The Eyes Have It

Armand Rossetti

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AMO, Bausch & Lomb, and other solution manufacturers have been practicing market driven Science. While market driven science is not necessarily bad, if taken to its extreme, it can violate basic Voodoo principles.

The eye is one of the most complex organs in the human body, and one of the few organs that are directly open to the environment. The biology and chemistry that is the eye has evolved over millions of years, and that evolution has resulted in the body's capacity to let the outside world, with all of its chemical and physical uncertainty, come into direct contact with what is otherwise an organ that should not be so exposed.

But the eye is necessarily open and exposed to the outside world, and it has created its own internal environment that allows the eye to coexist with the external environment. Scientists who spend lifetimes studying that environment know just how delicate it is. Those scientists are thoroughly familiar with the biology and chemistry that maintains the eye's equilibrium.

Understanding the eye's delicate equilibrium, responsible scientists should, and many do make every effort to create compatible medicines and devices. Those materials either have to mimic the composition the eye's internal environment, or the world's external environment. Because of those requirements, scientists have to exercise substantial responsibility to ensure that the eye's complex environment is not seriously disturbed.

When formulating pharmaceuticals or devices that are destined to be in contact with the eye for hours, days and months, responsible scientists will consider all of the consequences of their actions. The goal for many is to cause the least environmental disruption possible to accomplish the desired outcome.

Voodoo has been characterized as a barbaric, or primitive practice. No reasonable scientist would ever think of acting as Voodoo Papas or Mamans, leaving scientific investigation and decision making to spirits or Loa that just make things happen. That's something that marketing people would do. To marketers, scientists are the slow moving necessary evil that will give them the edge over the fast moving competition.

However, Voodoo does teach one important lesson: Each thing affects something else. There are sacred cycles. What the scientist produces for the eye will affect the eye. If CEOs with a pure market based mentality enter the realm of scientifically based corporations, such as Bausch & Lomb, or AMO, the pace will quicken, and scientists will be summarily striped of most marketing decision-making authority. In the eyes of the consummate marketer, the strict constructionist, marketing guru, slow decision-making is no decision-making, scientific or otherwise.

With that in mind, what is a reasonable scientist who has to make a living to do?

For example, eye care solution scientists are well aware of the following facts. The FDA has grouped contact lens making materials into four different groups: 1) Low water content nonionic; 2) high water content nonionic; 3) low water content ionic, and 4) high water content ionic. In doing so, the FDA has attempted to classify all lens hydrogel materials into groups, which are believed [not actually proven] to behave the same chemically.

Not to be boring, but to make a point: Group 1 consists of: Crofilcon, Dimefilcon A, Genfilcon A, Helfilcon A & B, Iotrafilcon, Mafilcon, Polymacon, Tefilcon and Tetrafilcon A; Group 2 consists of Alphafilcon A, Altrafilcon, Ofilcon A, Omafilcon A, Scafilcon A, Surfilcon A, Vasurfilcon A and Xylofilcon A; Group 3 consists of Balafilcon A, Bufilcon A, Deltafilcon A, Droxifilcon A, Etafilcon A, Ocufilcon A, and Phemfilcon A; and Group 4 consists of Bufilcon A, Etafilcon A, Focofilcon A, Methafilcon A, B, Ocufilcon B, Ocufilcon C, Ocufilcon D, Ocufilcon E, Perfilcon A, Phemfilcon A Tetrafilcon B and Vifilcon A.

As scientists knowledgeable in the art know well, the only thing these lens chemicals all have in common are the letters "f i l c o n." Some do act chemically like others, but no two are exactly the same. In fact, there is a lens on the market that is not made from any of the above listed materials. CooperVision makes a lens from phosphorylcholine, a substance found naturally in human cell membranes. In fact, phosphorylcholine is secreted by the seminal vesicle. It is not on the FDA list.

Now, you are the lucky chief scientist that comes in contact with a marketing executive that a can do CEO of like marketing knowledge training and experience has empowered. The first words from that executive to reach your ears are, "We have a problem. Alcon has a monopoly on using polyquaternium-1 in its one step solution. We have paid your team good money to come up with an alternative, and all you keep saying is that you need more time to investigate. We do not have that kind of time, because we are losing our market. A lost market means lost jobs...if you get the drift. We need a solution to compete, and we need it yesterday. So, scrap that comprehensive testing crap, and get down to business."

And you respond, "What about my suggestion of making several different solutions that are chemically matched to lens materials?"

Answer: "We don't have the budget. You scientific types just don't understand manufacturing complexities. Several solutions means big bucks, and it's about the bottom line...you're smart enough to realize that, aren't you?"

Dumfounded, and exhausted from repeatedly telling the marketing types why you need to be comprehensive, you sit at your desk and the nightmare replays in your head as you free associate:

"...Ionic, nonionic, high water, low water, filcons, maverick lens material, semen, god, polyquaternium-1, polyquaternium-10, they are really different, I told them that a thousand times, they want slippery, lotus blossom slippery, maybe if I add poloxamer, that's slippery, but how will it react with polyquaternium-10, and even if I discover that in a few months, how will those chemicals react with each of the lens materials on the market, they are all different, ionic, nonionic, the solution will be ionic attached to nonionic, Acuvue Advance incorporates a surfactant right in the lattice of its hydrogel, god I need to test that aspect, to be fair...we need to conduct in vivo clinical studies with all of the lenses on the market. Otherwise, we are going to be playing a biochemical version of Russian Roulette...they won't even consider my suggestion to rub...it's not sexy"

Then the phone rings, and it is the CEO telling you that you must move along, or you will be moving along, if you get the drift. "You take care of your end, and we will deal with FDA. Do the best you can; it's a simple one step solution, not rocket science."

You hang up with the CEO and you suddenly face a dilemma, to produce or leave. So you gaze at the family pictures hanging on the wall in your office and make your decision to be as responsible as you can be, while considering your family responsibilities.

As an experienced solution scientist, there is only one unqualified statement that you can make; There is no way to predict even a fraction of the possibilities for dangerous biological consequences due to unpredicted chemical reactions between the solution components, the different lens materials, and consumers' eyes.

If you plan to stay in the game, you close your eyes, cross your fingers, and hope against all odds that no one will be injured.

One last thing, there is another statement you might have heard from the grapevine of common sense: "One size shoe does not fit all." If that statement is logical enough that shoe manufacturers realize that their assembly lines must accommodate consumers' feet, why does the same logic not apply to eye care solution manufacturers?

In the scheme of things discussed, I think the eyes have it (or maybe, they have had it).