Ilove lists. What is the greatest rock and roll song of all time, the biggest sports upset ever, and the best ice cream flavor? My answers are “Stairway to Heaven,” the 1980 US Olympic hockey team's triumph over the Soviet Union's, and mint chocolate chip. This issue of Cataract & Refractive Surgery Today celebrates the best of 2010. Leading surgeons identify the innovations, techniques, and technologies that are changing how we practice ophthalmology and improve the quality of care we provide to our patients. Now, that is an important list.
The year 2010 may be one of the most exciting that I can recall in terms of innovation. A decade from now, I believe it will be defined as the year that laser cataract surgery was introduced, but it could also be known as the year microinvasive glaucoma devices received panel approval at the FDA and began to change the way we control IOP. Phaco technology and the formation of the LASIK flap with a femtosecond laser both improved, and 2010 ushered in or saw wider adoption of new antibiotics and antihistamines, an antiviral agent, a nonsteroidal drug, and a potent corticosteroid.
Innovation is the lifeblood of medicine, and ours is a technology-driven specialty. My greatest concern for the future of medicine and ophthalmology in particular regards the current challenges to innovation. The cost of health care has spiraled out of control, and the United States recently provided coverage for an additional 30 million uninsured people. The US government favors the populist, socialized solution of mandating that all citizens be entitled to the same level of health care and that those willing to pay for new technology be denied the opportunity. Not allowing people access to new technology strangles innovation and will eventually move US medical care toward mediocrity.
Another factor is the FDA, which has become tremendously averse to risk. Device manufacturers are leaving the United States to perform their studies abroad where regulation is more reasonable. The cost of performing FDA trials has skyrocketed. Recently and, as far as I know, for the first time, an ophthalmic pharmaceutical developed in the United States was rejected here but approved in Japan. The FDA appears to be chiefly concerned with impelling pharmaceutical manufacturers to market only FDA-approved indications for their products. Allergan, Inc., was recently fined $600 million for marketing Botox for migraines, because it was not approved for this indication, although millions of migraine sufferers might benefit from this treatment. Then, a couple of weeks later, the FDA approved the migraine indication. More important is that, as part of the settlement, the FDA forced Allergan to drop its lawsuit against the agency that contended marketing off-label indications is freedom of speech. The off-label use of medications is common and often the standard of care. The FDA must do a better job of balancing its duty to protect the American consumer with its role of approving new and improved drugs and devices in a timely fashion.
To close, I would like to wish all of CRSToday's readers a happy new year. Despite my grumblings, my essential optimism predicts that 2011 will be even better than 2010. It is easy to be content with the status quo. I love reading CRSToday, because the authors challenge me to improve my care of patients and my surgical outcomes. I invite readers to join me in that quest.