning a particular surgery tend to receive widespread support only AFTER some alternative procedure becomes available that might replace the revenue lost by discontinuing a risky procedure. As you might imagine, surgeons who have half million dollar investments in their lasers have no incentive to see negative results published. Neither do manufacturers. In fact, the incentive is just the reverse, that is, to suppress negative findings or quietly change course without incurring adverse publicity. Accordingly, honest scientists who seek to publish negative results may suddenly find themselves under considerable pressure from peers.

From the perspective of those who have been injured, the industry has a very poor track record of studying the downside of whatever surgeries it is currently marketing. Injured patients may find themselves left "out in the cold," wondering how in the world their doctors could---ethically, at least---have undertaken any procedure for which the potential for harm was so great. To these individuals, the safety of a surgery is not defined by complication rates alone, but instead by the quality of life impacts and psychological suffering that a failed surgery can produce.