To the observer, medical progress travels a slow and tortuous road.
There are valid reasons for this, of course, primary among them the need to avoid doing harm to patients. The safety nets and filters between research findings and patient care are formidable, and the consequences of their failure profound. One of the anticipated benefits of personalized medicine based on genomics, however, is to greatly speed up the translation process—which currently takes many years if not decades—through more precision and better understanding of biological causes and effects.
So, how well is the medical establishment managing the transition to more genomics in the clinic? The answer, from where I sit at least, is not great. Worse, I fear that it might get much worse if not downright ugly in some ways.
The thought arose after I pounced on an article from the terrific GenomeWeb Daily website. The headline, “U of Chicago Begins 1,200-Patient Feasibility Study for PGx-based Genomic Prescribing System,” indicated the launch of a promising new initiative. As it turned out, however, it topped an article that made me increasingly uncomfortable.
The premise of the feasibility study is fine, actually. U.Chicago’s Center for Personalized Therapeutics is having patients consent to up-front genotyping to help inform their ongoing care, including drug side effects and interactions. Therefore, their doctors don’t need to order lab tests and wait for results before beginning a treatment regimen. Also, the pilot program will test the doctors’ use of the web-based genotyping information delivery portal. They have more than 600 patients enrolled, with a goal of 1,200 total.
OK, it’s not looking at whole genome sequencing like the Brigham and Women's Hospital initiative in Boston or focused disease panels like the U.K.’s NHS, but so far so good. And then it gets a little odd. The study is just looking at the information infrastructure, not patient outcomes. According to Mark Ratain, the director of the center, “The first question is, 'Can we even get physicians to go to the portal to look up information on their patients?’” Yikes, especially given that the initial group of 13 physicians were selected for being motivated about genotyping.
Also, because of “technical issues,” it’s not integrated with the patients’ electronic health record data, making the portal a standalone one-off dependent on physician’s assistants for data entry. Hmmm, that sounds ominous. But what set me off was that the study, which already seems limited and timid in this day and age, will collect data through 2016. 2016! The study will run for nearly four years just to see if doctors will actually use a portal to look up simple patient genotyping data? Really? I’d be astonished if whole genome sequencing AND analysis isn’t pretty darn clinically useful and accessible by then.
This isn’t meant to call out the University of Chicago medical system, which I’m sure is excellent within the current medical paradigm. It’s just that their pilot project is the latest of many examples I’ve seen recently of highly regarded, prestigious and well-known clinicians and medical institutions downplaying genomic medicine. In general they argue that it’s not ready for prime-time and likely won’t be for a very long time. I’ll grant the first point but am troubled by the second, because they put the advent of progress within the current framework. The whole issue is that it won’t work within the current framework. Thought leaders like Eric Topol and Lee Hood make the point constantly: faster progress is coming if, and only if, the current system can be replaced with one that takes full advantage of the newly obtainable data and understanding.
They will have to keep making that point, because between the speed of research progress and the entrenchment of our glacial medical system, I see a train wreck coming. Everything in the system from the FDA to insurance companies to hospital groups to the doctors themselves will drag their heels through a combination of self-interest and fear of change. Technology will soon far outstrip our ability to deliver its benefits. Patients will be frustrated by therapies that cannot be delivered to the specific patient groups who will benefit because of outdated population-based thinking. Doctors will be ignoring data from simple patient genotyping while sequencing data piles up and gains importance and meaning. And on and on.
How can positive change be effected? Dr. Topol argues that the solution is for patients to drive change for their own ultimate benefit, as it won’t come from within the establishment. It’s an interesting thought, and if it begins to pan out it will fundamentally change not only the system but the doctor-patient relationship itself. Others are trying to work more within the system, with varying results. And some healthcare institutions that tend to be ahead of the curve--the Mayo Clinic comes to mind--are forging ahead with genomics on their own.
As for me, I expect I’ll be an ornery patient if I need significant medical care over the next few years! And I’ll keep reading and writing. I don’t want to see a train wreck. I want to see better patient care.