Eyeworld

EW NEWS & OPINION 12 September 2014 by David F. Chang, MD 1980: Oren Hatch and IOLs Henry Clayman, MD, and Randall Olson, MD Dr. Clayman: For reasons that I still do not understand, the introduc- tion of IOLs into clinical practice invoked the opposition of Ralph Nader's medical group, headed by Sidney Wolfe, MD. I went to numerous FDA hearings in Wash- ington, representing AIOIS. The FDA commissioned a study of IOLs that was favorable. However, this did not sit well with the Nader group, who persuaded the FDA to commission a study to study the study. Dr. Olson: Dr. Kratz previously described how IOLs had been saved at the 1980 public FDA hearing by Robert Young. However, immediate- ly after this, IOLs remained in a state of limbo called "adjunct status" by the FDA. This meant they were still offi cially experimental, and there was burdensome paperwork asso- ciated with their use as part of this study. Furthermore, in spite of years of use and acceptance, all patients had to be told this was still exper- imental and not FDA approved. Enemies of IOLs, and there were many, loved it, and the increasing numbers of surgeons using these devices hated it. and said: "OK, let's get this done." Henry called a little later and said the logjam had cleared. IOLs were getting approved plus a pathway was clearing to allow new IOLs to get approved in the future. He credited Sen. Hatch's direct intervention. Dr. Clayman: Sen. Hatch was recep- tive to our position, and the support accorded by Randy helped tremen- dously. The rest is as described by Randy, and it is true that the root beer fl owed freely that night in Provo! Just what the Senator said to the FDA I don't know, but thanks to his strong advocacy, IOLs soon after became the standard of care. 2005: Christopher Cox and premium IOLs Andy Corley Frustration was starting to set in. After 4 and a half years of making the argument that patients should have a choice in upgrading their intraocular lens, we had made little progress. We had met at the highest levels of CMS (then known as the Health Care Financing Administra- tion) repeatedly making the case for patient choice. Prior to those meetings, we had considered and dealt with all of the legal and fi nan- cial aspects. We analyzed the policy issues from all angles and from the standpoint of every constituency. We had tapped the expertise of the most talented attorneys and consul- tants. Yet nothing changed. Finally, essentially out of total frustration, our team went to see Chris Cox, our local Congressman (R-Newport Beach, Calif.). Members of our team were experienced in working with our local offi cials, but none of them had worked with Rep. Cox. Our team thought the visit with the Congressman would make the Eyeonics board feel better but wouldn't really change anything. I had been warned by our team of experienced politicos to expect the glad hand, some political chitchat, and then [be sent] out the door with a sympathetic representative—after which nothing would happen. What actually followed was quite different. When we entered, Rep. Cox was working at a stand-up desk. He had broken his back in a Jeep accident in his 20s, and this was his long-term therapy. We were greeted warmly, Dr. Clayman: At this point I decided we needed a higher authority, and I asked Randy Olson if he could get me access to Senator Orrin Hatch of Utah. Dr. Olson: Henry Clayman called me to tell me that the FDA was going to continue the adjunct status indefi - nitely, just when many had hoped that at least a few IOLs were going to be offi cially approved. That meant there was no clear path to approval, and besides the never-ending state of adjunct status, this was a major impediment to any new technology getting into the marketplace. He asked if I knew Sen. Hatch, who had the reputation of being someone who was unafraid to take on the FDA. I said I did and would help arrange a meeting. Henry let it be known that this was an issue of "the sooner the better." At this time, the Donny and Marie Osmond Show was a big hit and was being fi lmed at the Osmond studies in Provo, Utah. It turned out that the Senator and his staff were visiting there in a few days, and they agreed to meet with us if this could be arranged. Henry dropped every- thing and fl ew out. I picked him up at the airport and we drove to Provo. We got to the studios, and Henry has always joked that he never saw so much root beer consumed in his life. We did not have to wait long, and Henry was allowed to make his pitch to the Senator and staff. Henry was fi red up and gave an eloquent speech about what had happened and how this state of limbo was never going to end unless someone stepped in and brought reason to the fore. Dr. Clayman: I explained to him what an IOL was and why it was advantageous to patients over the alternatives, principally aphakic glasses. I further explained that the FDA's position was incomprehensi- ble and an impediment to the well being of the public, usually the elderly public. Dr. Olson: Sen. Hatch asked a few questions and turned to me. As I recall, he said: "Randy, if I am going to stick my neck out here, is there anything else I should know, and do you agree with everything that has been said?" I agreed that Henry was spot on and that we really needed his help. He turned to his staffers It never hurts to have friends in high places I n my May 2014 column, Richard Kratz, MD, told the amazing true story of how Robert Young, the television actor who portrayed Marcus Welby, MD, literally saved IOLs in the U.S. when his impromp- tu comments outside the hearing room during a pivotal FDA hearing were aired on national television. However, although this prevented the FDA from being able to ban IOL implantation at that time, this was but a single disaster-averting victory in a very long war. The FDA still imposed numerous regulations that effectively served as obsta- cles to IOL development, use, and adoption. Few ophthalmologists appreciate how the last major barrier to IOL access was in essence removed through the efforts of Senator Orrin Hatch. Henry Clayman, MD, government relations chair and later pres- ident of the American Intra-Ocular Implant Society (AIOIS, the predecessor of ASCRS), and Randy Olson, MD, newly appointed chair of ophthalmology at the University of Utah, were able to convince Sen. Hatch to advocate on behalf of IOLs with the FDA. Arguably the second most important regulatory victory came 25 years later with the 2005 CMS ruling permitting patients to pay the additional costs for refractive IOLs. We owe much to Andy Corley (Eyeonics CEO at the time) and his team for navigating the political and regulatory gauntlet necessary to achieve this landmark ruling. Few gave them any hope of success. However, as Andy writes here, this would have never been accomplished without the strong personal advocacy of Congressman Christopher Cox. This month, the ASCRS Government Relations Committee, under chairman Brock Bakewell, MD, has prepared a summary of key legislative priorities for our readers and members. These were some of the issues highlighted during the Alliance of Specialty Medicine's Legislative Fly-In, where ASCRS members met with their rep- resentatives on Capitol Hill. So many of us tend to dismiss the notion of meeting with legislators because of apathy, cynicism, or lack of time. However, these 2 key historical events—that forever changed the practice of IOL surgery—remind us of the impor- tance and necessity of political advocacy for the medical profession. David F. Chang, MD, chief medical editor continued on page 15 Henry Clayman, MD Randall Olson, MD Chief medical editor's corner of the world

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