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FDA commissioner: New technologies boosting CV treatments, but evidence must keep pace
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Treatment for patients and improved outcomes for CV diagnoses can be combined with the use of new technologies such as social media while still being strenuously evaluated, according to a recent column published by FDA Commissioner Robert M. Califf, MD, MACC, in the Journal of the American College of Cardiology.
However, Califf wrote, “if we are to harness these technologies and apply them effectively, our systems for evidence generation and health care delivery must continue to improve in concert with drugs, devices and biological products.”
Robert M. Califf
Califf wrote that death from CVD fell 40% in the early 2000s and that new drug and other clinical developments will contribute to an even better future.
“We are now entering a new era in medicine that is characterized by dramatic accelerations in biological and information sciences and near-ubiquitous uptake of social media and personal devices,” Califf wrote. “Together, these advances make possible the integration of complex measurement and decision support with traditional devices, drugs and biologics to produce powerful interventions that can be evaluated much more rigorously and efficiently.”
Califf lauded the CV community as being at the forefront of evidence-based medicine, but urged practitioners to probe further.
“Almost all Americans now have electronic health records, and social media combined with wearable devices are opening new frontiers in patient- and population-level data,” he wrote. “In addition, registries for quality and care delivery are proliferating.”
Califf wrote that medical care will need to be specifically tailored to patients’ life cycles.
“As our knowledge continues to expand, it has become clear that we need to focus on both ends of the lifespan,” he wrote. “Major diseases of neonates and children ... pose special issues, such as how to weigh the benefits and risks of broad preventive efforts in the face of uncertainty. ... Elderly patients ... represent another underserved population. Although many interesting observational studies have been done, we have a real deficit in knowledge pertaining to proper dosing of therapies ... or when invasive procedures are indicated.”
The research landscape must change in tune with technology, Califf wrote.
“Devices including physiological monitors, pacers, cardioverter/defibrillators and stents have been an important part of [CV] medicine’s success,” he wrote. “We now need [CV] specialists and major institutions with expertise to join together to create effective networks for conducting early device feasibility studies.”
He also wrote that “the FDA welcomes collaborative work aimed at” addressing demographic disparities in lifespan and quality of life. – by James Clark
Disclosure: Califf is an employee of the FDA.
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