DEC 2012

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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February 2011 December 2012 Innovation: A look ahead to work with the leading ophthalmic companies.��� Gone are the days when companies paid substantial fees to physicians, Dr. Hovanesian said. ���The amount of time and research teaching physicians put into developing lectures and podium presentations is far beyond the small amounts that are paid as honoraria,��� he said. Dr. Lindstrom agreed that if physicians consult with industry, ���they���re going to be paid less than if they stayed home and saw patients in their practice,��� and they also should have thoroughly read and agreed to PhRMA���s Advanced Code of Conduct, as there is increasing risk for the consulting ophthalmologist. Physicians ���want to be educated in a way that raises the level of care,��� Dr. Hovanesian said. ���We don���t mind being measured to see how that education affects our thinking,��� but do not want a ���commercial message when we go to a continuing medical education event.��� Being educated about the entire disease state ���is an important way education is going to change the physician-industry relationship,��� Dr. Hovanesian said. Dr. Waring founded an ocular biomechanics laboratory where he can carry out translational research within the department of bioengineering. (For more, see sidebar.) ���You���ll see these type of translational research labs pop up more and more in the U.S. in both academic centers and increasingly so in the private sector, where they���ll be Outside the box Ophthalmic ���think tanks��� are popping up with regularity in an attempt to foster innovation without oversight V enture capitalists typically follow the innovators���no product can come to market without signi���cant investment behind it. But the risk of non-approval in the U.S. ���is so much greater, and the path to reward is so much longer that companies are rarely investing in the medical space these days. They���re being incredibly choosy because they have to be,��� Dr. Hovanesian said. In response to the overregulation by the FDA, ���we���ve been forced to ���gure out ways to develop new technologies and innovate in this culture, and it���s very different. It still happens, but it���s so much more complex,��� Dr. Waring said, and that���s why alliances formed outside the U.S. are growing, as is the use of translational labs. Cloud-based data exchange ���will globalize innovation,��� he said. Along those lines, Dr. Waring said these ���microincubators��� of innovation will become more commonplace ���not only given regulatory climate but in an event to push industry and to help industry grow.��� Cirle, a medical technology incubator, based in Miami, and founded by Richard Awdeh, M.D., is one example of a partnership between industry (Bausch + Lomb, Rochester, N.Y.) and academia (Bascom Palmer). Cirle is currently ���building a small, highperformance team of biomedical and chemical engineers, along with staff scientists, to pursue research and product development initiatives,��� according to a news release. The mission of Accelerated Vision Group (Overland Park, Kan.) is to ���provide a comprehensive suite of world class and technologically advanced business intelligence products and services tailored to the global ophthalmology industry,��� according to the website. A third, Strathspey Crown (Strathspey, Scotland), positions itself as ���a lifestyle healthcare-focused growth equity ���rm ��� Strathspey Crown uniquely partner[s] with specialty physicians to build highly innovative lifestyle healthcare technologies and services that provide life enhancement and wellness to patients worldwide.��� ���Innovation is such a signi���cant part of our specialty,��� Dr. Waring expects these types of private partnerships and translational labs will become standard in the near future ���as we continue to develop innovative ways to innovate.��� run efficiently like businesses,��� he said. Dr. Lindstrom also suggested colleagues get to know their state and federal representatives and educate those in government about how the current regulatory environment is impacting medical innovation and advocate for constructive change. Industry���s role The relationship between industry and physicians must ���advance science and promote knowledge and education and advance new discoveries without breaching the public trust,��� Dr. Lindstrom said. ���We need to do things in a fashion whereby the public continues to trust the medical profession.��� Physicians in Minnesota have consulting relationships published in their local papers at least once a year, per the state���s Sunshine Act. Most of Dr. Lindstrom���s patients and colleagues are surprised by the small stipends. ���Most of us who are in a position to do this kind of consulting can make a lot more money in a busy surgical practice than we can by consulting with industry because the guidelines are pretty stiff regarding the hourly rate,��� he said. More industry-specific ���microincubators or think tanks are going to spring up,��� Dr. Waring said. ���The U.S. will continue to play a vital role���regulatory approval in the U.S. often leads to a sort of acceptance by the global scientific community,��� Dr. Waring said, presenting a bit of a conundrum for companies that choose to ignore the U.S. market because ���it���s not worth going through the FDA process.��� The regulatory environment ���has to change. Industry needs to look to physicians for guidance for what products are best to serve our patient population. We need to be asked, and our input needs to be welcomed,��� Dr. Hovanesian said. ���You can regulate the interaction between physicians and industry, but they definitely shouldn���t try to reduce it��� any more than it has been. What needs to change Simply put, the federal government needs to make it easier for companies to get drugs and devices approved without spending as much EW FEATURE 31 as they currently are to do so, Dr. Hovanesian said, adding the concept that restricting market access will reduce costs has proven ineffective. ���A lot of what we do now isn���t just about making the widget the most safe and efficacious, but doing it most efficiently in the current regulatory environment,��� Dr. Waring said. Oversight is needed, but ���I���m concerned the pendulum is swinging a little too far,��� Dr. Lindstrom said. The environment has created a situation where ���if working with industry is perceived as too much of a negative, people will just stop doing it,��� he said. Conducting research and reporting on it ���can���t become so onerous that doctors don���t have an interest to participate any longer,��� he said. ���That would be devastating to the innovation cycle in America.��� The rami���cations of inaction ���The trajectory of overregulation by the FDA is not sustainable from this standpoint,��� Dr. Waring said. Dr. Hovanesian predicts that if the regulatory environment remains as is, more and more innovative ideas that are being generated in the U.S. will be evaluated overseas. ���It���s a domino effect���products invented here are approved elsewhere but not used until they���re approved in the U.S. We may be the world leader in innovation, but having these regulatory hurdles is just dragging the whole world down,��� Dr. Hovanesian said. ���The world will continue to innovate. The products are just not going to be developed here, and the U.S. will soon lose its role as the leading innovative country in the world,��� Dr. Hovanesian said. EW Editors��� note: Dr. Hovanesian consults for industry. Dr. Lindstrom consults for industry, including Abbott Medical Optics (Santa Ana, Calif.), Alcon (Fort Worth, Texas), and Bausch + Lomb. Dr. Waring consults for industry. Contact information Hovanesian: 949-951-2020, jhovanesian@harvardeye.com Lindstrom: 952-567-6051, rllindstrom@mneye.com Waring: 843-876-1650, waringg@musc.edu

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