Are we no longer a nation built upon risk?

September 1, 2005

At a recent meeting of department directors, the president of my university, William Brody, MD, PhD, made an offhand comment that resonated with me. He noted that "the citizens of the United States, a nation built upon risk, seem no longer willing to accept any risk."

At a recent meeting of department directors, the president of my university, William Brody, MD, PhD, made an offhand comment that resonated with me. He noted that "the citizens of the United States, a nation built upon risk, seem no longer willing to accept any risk."

Reading the newspapers and watching television news convinces me of the accuracy of this observation.

In the early days of this country, people took calculated risks all the time. Pioneers braved dangers (frequently running out of food, perishing in attacks by hostile Native Americans, succumbing to disease-to name a few) while searching for a place to farm and create a better life. A large percentage never made it.

Today, our society seems to believe there should be no risks; the corollary of this belief is that if something untoward occurs, someone must be forced to pay. If an American becomes obese from gorging on fatty foods and failing to exercise, the restaurant chain is dragged into court. If a child falls off a swing at the park and hurts him or herself, the city must pay.

In a previous town where I lived in California, city parks were actually being closed because the city could no longer obtain insurance against playground lawsuits.

Perhaps recently you saw that the U.S. government is being sued for allegedly failing to give warning to tsunami victims half a world away.

What is the point of this rant, you may ask? The point is that this aversion to risk will have, and already is having, a dramatic impact on medicine, and very much for the worse.

If a carefully studied and FDA-approved drug is found to have a previously unknown side-effect, an outraged public races to the courtroom, companies literally risk being sued out of existence, and our newspapers denounce the FDA as corrupt or incompetent. Yes, we want pain relievers, but we want them to be absolutely free of risk. Only one state, Michigan, grants protection from lawsuits for a manufacturer who is selling an FDA-approved medication.

U.S. device manufacturers now routinely test new technologies outside our borders, often in so-called third-world countries (Mexico, The Dominican Republic, etc.). My observation is companies often seek to gain extensive experience in the less litigious world before daring to begin clinical trials in the United States. Some drugs, routinely used outside the United States, are not even available in the United States, because it makes no sense for companies to spend hundreds of millions to do all the studies required to prove safety and efficacy, and take the risk of liability suits. As a corneal specialist, for example, I would love to have acyclovir ointment for my patients with herpetic keratitis. Mexican and European patients can have it, but mine cannot.

Could IOLs have been developed in today's United States? The first IOLs were plagued with problems (corneal decompensation, cystoid macular edema, glaucoma). The wonderful foldable posterior chamber IOLs we enjoy today took decades to emerge.

In those early days with less-than-perfect IOLs, we just took care of the problems, removing IOLs and performing penetrating keratoplasties as necessary. Today, my fear is that those companies would be sued out of existence.

We just recently lost the brilliant innovator, Charles Kelman. Did you know that his first phacoemulsification patient, in Charlie's words, "had an eye full of pus" on postoperative day one? The early phaco devices broke down a lot. They were much less efficient than what we have today, and therefore a lot more energy was required, with attendant problems. If that occurred today, would the work have been allowed to continue, or would lawsuits and the need for "patient protection" have nipped in the bud the revolution that resulted in small-incision cataract surgery?