It's Time to Remove the Shackles: Patients With Eye Disease Are Suffering Because of Slow Device Approval

American Academy of Ophthalmology (AAO) 2014

Roger F. Steinert, MD


November 25, 2014

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Hello. This is Dr Roger Steinert, interim dean of the School of Medicine at the University of California, Irvine, and director of the Gavin Herbert Eye Institute.

This is a wrap-up of the American Academy of Ophthalmology (AAO) meeting, albeit different from what we have done in past years with panel discussions of the meeting highlights. This is my personal perspective of the Academy meeting, after giving it about a week to gel in my mind, because I had a very unsettling feeling at the end of the meeting that needs to be expressed. As we head into the next session of Congress, with newly elected officials, maybe we can finally start to make some progress in this area.

I am talking about my impression of the Academy meeting, which is a wonderful meeting, and I love going to it, but why? It is mainly to meet with people who you don't get to see very often, and renew old acquaintances. It is to look at the exhibit floor and get a chance to check out any new devices more easily and efficiently. It is also to learn something new that will improve your practice and your ability to take good care of patients. From an anterior segment surgeon's point of view, the latter objective was fulfilled almost entirely by sessions on techniques and on complication avoidance and management. Loads of sessions were terrific, but I didn't walk away with anything new.

It is a very different feeling from the European Society of Cataract and Refractive Surgeons (ESCRS) meeting that took place in London in September, where there was a lot of new material. At the Academy, if you want to get a taste of the same thing, there is the Sunday session led by Bob Osher, who talks about a lot of exciting, new, innovative devices and techniques and technology, none of which is available in the United States.

You have all heard this before, and we have all complained about this, but I have been thinking that we need to stop complaining and start doing something.

It is increasingly clear that the people at the US Food and Drug Administration (FDA) are doing their jobs (as currently defined) as well as they humanly can.

We can complain about specific exceptions, but by and large these are good people who are doing what they have been told to do, which is their mandate to determine safety and efficacy of drugs and devices. It is the efficacy part that is causing the problems.

None of us would object to a device being subjected to good testing for safety. We don't want to be surprised by problems. The FDA has a hard job to do, and although it is imperfect at best, it is a necessary job.

It is the efficacy side that gets us hung up because of the underlying assumption that doctors can't figure out what is best for their patients. Doctors will do things that are not in the patients' best interests and use devices that don't work. That is by and large not true. There is plenty of evidence over the history of medicine that there are some exceptions to this, and there will be some mistakes along the way, but at the end of the day we do the right thing for our patients.

Even with all the stringent requirements of the FDA, the very specific methods of determining efficacy do not necessarily connect with what really happens after a new device is released.

The FDA, to be fair, is trying to address this with so-called "phase 4" and "postmarket approval studies," which are ongoing monitoring studies. Once new products are released into the hands of general practice, it is not constrained the way that a company might conduct a tightly constructed investigational device exemption (IDE) for premarket approval.

We need to do a much more effective job of getting organized and going to Congress to carve out new legislation that directs how the FDA deals with new technology. If we do that, it will be better for the FDA, better for us, and, most important, better for our patients.

As you look over your election results to see who your senators and representatives are, I urge you to support our main organizations: the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery. Open up your pocketbooks and support the PACs and professional associations with government relations branches so that we can work more constructively and positively with Congress and the FDA to change the balance.

It is inexplicable that we are a decade behind Europe in corneal crosslinking. We have individual renegade studies and pseudostudies going on so that individual practitioners can do crosslinking, but most of us won't go down that road. A virtual generation of patients with keratoconus in the United States is being harmed by not getting access to corneal crosslinking sooner. That is just one example. How about patients with traumatized eyes, loss of iris tissue, and disabling glare, not to mention cosmetic deformities? Really great devices are available virtually everywhere else in the world. We are not getting them anytime soon here in the United States. This has been going on for a long time because of the very high cost of getting approval for a low-volume, low-profit-margin device that we would only use in the best interest of our patients.

These are only a few examples; there are myriads more. We have the world's best medical device industry here, and what do we do? We not only get in the way of devices being available in the United States, we then actually add an oppressive extra tax to help fund healthcare. How does this make any sense? The blame is ours, and it is up to us to connect with the legislature and turn this around before it is too late.

We have the greatest medical support system, medical technology system, and medical care system in the world, despite all the phony statistics. In my opinion, the statistics are phony because nobody has the heterogeneous population or the economic challenges that we have in the United States, so you can't use statistics from these other countries. We have plenty of problems. They need to be addressed and we need to have the technology on our side, and that can only happen if we take some of the shackles off and let the FDA do its proper job of determining safety. They can't do that if we don't work with Congress to enable them to do so.

That is my post-Academy wrap-up. I'm Roger Steinert on behalf of Medscape. I welcome your comments, but let's get out and do something. Thank you.


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