Research Ethics Blog

This isn’t a research ethics story per se – but a fascinating story about some exciting research that highlights a few important things that researchers, research ethics board members and the public often forget.

Here’s the story, from the New York Times: A Race in Cardiology

A race is on to develop the potentially next big thing in heart surgery: a replacement valve that can be implanted through thin tubes known as catheters rather than by traditional open-heart surgery.

The contest pits two major companies, Edwards Lifesciences and Medtronic. Analysts estimate a market for the product that could exceed $1.5 billion within six years. But if the valves catch on, their benefits for the nation’s aging population could be substantial — even if the impact on the nation’s health care bill may be hard to calculate.

The new valves — which make it possible to repair the heart without the rigors of chest-opening surgery — have been available in Europe for about 18 months, with sales of about $100 million split about evenly last year between the two companies. While doctors say that the early results have been promising, they add that it is too early to gauge the technology’s long-term benefits.

In the United States, the devices are currently being tested in older, critically ill patients in clinical trials. Many medical experts and financial analysts predict that if the devices live up to their makers’ claims, they could revolutionize valve replacement, a common heart operation, and extend the lives of thousands of frail patients who are not now considered candidates for surgery.

In addition to my own fascination with cardiac medicine and surgery from my previous career as a cardiac surgery nurse, I found that this story reminded me, as I said above, about a few things we tend to forget about.

First, industry isn’t all bad. It’s awfully trendy to, in a knee-jerk way, resent big corporations. Yet here is an example (and there are many) of multi-billion dollar corporations who are the only ones who can and will fund research like this. Of course, I’m not naïve — I do realize that there are huge potential future profits for whichever company perfects the valve that allows for minimally invasive cardiac valve replacement. But it’s important to realize that while corporations must aim for profit, they can and sometimes do so through support of technologies like this one, that offers hope to many and helps to revolutionize health care. Without collaborative relationships between corporations, research ethics boards, clinicians and researchers, this kind of research simply wouldn’t be possible.

Second, it’s necessary to respond to changing technology in health care and the only way to do so is through research — sound, ethical research. It’s up to us, as research ethics boards, to recognize potential benefits and the possible fecundity of those benefits. It’s also up to researchers to clearly articulate potential benefits alongside risks. As research ethics board members, we tend to focus on risks. We do (and must) attend to potential benefits, but often not on their own. We need to always view benefits as they are weighed against potential risks. However, when reading a story like this, it does make one pause for a moment. Making minimally invasive cardiac valve replacement surgery an option really does mean that the procedure could be available for many patients who would otherwise be deemed inoperable. It would open the doors for more and more minimally invasive procedures (coronary bypass surgeries and angioplasties can be done in a minimally invasive manner) that reduce risks of surgery and allow surgery to be carried out on more potential patients than ever before. Don’t get me wrong — I’m certainly not saying here that research like this shouldn’t be very carefully reviewed and monitored with a thorough risk-benefit analysis but it’s also okay to sometimes say, “Wow, wouldn’t this be great if it really did live up to its potential!” Having read probably thousands of research ethics protocols by now, I’d like to think I could still get excited about possibilities like this — despite all the skeptics waving red flags at me about big corporations and profit and ompetition and risk.

As research ethics board members, we tend to be inundated with negative stories that are often fraught with problems, wrongdoing and concerns. Realistically, it is our job to look at research with a critical eye. Nevertheless, this story reminds me of the excitement, the possibility, and promise of research, and why it’s so satisfying to be a collaborative and integral part of the facilitation of research.

~ by Nancy Walton on October 1, 2009.

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