Guest Editorial

Has the US Lost its Edge in Innovation?

By Alan B. Aker, MD

The frustration I feel as a US surgeon is at the forefront of my thoughts whenever I visit with colleagues in Europe or attend the ESCRS meeting. It's obvious that our international colleagues have at their disposal innovative new lasers and a wide array of next-generation IOLs that we simply do not have available for our patients in the US.

This frustration has grown out of visits my wife and I have made with colleagues we know in Europe, and discussions we've had with them regarding the challenge of meeting the expectations of patients receiving premium IOLs. Patients have a right, especially after paying a premium fee, to expect a premium outcome. In that regard, even after we've explained to a patient that we might have to “tweak” their refraction after the initial surgery, we are often challenged by what is required to achieve emmetropia.

Premium Price, Inferior Options

Let's consider a disappointed premium IOL patient with a postoperative refraction of +1.25-0.75x45. There are a number of things US surgeons can consider to fine-tune this outcome. We can offer them LASIK or a limbal relaxing incision, but both procedures have drawbacks and lack the desired precision. If we perform an LRI, the patient will still be left with an undesirable hyperopic outcome.

Should we consider a piggyback? Perhaps. But in so doing, we now find ourselves using an IOL that was designed for primary implantation in the capsular bag of a high myope, rather than in the sulcus. Essentially, we are using that IOL in an off-label use as a less-than-optimal solution for this postoperative outcome.

This is routinely done in the US, and, for that reason, we sometimes see patients with these piggybacks with significant iris chafing and loss of iris pigment. This unwanted loss of pigment comes from contact with the posterior iris and the less-than-optimal IOL design for this purpose. Beyond their design deficiencies, these low-power IOLs were planned for high myopes and are available only in whole-diopter steps rather than the more desirable quarter- or half-diopter steps. And all this doesn't even begin to address the incorporation of astigmatic correction in these same IOLs.

This is extremely frustrating when we see how easily these challenges are addressed by our colleagues in the UK or throughout western Europe. For patients like our example patient described above, our European colleagues simply order an “add on” or supplementary IOL to meet the spherical and astigmatic needs of their patient. And the lens they order is designed for sulcus placement as a supplementary IOL, thereby eliminating the likelihood of iris chafing, iris-optic capture, inter-lenticular opacities and poor centration — all seen with current piggybacks used by US surgeons.

The bottom line: in other countries, the patient gets the premium result for which a premium fee was paid. The patient also has a safer and better “fix” rather than what we are able to offer in the US. Certainly, using a LASIK procedure to tweak the outcomes of premium IOL patients is an option, but in many of these patients dry eye and other corneal issues pose real concerns. PRK is a cumbersome alternative, but certainly the ease of the European option for supplementary IOLs is the more desirable approach for patients here in the US as it is “across the pond.”

Losing Our Competitive Edge

This small example is but one symptom of a much larger problem. The United States, the traditional leader in new technology in most fields of endeavor, has now become the land of the Have-Nots. We look longingly at those who Have — namely, our European colleagues with unfettered access to a whole array of products to enhance the vision of their patients.

The Old World gets all the newest products these days. Let's consider just a few options denied here “in the colonies.” The Light Adjustable lens (Calhoun), the Synchrony accommodative IOL (AMO), the Restor multifocal toric (Alcon), the Acrysof Cachet phakic IOL (Alcon), the Sulcoflex multifocal toric (Rayner), the enVista hydrophobic IOL (Bausch + Lomb), and the AT Lisa multifocal IOL (Zeiss) are but a handful of innovative lenses that international patients are benefiting from while ours must do without. As you peruse the exhibit hall at this month's ASCRS, you will no doubt encounter even more forbidden fruit.

Why are we the land of the Have-Nots? It might have something to do with the difference in how new products are approved for commercial use in Europe and in the US. We are all familiar with the important work of the FDA and how its approval validates a product to be safe and effective — goals shared by all surgeons the world over. In Europe, the CE mark is the comparable designation of safety.

I shared my frustration recently with a West Point classmate who practices law in Florida. After flying helicopters in Vietnam, he went on to fly both corporate and commercial jets. As a result of his interest in aviation and his knowledge of the law, he was puzzled by this seeming ophthalmic disconnect between Europe and the US. He looked at the issue of airworthiness of an aircraft. If an aircraft made by Airbus is deemed airworthy for Europe, it is automatically deemed airworthy for the US.

Why, he asked, can't US citizens have access to IOLs deemed safe for implantation in Europe? It's a sound question and appropriate for our time. We live in a global age, but this disconnect seems to plunge us back to the days when we needed an overseas operator to place a call to Europe.

A modest proposal would be to modify the approval process. Why can't products currently being safely used by our colleagues in Europe also be used by US ophthalmic surgeons?

The losers at present are US surgeons and our patients. But companies that develop and manufacture ophthalmic technology also suffer. Because of the almost prohibitive costs needed to sustain an FDA approval process, many technologies will take years to make it to our shores, if they make it at all. Some companies are forced to make the hard-nosed business decision to simply opt out of the US market, after they sized up the return on investment and found it wanting. “Why bother?” they ask. Why, indeed.

Perhaps it is time to revisit the difference between the European approval process and the FDA with an eye to eliminating duplication of cost and effort. The US once led the world in medical device innovation. We can again, if we are able to reform a regulatory system that has become obstructive and counterproductive rather than supportive of cutting-edge patient care. As the saying goes, “We have met the enemy, and he is us.” OM

Alan B. Aker, MD, is co-founder and Medical Director of the Aker Kasten Eye Center in Boca Raton, Fla., and a noted author on refractive cataract surgery and advanced technology IOLs. Contact him at akeraba@gmail.com.