Eyeworld Supplements

LEADING A REVOLUTION 18 | SUPPLEMENT TO EYEWORLD ere was, however, a consumer group, led by Ralph Nader and Sidney Wolfe, MD, that didn't like the results of the study and "wanted a study to study the study, and the FDA concurred," Henry Clayman, MD, said in an ASCRS video. e regulations, the study, and IOL animosity came to a head in early 1980. As a January 8, 1980, article in the Washington Post described, some, including the FDA's commissioner at the time, thought more research was needed to determine the safety of IOLs while "doc- tor aer doctor … testified for the use of the lenses." In recalling this pivotal moment, many ASCRS mem- bers say a key Senate testimony did not come from a doctor, at least not a real one. It was well-respected ac- tor Robert Young, who played Marcus Welby, MD, on the popular eponymous television show. e Washing- ton Post reported at the time that Mr. Young, age 72, received intraocular lenses as part of his cataract sur- gery performed by Richard Kratz, MD. He called the implants a "miraculous medical breakthrough" that al- lowed him "to see and work again." From there, Dr. Kratz recalled in the 25th ASCRS an- niversary publication, "e Senate Committee decided if it was good enough for Dr. Welby, it was good enough for the country." Mr. Young's testimony received national media cov- erage as it ushered in an era of government oversight of the medical device industry. e new device bill was written so that IOLs would "be made reasonably avail- able to physicians," even while they were mandated to be studied. IOLs were granted an investigational device exemption effective 1978, which required every surgeon using implants to be approved as an investigator. From 1978–1980, more than 170,000 IOLs were implanted under the investigational device exemption. Under the supervision of Robert Drews, MD, he and Dr. Hoffer helped prepare the membership and helped the FDA create the forms to be filled out for the IOL studies, making them acceptable to clinicians. Dr. Hoffer speculated that if IOLs had been more heavily regulated at the time, smaller studies would have been conducted and it could have delayed IOL innova- tion and implantation for a decade. Dr. Masket said that while surgeons as of 1978 were allowed to use implants with an investigational device exemption, it was only within tightly controlled studies. He said there was a core investigation for every new lens where you had to achieve a certain level of vision (cor- rected and uncorrected) and have complications under a certain benchmark. " I know it was onerous, but I think the FDA did a very good job because we have products now that we know are safe and effective." —SAMUEL MASKET, MD An excerpt om the testimony of actor Robert Young, aka Marcus Welby, MD "I have traveled across the country for this hearing today because a few years ago my career was saved and the overall quality of my life was significantly improved when I had intraocular lenses implanted, first in one eye and later in the other, following cataract surgery. is amazing medical device has done much to help me function better and enjoy life more. So I must implore you not to take any action that could frustrate the continued development of intraocular lenses." Mr. Young spoke in defense of IOLs. Source: ASCRS

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