Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
One of the challenges of being in the ahead-of-the-curve business of communicating about advances in medical science is that based on publications and specialized conferences it may seem that a concept like personalized medicine is rapidly advancing, but out in practice it may not be progressing at all. Such is the feeling I got when I read “Genetics, Your Heart and Your Future,” the keynote address by the American College of Cardiology’s CEO, Jack Lewin, MD, at the conference, “New Frontiers in Personalized Medicine: Cardiovascular Research & Clinical Care” held recently at George Washington University.
Lewin reported that in a survey of 154 “cardiovascular professionals” conducted by the ACC, only 7 percent reported that their patients are being treated with personalized medicine and 77 percent saying that personalized medicine is currently having little or no impact on patient treatments for cardiovascular disease. At that, the survey defined personalized medicine as broadly as possible – “The tailoring of medical treatment to the individual characteristics of each patient” including classifying individuals into subpopulations that differ in susceptibility to a particular disease or response to a specific treatment” and “Preventive or therapeutic interventions that can be concentrated on those who will benefit, sparing expense and side effects for those who will not.”
The survey went on to show that in the few patients who were being treated with personalized medicine, it was used in about half of the patients for preventive therapies based on risk, genetic testing and lifestyle modification. Positively, 73 percent of those surveyed thought that personalized medicine would have some level of impact on patient treatment in the next five years, although for the most part, “not a dramatic one.”
Among the reasons cited for the slow adoption of personalized medicine were insufficient patient outcomes data, reimbursement issues (who pays for a genetic test to be administered?) and the lack of physician education on the topic. The cost issue will remain even though the cost of sequencing a personal genome is falling.
We can think that our principal communications challenge is reaching patients, but unless physicians are comfortable and cognizant about new diagnostic and treatment approaches, adoption will continue to lag. What good is the “thousand dollar genome” if doctors don’t know what to do with it?
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