Dr. Weiss Goes to Washington

Meet one ophthalmologist whose powerful voice within the FDA helps bring new devices to the fore in patient care.

Perhaps you know Jayne S. Weiss, MD. She is professor of ophthalmology and pathology and director of refractive surgery at Kresge Eye Institute at Wayne State University in Detroit, and associate director of the Clear Vision Excimer Laser Center in Farmington Hills, Mich.

Underneath those impressive credentials lies one more. She is chairwoman of the FDA Ophthalmic Devices Panel, making her one of the few ophthalmologists who serve as advisors on panels and committees in Washington, D.C. Advisors such as Dr. Weiss play a key role in determining which drugs, devices and health policies are adopted by the federal government and promulgated to physicians and patients. As adjunct bodies to the FDA, NEI and other organizations, advisory panels provide independent scientific, technical and policy recommendations, and their input is weighed carefully in the decision-making process.

Clearly, Eye M.D. service on these panels is crucial to advancement of the profession. Thus, said Patrick Eddington, Washington representative for the Academy’s Governmental Affairs division, “The Academy’s primary concern is ensuring that we get the largest possible pool of qualified applicants. Unfortunately, this has been a problem in the past several years given the increasing demand on our members’ time. That said, I encourage our physicians to remember that the single most influential position they can be in is that of policy advisor, with the opportunity to shape the future of the profession and the practice of medicine in profound ways for years to come.”

There are reasons aplenty to sidestep service on these panels, including the fail-safe “someone else will do it.” But patients need experts like you—ophthalmologists who bring academic and/or clinical knowledge and experience, and a practical understanding of how the ophthalmic office functions—to ensure that the best drugs, devices and policies are brought to bear in their treatment. Without such members, panels might draft regulations and approve devices that look fine in theory but have little real benefit. And if you look at Dr. Weiss’ experience, you might be surprised by how little time she must commit, the lessons she’s learned and the benefits to her career.

EyeNet: How much time do you spend per year on panel work?

Dr. Weiss: Depending on the number of panel meetings held that year, I spend approximately one to three weeks yearly on panel work. Twenty percent of this time is devoted to reviewing reports and preparing paperwork, and the rest is spent on travel and conducting the meetings.

EyeNet: What is the most important lesson you have learned from your panel work?

Dr. Weiss: That there are two sides to every story.

For the last four years, I have been incredibly impressed with the FDA staff in the division of ophthalmic devices. They have always been very knowledgeable, hardworking and, above all, motivated to move the approval process forward. With this intimate view of the process, I think the system functions well. I have not sympathized with frustrations I hear voiced about the FDA.

Ironically, I recently have seen the FDA approval process from another side, that of the patient. I was exploring clinical trials for my father’s metastatic cancer, which was no longer responsive to the approved regimens. I was told the epothilones [a new drug class] were a promising chemotherapeutic agent. However, further investigation showed that my father had exclusion criteria listed on the two available clinical trials for this non-FDA approved agent. Consequently, he could not obtain the drug unless it eventually received FDA approval, which could take years. This issue, of course, is totally unrelated to ophthalmology or ophthalmic devices but is related in general to FDA approval. I understand firsthand the emotion of wanting things to move more quickly, especially for a patient who has few options and is only interested in obtaining treatment regardless of documented safety or efficacy.

From my work on the panel, I understand the approval process must follow specific laws voted on by Congress. Many other countries respect the results of our FDA approval process and use it as the gold standard. I have observed the division of ophthalmic devices facilitate our laws to move the approval process forward. I truly believe they do an excellent job of ensuring that devices demonstrate reasonable safety and efficacy before they enter the marketplace. Unlike the field of oncology, most of our patients can afford the luxury of the time required for approval.

But, I am more able to see both sides of the discussion on the amount of time and money required for pharmaceuticals or devices to be FDA approved in the United States. It would be wonderful if we could find a way to make the process move more quickly for the benefit of our patients.

EyeNet: How has service on the panel enhanced your career?

Dr. Weiss: My phone calls and emails seem to get answered more quickly! Levity aside, my work with the panel has given me the opportunity to interact with a broad spectrum of excellent people in vision science. This interaction has benefited me in a variety of ways, from increased recruiting for my [NIH] RO1 grant on genetic mapping of Schnyder’s corneal dystrophy, to Academy committee participation.

However, most important, reviewing the actual data from clinical trials has given me a more accurate view of the capabilities and limitations of the technology. I think this fuller understanding derived from the public sessions of the panel [the transcripts are on the Web¹] helps me in my academic endeavors because of my experience in critically evaluating data. Likewise, when teaching ophthalmology residents, I know that they must learn the skills involved in evaluating data and being able to distinguish fact from anecdote.

Right now I am in the process of editing a new Academy Basic and Clinical Science Course book on Refractive Surgery, which will become part of the ophthalmology residency teaching curricula. I want to make sure that the text is factually based like other BCSC series books and clearly conveys the science of refractive surgery. It is important to differentiate between results that have been proven in well-controlled clinical studies vs. information that is postulated but not scientifically proven.