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July 6, 2021
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The Food and Drug Administration (FDA) has never been more proactive in recruiting patient advocates in their regulatory and approval processes.
Patient advocates are now routinely recruited to participate in trial designs and regulatory clearances. Such advocates are prized for their experience, their direct engagement with diverse patient populations, including those most affected by the use of the device or drug. Of course it makes sense to include their input.
But what about those who are just as equally affected – the physicians?
It may come as a surprise to many that most physicians lack any input or correspondence with the FDA. Most physicians come to learn of novel devices or drugs through conference meetings or from company representatives.
Most never communicate directly with the FDA.
And just like patient diversity in clinical trials matters, so does physician diversity. The prestigious, academic physicians who oversee most FDA regulatory studies are not the ones who use novel drugs or devices the most.
That would be the physicians in the field – the communities, private practices, and independent physician groups. But these physicians are less likely than their academic counterpart to be involved in FDA studies.
And if that seems inconsequential, just look how vaccine trial representation affected vaccine adoption. Minority populations, distinctly unrepresented in vaccine clinical trials, were less likely to receive the vaccine.
The rationale underlying such complex behavior among different ethnicities is likely more correlative than causative, but racial representation cannot be ignored in the broader picture – and perhaps, if more minorities were willing to participate in the clinical study, then more minorities would be willing to receive the vaccine.
Hope springs eternal, of course. And while the speculative reasoning that a diverse patient population in vaccine trials would lead to more minorities receiving the vaccine is hopelessly oversimplified – nevertheless the narrative persists.
Minority representation remains a critical issue in healthcare post-pandemic, to the point that many insurance companies are prioritizing diverse ethnic representation in the care services offered.
So if insurance companies see this as an issue for patients, then is it much of a stretch for the FDA to see this as an issue for physicians?
The FDA, more than most federal bodies, is noticeably forward looking, always willing to pilot new programs in the best interest of patient safety.
So what better way to represent the safety concerns of patients than to accurately represent the physician population that serves the bulk of patients in this country?
Most patients are served by community hospitals – whether that hospital is nominally part of national conglomerate or a standalone operation – the hospital’s bond to the community transcends the corporate cash flow, and into the personal ethos of the community.
Until we incorporate physician input from physicians who serve patients from these communities, who embody that ethos, we will continue to lack true physician representation – among those who embody patient care in these communities.
Patient advocacy is important, critical in understanding how healthcare innovation impacts the largest, most important stakeholder.
But we must also see physicians as a diverse body, encompassing not just different ethnicities, but different practice backgrounds. A distinction necessary to understand why diverse physician representation is needed at the federal regulatory level.
Hence the need for physician advocates to speak for those in communities who are too busy serving others to speak for themselves.
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Trivia
What we can learn from the 1918 Flu Pandemic as the Omicron variant spreads
Historically, most pandemics end within 2 to 3 years as the virus mutates into a less virulent pathogen and the population builds up immunity. This is what happened to the influenza strain behind the 1918 flu pandemic.